Back to resultsStudy to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC (COMPLEEMENT-1)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ribociclib
Letrozole
Goserelin
Leuprolide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring HR-positive HER2-negative, advanced breast cancer, LEE011, ribociclib, letrozole, goserelin, CDK, CDK4, CDK6, CDK4/6, Phase IIIb, ER-positive, PR-positive, premenopausal, postmenopausal, men with advanced breast cancer
Eligibility Criteria
Key Inclusion Criteria:
- Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
Postmenopausal status is defined either by:
I). Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range (NCCN Guidelines version 2.2017).
Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure menopausal status.
Premenopausal status is defined as either:
I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
- Perimenopausal status is define as neither premenopausal nor postmenopausal Note: Throughout this document, perimenopausal and premenopausal status is grouped together and referred as "Premenopausal"
- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
- Absolute neutrophil count ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin ≥ 9.0 g/dL
- Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
- INR ≤1.5
- Serum creatinine <1.5 mg/dl or creatinine clearance≥50 mL/min
- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
- Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
Patient must have a 12-lead ECG with ALL of the following parameters at screening:
- QTcF interval at screening <450 msec (using Fridericia's correction)
- Resting heart rate ≥ 50 bpm
Key Exclusion Criteria:
- Patient who received any CDK4/6 inhibitor
- Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted
Note:
- Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until study entry.
- Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease must be stopped at least 5 half-lives or 7 days, whichever is longer, before study inclusion.
- Patient is concurrently using other anti-cancer therapy.
Sites / Locations
- Alaska Cancer Research and Education Center
- Ironwood Cancer and Research Centers
- Arizona Oncology Associates
- Arizona Oncology Associates Arizona Oncology Assoc. (2)
- Highlands Oncology Group
- Beverly Hills Cancer Center
- Pacific Shores Medical Group SC
- USC Norris Cancer Center
- University of California Irvine UC Irvine (11)
- Ventura County Hematology and Oncology
- PCR Oncology
- California Pacific Medical Center Onc Dept
- Centura Health Research Center Centura Health Research Center
- Poudre Valley Hospital Poudre Valley Health System
- Valley View Hospital Cancer Center
- Florida Cancer Research Institute Dept of Oncology
- Foundation for Sickle Cell Disease Research
- Watson Clinic Center for Research 1730 Location
- Mid Florida Hematology and Onc Ctr
- Summit Cancer Care Summit Cancer Care (SC)
- John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
- Saint Alphonsus Regional Medical Center
- Stroger Cook County Hospital Division of Hematology & Onc
- Joliet Oncology-Hematology Associates Presence Cancer Center
- Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
- Alpha Med Physician Group, LLC
- Indian Univ Health Goshen Center forCancer SC
- Northwest Oncology
- June E. Nylan Cancer Center
- University of Kansas Medical Center University of Kansas Med Ctr 9
- Sarah Cannon at Overland Park Regional Medical Center
- John Ochsner Heart and Vascular Institute Clinical Trials
- Northern Light Mercy Hospital SC
- Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
- Maryland Oncology Hematology P A Columbia
- Kaiser Permanente
- Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
- Jackson Oncology Associates
- Nebraska Hematology-Oncology, P.C.
- Nebraska Cancer Specialists Oncology Hematology West
- Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
- Trinitas Comprehensive Cancer Center
- Englewood Health
- The Valley Hospital / Luckow Pavillion
- Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
- New Mexico Cancer Care Alliance .
