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A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi (BELLE-3)

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fulvestrant
BKM120
BKM120 matching placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring BKM120, fulvestrant, breast cancer, metastatic, locally advanced, AI treated, mTOR inhibitor, PI3K, PIK3CA, PTEN, HER2-, HR+

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key inclusion criteria

  • Female patients age 18 years or older
  • Histologically and/or cytologically confirmed diagnosis of breast cancer
  • Radiologic evidence of inoperable locally advanced or metastatic breast cancer
  • Adequate tumor tissue for the analysis of PI3K-related biomarkers
  • Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
  • Postmenopausal women
  • Prior treatment with aromatase inhibitors
  • Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
  • Adequate bone marrow and organ function
  • ECOG performance status ≤ 2

Key exclusion criteria

  • Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant
  • More than one chemotherapy line for metastatic disease
  • Hypersensitivity to any of the excipients of buparlisib or fulvestrant
  • Symptomatic central nervous system metastases
  • Concurrent malignancy or malignancy within 3 years of study enrollment
  • Certain drugs or radiation within 2-4 weeks of enrollment
  • Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent
  • Certain scores on an anxiety and depression mood questionnaire given at screening
  • Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
  • Active cardiac disease or a history of cardiac dysfunction

Sites / Locations

  • University of South Alabama / Mitchell Cancer Institute Univ South AL
  • Ironwood Cancer and Research Centers SC
  • Highlands Oncology Group
  • Compassionate Cancer Care Medical Group CCCMG
  • Los Angeles Hematology/Oncology Medical Group Onc Dept.
  • Cedars Sinai Medical Center SC-5
  • University of California at Los Angeles UCLA SC
  • Pacific Cancer Care
  • Rocky Mountain Cancer Centers SC
  • University Cancer & Blood Center, LLC
  • Emory University School of Medicine/Winship Cancer Institute Emory
  • Moanalua Medical Center. Attn: Oncology Dept
  • Edward Hospital Edward Hospital
  • Crescent City Research Consortium, LLC SC
  • Lsu Health Sciences Center/ Lsu School of Medicine Lsu
  • John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2
  • LSU Health Sciences Center Feist-Weiller Cancer Center
  • University of Maryland Medical Center Univ Maryland
  • Mercy Medical Research Institute SC
  • Morristown Memorial Hospital Morristown Mem
  • CINJ at Cooper University Hospital Dept of Onc
  • Montefiore Medical Center Montefiore
  • Clinical Research Alliance BKM120F2303
  • Clinical Research Alliance
  • Northwest Cancer Specialists Compass Oncology -BKM
  • Oregon Health and Science University SC-5
  • University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
  • The West Clinic Dept. of the West Clinic
  • Texas Oncology PA Dallas Presbyterian Hospital SC
  • Texas Oncology Texas Oncology - Sammons
  • Texas Oncology P A SC-Austin
  • Texas Oncology P A Texas Oncology - Fort Worth (3
  • University of Texas Southwestern Medical Center
  • Texas Tech University Health Science Center Dept of Texas Tech
  • The Methodist Hospital Cancer Center
  • US Oncology, P.A.
  • Northwest Medical Specialties
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BKM120 100mg + Fulvestrant

Placebo + Fulvestrant

Arm Description

BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.

BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.

Secondary Outcome Measures

Overall Survival (OS) - Full Analysis Set (FAS)
Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.
Progression Free Survival (PFS) by PIK3CA Mutational Status
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.
Overall Survival (OS) by PIK3CA Mutational Status
Overall Survival (OS) by PIK3CA mutational status based on ctDNA is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.
Overall Response Rate (ORR) by PIK3CA Mutational Status
Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (< 10 mm short axis)); Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization.
Clinical Benefit Rate (CBR) by PIK3CA Mutational Status
Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization.
Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.
Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)
Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).
Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)
Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)
The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL.
Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)
The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.