- San Juan Oncology Associates
- Eastchester Center for Cancer Care
- Clinical Research Alliance
- Oncology Speciialists of Charlotte
- Aultman Cancer Center Main Centre
- The Christ Hospital Cancer Center Research Program Linder Research Center
- University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
- Cleveland Clinic Foundation Cleveland Clinic (5)
- Dayton Physicians
- Oklahoma Cancer Specialists and Research Institute SC-2
- Oregon Health Sciences University SC-5
- McLeod Center for Cancer Treatment and Research
- Carolina Blood and Cancer Care of South Carolina
- Millennium Research Clin Develop Millennium Oncology - FL
- Mays Cancer Ctr Uthsa Mdacc
- Hope Cancer Center of East Texas
- Virginia Oncology Associates
- PeaceHealth St Joseph Medical Center
- Providence Regional Medical Centre of Everett
- Kadlec Clinic Hematology and Onco
- Valley Medical Center Research Valley Medical Center
- Virginia Mason Medical Center-Oncology SC
- Northwest Medical Specialties Dept.ofNW Med. Specialties
- Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
- Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ribociclib + letrozole+goserelin/leuprolide
Arm Description
Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s).
SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization. A SAE which caused death of the participant was considered as fatal SAE.
AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE.
A participant with multiple severity grades for an AE is only counted under the maximum grade.
Secondary Outcome Measures
Time-to-Progression (TTP) Based on Investigator's Assessment (Core Phase)
Time to progression (TTP) is defined as time from date of start of treatment to the date of first documented progression or death due to underlying cancer. Participants with symptoms of rapidly progressing disease without radiologic evidence were classified as progression only when clear evidence of clinical deterioration was documented and/or patient discontinued due to 'Disease progression' or death due to study indication. When there was no documentation of radiologic evidence of progression, and the patient discontinued for 'Disease progression' due to documented clinical deterioration of disease, the date of discontinuation was used as date of progression.
TTP was estimated using the Kaplan-Meier method. 95% CI of median was calculated according to Brookmeyer and Crowley method.
Overall Response Rate (ORR) Based on Investigator's Assessment (Core Phase)
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
95% CI was calculated using the exact binomial method.
Clinical Benefit Rate (CBR) Based on Investigator's Assessment (Core Phase)
Clinical benefit rate (CBR) is defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
95% CI was calculated using the exact binomial method.
Change From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score (Core Phase)
Change from baseline in FACT-B scores was assessed. FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL.
Due to the nature of the questionnaire, only females were asked to complete this questionnaire.
Number of Participants With AEs and SAEs in the Extension Phase
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s).
SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization.
AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE.
A participant with multiple severity grades for an AE is only counted under the maximum grade.
Number of Participants With Clinical Benefit (Extension Phase)
Clinical benefit as assessed by the Investigator during Extension phase
Full Information
NCT ID
NCT02941926
First Posted
October 20, 2016
Last Updated
October 23, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02941926
Brief Title
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Acronym
COMPLEEMENT-1
Official Title
COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..
Detailed Description
This was an open-label, single arm, multi-center Phase IIIb study. The study was composed of 2 phases: Core Phase and Extension Phase. In the Core Phase, safety and efficacy data was collected. The study treatment during the Core Phase was provided until disease progression, death, unacceptable toxicities, physician's decision, subject/guardian's decision, protocol deviation, study termination by sponsor, lost to follow-up, technical problems or up to 18 months after LPFV.
In the event that patients were still deriving benefit at the end of the Core phase and ribociclib was not approved or available and reimbursed, patients were transitioned to the Extension Phase and continued to receive study treatment until progression, intolerance, death or physician/patient decision. Only safety and clinical benefit (as assessed by investigator) data was collected in the Extension Phase. During the Extension Phase, if ribociclib became locally approved and reimbursed, patients were to be transitioned to prescription. Patients who completed the Extension Phase and continued to derive clinical benefit from the treatment based on the investigator's evaluation received ribociclib from prescription (if approved and reimbursed), another post-trial access program, or other drug access/support program(s).
Canadian sub-study: this sub-study was a multicenter Canadian exploratory correlative sample collection sub-study that aimed to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy. This sub-study was available for all Canadian subjects enrolled on the main study and did not alter the planned treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HR-positive HER2-negative, advanced breast cancer, LEE011, ribociclib, letrozole, goserelin, CDK, CDK4, CDK6, CDK4/6, Phase IIIb, ER-positive, PR-positive, premenopausal, postmenopausal, men with advanced breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ribociclib + letrozole+goserelin/leuprolide
Arm Type
Experimental
Arm Description
Participants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
Intervention Type
Drug
Intervention Name(s)
Ribociclib
Other Intervention Name(s)
LEE011
Intervention Description
Ribociclib was centrally supplied to the investigators and administered orally once a day on days 1-21 of each 28 day cycle at a starting dose of 600 mg daily
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Description
Goserelin was procured locally and administered in men and premenopausal women as an injectable subcutaneous implant administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 3.6 mg (cycle = 28 days)
Intervention Type
Drug
Intervention Name(s)
Leuprolide
Intervention Description
Leuprolide was procured locally and administered in men and premenopausal women as an injectable intramuscular depot administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 7.5 mg (cycle= 28 days)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
Description
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s).
SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization. A SAE which caused death of the participant was considered as fatal SAE.
AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE.
A participant with multiple severity grades for an AE is only counted under the maximum grade.
Time Frame
From start of treatment up to 30 days after last treatment (for participants who did not enter to the Extension phase) or up to last treatment in the Core phase (for participants who entered the Extension phase), assessed up to approximately 33 months.
Secondary Outcome Measure Information:
Title
Time-to-Progression (TTP) Based on Investigator's Assessment (Core Phase)
Description
Time to progression (TTP) is defined as time from date of start of treatment to the date of first documented progression or death due to underlying cancer. Participants with symptoms of rapidly progressing disease without radiologic evidence were classified as progression only when clear evidence of clinical deterioration was documented and/or patient discontinued due to 'Disease progression' or death due to study indication. When there was no documentation of radiologic evidence of progression, and the patient discontinued for 'Disease progression' due to documented clinical deterioration of disease, the date of discontinuation was used as date of progression.
TTP was estimated using the Kaplan-Meier method. 95% CI of median was calculated according to Brookmeyer and Crowley method.
Time Frame
Up to approximately 33 months
Title
Overall Response Rate (ORR) Based on Investigator's Assessment (Core Phase)
Description
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
95% CI was calculated using the exact binomial method.
Time Frame
Up to approximately 33 months
Title
Clinical Benefit Rate (CBR) Based on Investigator's Assessment (Core Phase)
Description
Clinical benefit rate (CBR) is defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
95% CI was calculated using the exact binomial method.
Time Frame
Up to approximately 33 months
Title
Change From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score (Core Phase)
Description
Change from baseline in FACT-B scores was assessed. FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL.
Due to the nature of the questionnaire, only females were asked to complete this questionnaire.
Time Frame
On Day 1 of Cycle 1, 2, 3, 4 ,5, 6, 8, 10, 12 and after that every 3 cycles, and End of treatment, assessed up to 33 months. Cycle=28 days
Title
Number of Participants With AEs and SAEs in the Extension Phase
Description
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s).
SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization.
AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE.
A participant with multiple severity grades for an AE is only counted under the maximum grade.
Time Frame
From first dose of treatment in the Extension phase up to 30 days after last dose of treatment, assessed up approximately 37.6 months
Title
Number of Participants With Clinical Benefit (Extension Phase)
Description
Clinical benefit as assessed by the Investigator during Extension phase
Time Frame
On Day 1 of every 3 cycles, starting from Cycle 1 of the Extension phase until end of treatment, assessed up to 37.4 months. Cycle= 28 days
Other Pre-specified Outcome Measures:
Title
Canadian Sub-study: Proteomic Analysis of Ribociclib and Letrozole Cohort Not Achieving Clinical Benefit Compared to a Cohort Sensitive to Treatment With Ribociclib and Letrozole
Description
Exploratory analysis performed in archival tumor samples collected during screening in the main study. Protein expression levels of the ribociclib plus letrozole cohort that did not achieve clinical benefit (progression within 3 months of treatment) and the cohort sensitive to ribociclib and letrozole (cohort with a time to progression of 22 months or more) were determined using using Single-Pot, Solid-Phase-enhanced, Sample Preparation-Clinical Tissue Proteomics (SP3-CTP). For normalization purposes a pooled internal standard sample, comprised of aliquots of every sample included in the study, was included in each experimental batch. Protein abundances were calculated as the log2 transformed abundances relative to the pooled internal standard. Positive values represent higher protein expression levels compared to the pooled internal standard. Expression levels of proteins that showed association to predicting response to study treatment are presented.