Full Information

First Posted
June 29, 2012
Last Updated
January 9, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01633060
Brief Title
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Acronym
BELLE-3
Official Title
A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Novartis decided not to pursue further development of buparlisib program (assessment of moderate PFS benefit with know, but manageable, buparlisib profile).
Study Start Date
October 3, 2012 (Actual)
Primary Completion Date
May 23, 2016 (Actual)
Study Completion Date
September 21, 2017 (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
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
Detailed Description
Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
BKM120, fulvestrant, breast cancer, metastatic, locally advanced, AI treated, mTOR inhibitor, PI3K, PIK3CA, PTEN, HER2-, HR+

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BKM120 100mg + Fulvestrant
Arm Type
Experimental
Arm Description
BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
Arm Title
Placebo + Fulvestrant
Arm Type
Placebo Comparator
Arm Description
BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
Intervention Type
Drug
Intervention Name(s)
BKM120
Intervention Description
BKM120 100 mg once daily
Intervention Type
Drug
Intervention Name(s)
BKM120 matching placebo
Intervention Description
BKM120 matching placebo, once daily
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)
Description
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.
Time Frame
Every 6 weeks after randomization up to a maximum of 4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS) - Full Analysis Set (FAS)
Description
Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.
Time Frame
Every 6 weeks after randomization up to a maximum of 5 years
Title
Progression Free Survival (PFS) by PIK3CA Mutational Status
Description
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.
Time Frame
Every 6 weeks after randomization up to a maximum of 5 years
Title
Overall Survival (OS) by PIK3CA Mutational Status
Description
Overall Survival (OS) by PIK3CA mutational status based on ctDNA is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.
Time Frame
Every 6 weeks after randomization up to a maximum of 5 years
Title
Overall Response Rate (ORR) by PIK3CA Mutational Status
Description
Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (< 10 mm short axis)); Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization.
Time Frame
Every 6 weeks after randomization up to a maximum of 5 years
Title
Clinical Benefit Rate (CBR) by PIK3CA Mutational Status
Description
Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization.
Time Frame
Week 14, Week 24
Title
Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)
Description
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.
Time Frame
From first dose of study treatment to 30 days after last dose of study treatment, up to 5 years
Title
Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)
Description
Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).
Time Frame
C1D1 1 hour post dose, C1D1 2 hour post dose, C1D1 6 hour post dose and C1D1 9 hour post dose
Title
Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)
Description
Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.
Time Frame
C1D15, C2D1, C3D1 and C4D1
Title
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)
Description
The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL.
Time Frame
Baseline, Week 6 (C2D15), Week 12 (C4D1), then every 8 weeks until discontinuation (a cycle [C] = 4 weeks) up to 5 years.
Title
Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)
Description
The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.
Time Frame
Screening, Baseline (Cycle 1 Day 1) and then at day 1 of each cycle and at the EOT visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria Female patients age 18 years or older Histologically and/or cytologically confirmed diagnosis of breast cancer Radiologic evidence of inoperable locally advanced or metastatic breast cancer Adequate tumor tissue for the analysis of PI3K-related biomarkers Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status Postmenopausal women Prior treatment with aromatase inhibitors Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry Adequate bone marrow and organ function ECOG performance status ≤ 2 Key exclusion criteria Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant More than one chemotherapy line for metastatic disease Hypersensitivity to any of the excipients of buparlisib or fulvestrant Symptomatic central nervous system metastases Concurrent malignancy or malignancy within 3 years of study enrollment Certain drugs or radiation within 2-4 weeks of enrollment Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent Certain scores on an anxiety and depression mood questionnaire given at screening Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus Active cardiac disease or a history of cardiac dysfunction
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
University of South Alabama / Mitchell Cancer Institute Univ South AL
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Ironwood Cancer and Research Centers SC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Compassionate Cancer Care Medical Group CCCMG
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Los Angeles Hematology/Oncology Medical Group Onc Dept.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Cedars Sinai Medical Center SC-5
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California at Los Angeles UCLA SC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Rocky Mountain Cancer Centers SC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University Cancer & Blood Center, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Emory University School of Medicine/Winship Cancer Institute Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Moanalua Medical Center. Attn: Oncology Dept
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Edward Hospital Edward Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Crescent City Research Consortium, LLC SC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Lsu Health Sciences Center/ Lsu School of Medicine Lsu
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
LSU Health Sciences Center Feist-Weiller Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122-2822
Country
United States
Facility Name
University of Maryland Medical Center Univ Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Medical Research Institute SC