Time Frame
Screening (up to 28 days before first dose of study treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
In the case of women, both pre/perimenopausal and postmenopausal patients were allowed to be included in this study; menopausal status was relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
Postmenopausal status was defined either by: I).Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient was taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels would be in post-menopausal range per local normal range (NCCN Guidelines version 2.2017).
Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol were needed to ensure menopausal status.
Premenopausal status was defined as either: I).Patient had last menstrual period within the last 12 months OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
Perimenopausal status was define as neither premenopausal nor postmenopausal
Patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Patient had HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test was required by local laboratory testing.
Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Patient had adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
Absolute neutrophil count ≥ 1.5 × 10^9/L
Platelets ≥ 100 × 10^9/L
Hemoglobin ≥ 9.0 g/dL
Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
INR ≤1.5
Serum creatinine <1.5 mg/dl or creatinine clearance≥50 mL/min
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient had liver metastases, ALT and AST should be < 5 × ULN.
Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
Patient must have had a 12-lead ECG with ALL of the following parameters at screening:
QTcF interval at screening <450 msec (using Fridericia's correction)
Resting heart rate ≥ 50 bpm
Key Exclusion Criteria:
Patient who received any CDK4/6 inhibitor
Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease was permitted. Note:
Patients who received (neo) adjuvant therapy for breast cancer were eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval had to be greater than 12 months from the completion of treatment until study entry.
Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial were eligible.
Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease had to be stopped at least 5 half-lives or 7 days, whichever was longer, before study inclusion.
Patient was concurrently using other anti-cancer therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Cancer Research and Education Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates Arizona Oncology Assoc. (2)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pacific Shores Medical Group SC
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Irvine UC Irvine (11)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ventura County Hematology and Oncology
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
PCR Oncology
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
California Pacific Medical Center Onc Dept
City
San Francisco
State/Province
California
ZIP/Postal Code
94120-7999
Country
United States
Facility Name
Centura Health Research Center Centura Health Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Poudre Valley Hospital Poudre Valley Health System
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Valley View Hospital Cancer Center
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Florida Cancer Research Institute Dept of Oncology
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Foundation for Sickle Cell Disease Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Watson Clinic Center for Research 1730 Location
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Mid Florida Hematology and Onc Ctr
City
Orange
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Summit Cancer Care Summit Cancer Care (SC)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Stroger Cook County Hospital Division of Hematology & Onc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Presence Cancer Center
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Alpha Med Physician Group, LLC
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60487
Country
United States
Facility Name
Indian Univ Health Goshen Center forCancer SC
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Northwest Oncology
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
June E. Nylan Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
University of Kansas Medical Center University of Kansas Med Ctr 9
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7330
Country
United States
Facility Name
Sarah Cannon at Overland Park Regional Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
John Ochsner Heart and Vascular Institute Clinical Trials
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Northern Light Mercy Hospital SC
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204-6831
Country
United States
Facility Name
Maryland Oncology Hematology P A Columbia
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Kaiser Permanente
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20879
Country
United States
Facility Name
Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
City
Washington DC
State/Province
Maryland
ZIP/Postal Code
20037
Country
United States
Facility Name
Jackson Oncology Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Nebraska Hematology-Oncology, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Nebraska Cancer Specialists Oncology Hematology West
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Trinitas Comprehensive Cancer Center
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07207
Country
United States
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
The Valley Hospital / Luckow Pavillion
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
New Mexico Cancer Care Alliance .
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Eastchester Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Oncology Speciialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Aultman Cancer Center Main Centre
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
The Christ Hospital Cancer Center Research Program Linder Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation Cleveland Clinic (5)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Dayton Physicians
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute SC-2
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Health Sciences University SC-5
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
McLeod Center for Cancer Treatment and Research
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Carolina Blood and Cancer Care of South Carolina
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Millennium Research Clin Develop Millennium Oncology - FL
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Mays Cancer Ctr Uthsa Mdacc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hope Cancer Center of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
PeaceHealth St Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Medical Centre of Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Kadlec Clinic Hematology and Onco
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Valley Medical Center Research Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Virginia Mason Medical Center-Oncology SC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Northwest Medical Specialties Dept.ofNW Med. Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
La Rioja
ZIP/Postal Code
5300
Country
Argentina
Facility Name
Novartis Investigative Site
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novartis Investigative Site
City
Leoben
ZIP/Postal Code
A 8700
Country
Austria
Facility Name
Novartis Investigative Site
City
Rankweil
ZIP/Postal Code
A-6830
Country
Austria
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Novartis Investigative Site
City
Sint Niklaas
State/Province
Oost Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Novartis Investigative Site
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brussels
ZIP/Postal Code
BE-B-1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Luxembourg
ZIP/Postal Code
1210
Country
Belgium
Facility Name
Novartis Investigative Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Novartis Investigative Site
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
Novartis Investigative Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Novartis Investigative Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Novartis Investigative Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Novartis Investigative Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Novartis Investigative Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Novartis Investigative Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 3G2
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Novartis Investigative Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Novartis Investigative Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G4
Country
Canada
Facility Name
Novartis Investigative Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Novartis Investigative Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K1E1
Country
Canada
Facility Name
Novartis Investigative Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH 7W9
Country
Canada
Facility Name
Novartis Investigative Site
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Novartis Investigative Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Novartis Investigative Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Novartis Investigative Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Novartis Investigative Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Novartis Investigative Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Novartis Investigative Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Novartis Investigative Site
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Novartis Investigative Site
City
Liberec
State/Province
Czech Republic
ZIP/Postal Code
46063
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague 8
State/Province
Czech Republic
ZIP/Postal Code
180 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Zlin
State/Province
Czech Republic
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novartis Investigative Site
City
Olomouc
State/Province
CZE
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czechia
Facility Name
Novartis Investigative Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novartis Investigative Site
City
Oulu
ZIP/Postal Code
FIN-90220
Country
Finland
Facility Name
Novartis Investigative Site
City
Tampere
ZIP/Postal Code
FIN-33521
Country
Finland
Facility Name
Novartis Investigative Site
City
Nice Cedex 2
State/Province
Alpes Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Novartis Investigative Site
City
Dijon
State/Province
Cote D Or
ZIP/Postal Code
21034
Country
France
Facility Name
Novartis Investigative Site
City
Limoges
State/Province
Haute Vienne
ZIP/Postal Code
87000
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Cloud
State/Province
Hauts De Seine
ZIP/Postal Code
92210
Country
France
Facility Name
Novartis Investigative Site
City
Tours 9
State/Province
Indre Et Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Novartis Investigative Site
City
Reims
State/Province
Marne
ZIP/Postal Code
51056
Country
France
Facility Name
Novartis Investigative Site
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Novartis Investigative Site
City
Angers Cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
Novartis Investigative Site
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Novartis Investigative Site
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Novartis Investigative Site
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33000
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novartis Investigative Site
City
Caen
ZIP/Postal Code
14021
Country
France
Facility Name
Novartis Investigative Site
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Novartis Investigative Site
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
Novartis Investigative Site
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans Cedex
ZIP/Postal Code
72015
Country
France
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Novartis Investigative Site
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Novartis Investigative Site
City
Mont de Marsan cedex
ZIP/Postal Code
40024
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Novartis Investigative Site
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Novartis Investigative Site
City
Nantes Cedex
ZIP/Postal Code
44277
Country
France
Facility Name
Novartis Investigative Site
City
Paris 10
ZIP/Postal Code
75475
Country
France
Facility Name
Novartis Investigative Site
City
Paris 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Novartis Investigative Site
City
Perigueux Cedex
ZIP/Postal Code
24004
Country
France
Facility Name
Novartis Investigative Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Novartis Investigative Site
City
Plerin Sur Mer
ZIP/Postal Code
22190
Country
France
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Novartis Investigative Site
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Novartis Investigative Site
City
Toulon La Seyne Sur Mer
ZIP/Postal Code
83056
Country
France
Facility Name
Novartis Investigative Site
City
Troyes
ZIP/Postal Code
10003
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Novartis Investigative Site
City
Ioannina
State/Province
GR
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
54645
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
GR 115 22
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
GR14564
Country
Greece
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
540 07
Country
Greece
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Kowloon
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Pokfulam
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
H 1122
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 034
Country
India
Facility Name
Novartis Investigative Site
City
Tamil Nadu
State/Province
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110092
Country
India
Facility Name
Novartis Investigative Site
City
Admedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 004
Country
India
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
Novartis Investigative Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Novartis Investigative Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700160
Country
India
Facility Name
Novartis Investigative Site
City
Delhi
ZIP/Postal Code
110 085
Country
India
Facility Name
Novartis Investigative Site
City
Beer-Sheva
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Alessandria
State/Province
AL
ZIP/Postal Code
15100
Country
Italy
Facility Name
Novartis Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Novartis Investigative Site
City
L'Aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy
Facility Name
Novartis Investigative Site
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Facility Name
Novartis Investigative Site
City
Asti
State/Province
AT
ZIP/Postal Code
14100
Country
Italy
Facility Name
Novartis Investigative Site
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novartis Investigative Site
City
Treviglio
State/Province
BG
ZIP/Postal Code
24047
Country
Italy
Facility Name
Novartis Investigative Site
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40139
Country
Italy
Facility Name
Novartis Investigative Site
City
Brindisi
State/Province
BR
ZIP/Postal Code
72100
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25124
Country
Italy
Facility Name
Novartis Investigative Site
City
Monserrato
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
Facility Name
Novartis Investigative Site
City
Cuneo
State/Province
CN
ZIP/Postal Code
12100
Country
Italy
Facility Name
Novartis Investigative Site
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95124
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Grosseto
State/Province
GR
ZIP/Postal Code
58100
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Facility Name
Novartis Investigative Site
City
Livorno
State/Province
LI
ZIP/Postal Code
57124
Country
Italy
Facility Name
Novartis Investigative Site
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Facility Name
Novartis Investigative Site
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Novartis Investigative Site
City
Macerata
State/Province
MC
ZIP/Postal Code
62100
Country
Italy
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98158
Country
Italy
Facility Name
Novartis Investigative Site
City
Taormina
State/Province
ME
ZIP/Postal Code
98039
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20121
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
Novartis Investigative Site
City
Nuoro
State/Province
NU
ZIP/Postal Code
08100
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Novartis Investigative Site
City
Prato
State/Province
PO
ZIP/Postal Code
59100
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Fano
State/Province
PU
ZIP/Postal Code
61032
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89124
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00152
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
Novartis Investigative Site
City
Salerno
State/Province
SA
ZIP/Postal Code
84131
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
Facility Name
Novartis Investigative Site
City
Savona
State/Province
SV
ZIP/Postal Code
17100
Country
Italy
Facility Name
Novartis Investigative Site
City
Trento
State/Province
TN
ZIP/Postal Code
38100
Country
Italy
Facility Name
Novartis Investigative Site
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Terni
State/Province
TR
ZIP/Postal Code
05100
Country
Italy
Facility Name
Novartis Investigative Site
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
Facility Name
Novartis Investigative Site
City
Saronno
State/Province
VA
ZIP/Postal Code
21047
Country
Italy
Facility Name
Novartis Investigative Site
City
Mirano
State/Province
VE
ZIP/Postal Code
30035
Country
Italy
Facility Name
Novartis Investigative Site
City
Negrar
State/Province
VR
ZIP/Postal Code
37024
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Viterbo
State/Province
VT
ZIP/Postal Code
01100
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Novartis Investigative Site
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
10999
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Tanjong Bungah
State/Province
Penang
ZIP/Postal Code
11200
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46050
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Putrajaya
State/Province
Wilayah Persekutuan
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
ZIP/Postal Code
04700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico City
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Novartis Investigative Site
City
Maastricht
State/Province
AZ
ZIP/Postal Code
5800
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Venray
State/Province
CE
ZIP/Postal Code
5801
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Apeldoorn
State/Province
DZ
ZIP/Postal Code
7334
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Dordrecht
ZIP/Postal Code
3318AT
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Ede
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hilversum
ZIP/Postal Code
XZ1213
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3543 AZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Facility Name
Novartis Investigative Site
City
Stavanger
ZIP/Postal Code
NO-4068
Country
Norway
Facility Name
Novartis Investigative Site
City
Muscat
ZIP/Postal Code
123
Country
Oman
Facility Name
Novartis Investigative Site
City
Panama City
ZIP/Postal Code
0801
Country
Panama
Facility Name
Novartis Investigative Site
City
Taguig City
State/Province
Metro Manila
ZIP/Postal Code
1634
Country
Philippines
Facility Name
Novartis Investigative Site
City
Las Pinas
ZIP/Postal Code
1740
Country
Philippines
Facility Name
Novartis Investigative Site
City
San Juan City
ZIP/Postal Code
1500
Country
Philippines
Facility Name
Novartis Investigative Site
City
Zory
State/Province
Slaskie
ZIP/Postal Code
44-240
Country
Poland
Facility Name
Novartis Investigative Site
City
Bydgoszcz
ZIP/Postal Code
85 796
Country
Poland
Facility Name
Novartis Investigative Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80 952
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novartis Investigative Site
City
Lublin
ZIP/Postal Code
20 090
Country
Poland
Facility Name
Novartis Investigative Site
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Novartis Investigative Site
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 781
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
53 413
Country
Poland
Facility Name
Novartis Investigative Site
City
Braga
ZIP/Postal Code
4710243
Country
Portugal
Facility Name
Novartis Investigative Site
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1500 650
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Leningrad Region
State/Province
Russia
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow Region Istra Village
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow Rerion Balashiha
ZIP/Postal Code
143900
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Rostov-na-Donu
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Dammam
ZIP/Postal Code
15215
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Makkah
ZIP/Postal Code
57657
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
217562
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
258500
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Novartis Investigative Site
City
Banska Bystrica
State/Province
Slovak Republic
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04191
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Novartis Investigative Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Novartis Investigative Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Novartis Investigative Site
City
Almeria
State/Province
Andalucia
ZIP/Postal Code
04009
Country
Spain
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18014
Country
Spain
Facility Name
Novartis Investigative Site
City
Huelva
State/Province
Andalucia
ZIP/Postal Code
21005
Country
Spain
Facility Name
Novartis Investigative Site
City
Jaen
State/Province
Andalucia
ZIP/Postal Code
23007
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Jerez
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Novartis Investigative Site
City
Toledo
State/Province
Castilla La Mancha
ZIP/Postal Code
45071
Country
Spain
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08024
Country
Spain
Facility Name
Novartis Investigative Site
City
Lerida
State/Province
Cataluna
ZIP/Postal Code
25198
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Girona
State/Province
Catalunya
ZIP/Postal Code
17007
Country
Spain
Facility Name
Novartis Investigative Site
City
Hospitalet de LLobregat
State/Province
Catalunya
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03550
Country
Spain
Facility Name
Novartis Investigative Site
City
Castellon
State/Province
Comunidad Valenciana
ZIP/Postal Code
12002
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46015
Country
Spain
Facility Name
Novartis Investigative Site
City
Badajoz
State/Province
Extremadura
ZIP/Postal Code
06080
Country
Spain
Facility Name
Novartis Investigative Site
City
Caceres
State/Province
Extremadura
ZIP/Postal Code
10003
Country
Spain
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigative Site
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Novartis Investigative Site
City
Las Palmas De Gran Canarias
State/Province
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Novartis Investigative Site
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
San Sebastian
State/Province
Pais Vasco
ZIP/Postal Code
20080
Country
Spain
Facility Name
Novartis Investigative Site
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36212
Country
Spain
Facility Name
Novartis Investigative Site
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Novartis Investigative Site
City
Granollers
ZIP/Postal Code
08402
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novartis Investigative Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Gothenburg
ZIP/Postal Code
SE-431 45
Country
Sweden
Facility Name
Novartis Investigative Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
SE-118 83
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Vaxjo
ZIP/Postal Code
SE-351 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Songkhla
State/Province
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Khon Kaen
State/Province
THA
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novartis Investigative Site
City
Peterborough
State/Province
Cambridgeshire
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Portsmouth
State/Province
Hants
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Ipswich
State/Province
Suffolk
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW1 2PJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W8 6RF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Citations:
PubMed Identifier
36267663
Citation
Caputo R, Fabi A, Romagnoli E, Baldini E, Grasso D, Fenderico N, Michelotti A. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial. Breast Cancer (Dove Med Press). 2022 Oct 18;14:351-362. doi: 10.2147/BCTT.S376902. eCollection 2022.
Results Reference
derived
PubMed Identifier
36206609
Citation
Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, Vidal M, Jimenez-Rodriguez B, De la Cruz Merino L, Martinez Janez N, Villanueva Vazquez R, de Toro Salas R, Anton Torres A, Alvarez Lopez IM, Gavila Gregori J, Quiroga Garcia V, Vicente Rubio E, De la Haba-Rodriguez J, Gonzalez-Santiago S, Diaz Fernandez N, Barnadas Molins A, Cantos Sanchez de Ibarguen B, Delgado Mingorance JI, Bellet Ezquerra M, de Casa S, Gimeno A, Martin M. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast. 2022 Dec;66:77-84. doi: 10.1016/j.breast.2022.09.006. Epub 2022 Sep 28.
Results Reference
derived
PubMed Identifier
36152144
Citation
De Laurentiis M, Caputo R, Mazza M, Mansutti M, Masetti R, Ballatore Z, Torrisi R, Michelotti A, Zambelli A, Ferro A, Generali D, Vici P, Coltelli L, Fabi A, Marchetti P, Ballestrero A, Spazzapan S, Frassoldati A, Sarobba MG, Grasso D, Zamagni C. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. Target Oncol. 2022 Nov;17(6):615-625. doi: 10.1007/s11523-022-00913-x. Epub 2022 Sep 24.
Results Reference
derived
PubMed Identifier
35212906
Citation
Campone M, De Laurentiis M, Zamagni C, Kudryavcev I, Agterof M, Brown-Glaberman U, Palacova M, Chatterjee S, Menon-Singh L, Wu J, Martin M. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.
Results Reference
derived
PubMed Identifier
34414532
Citation
De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19. Erratum In: Breast Cancer Res Treat. 2021 Oct 8;:
Results Reference
derived
Learn more about this trial
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
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