City
Manchester
State/Province
Missouri
ZIP/Postal Code
63021
Country
United States
Facility Name
Morristown Memorial Hospital Morristown Mem
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
CINJ at Cooper University Hospital Dept of Onc
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Montefiore Medical Center Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Clinical Research Alliance BKM120F2303
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Northwest Cancer Specialists Compass Oncology -BKM
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health and Science University SC-5
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
The West Clinic Dept. of the West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology PA Dallas Presbyterian Hospital SC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology Texas Oncology - Sammons
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology P A SC-Austin
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Texas Oncology P A Texas Oncology - Fort Worth (3
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Tech University Health Science Center Dept of Texas Tech
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
The Methodist Hospital Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology, P.A.
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1050AAK
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
Rio Negro
State/Province
Viedma
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Novartis Investigative Site
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1000
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
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4000
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
1756
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Novartis Investigative Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigative Site
City
Monteria
Country
Colombia
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
Limoges cedex
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
Reims Cedex
State/Province
Marne
ZIP/Postal Code
51056
Country
France
Facility Name
Novartis Investigative Site
City
Angers Cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
Novartis Investigative Site
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Novartis Investigative Site
City
Rouen Cedex 1
ZIP/Postal Code
76038
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Brieuc Cédex
ZIP/Postal Code
22015
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Herblain Cédex
ZIP/Postal Code
44805
Country
France
Facility Name
Novartis Investigative Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Novartis Investigative Site
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Novartis Investigative Site
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24103
Country
Germany
Facility Name
Novartis Investigative Site
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Mühlhausen
ZIP/Postal Code
99974
Country
Germany
Facility Name
Novartis Investigative Site
City
Ravensburg
ZIP/Postal Code
88214
Country
Germany
Facility Name
Novartis Investigative Site
City
Soest
ZIP/Postal Code
59494
Country
Germany
Facility Name
Novartis Investigative Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novartis Investigative Site
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Novartis Investigative Site
City
Marousi
State/Province
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
151 23
Country
Greece
Facility Name
Novartis Investigative Site
City
Larissa
State/Province
GR
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Novartis Investigative Site
City
Patra - RIO
State/Province
GR
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Novartis Investigative Site
City
Thesaloniki
State/Province
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
GR-115 22
Country
Greece
Facility Name
Novartis Investigative Site
City
Heraklion Crete
ZIP/Postal Code
711 10
Country
Greece
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
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Novartis Investigative Site
City
L'Aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novartis Investigative Site
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
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
Monserrato
State/Province
CA
ZIP/Postal Code
09042
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
95100
Country
Italy
Facility Name
Novartis Investigative Site
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Sora
State/Province
FR
ZIP/Postal Code
03039
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
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
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
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41124
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
Pordenone
State/Province
PN
ZIP/Postal Code
33170
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
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
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Salerno
State/Province
SA
ZIP/Postal Code
84131
Country
Italy
Facility Name
Novartis Investigative Site
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
Facility Name
Novartis Investigative Site
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Novartis Investigative Site
City
Ivrea
State/Province
TO
ZIP/Postal Code
10015
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Mirano
State/Province
VE
ZIP/Postal Code
30035
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Frattamaggiore
ZIP/Postal Code
80020
Country
Italy
Facility Name
Novartis Investigative Site
City
Gyeonggi-do
State/Province
Korea
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Beirut
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Maastricht
State/Province
AZ
ZIP/Postal Code
5800
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Delft
ZIP/Postal Code
NL 2625 AD
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10226
Country
Poland
Facility Name
Novartis Investigative Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
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
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
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
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
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
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28007
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
Santa Cruz de Tenerife
ZIP/Postal Code
38009
Country
Spain
Facility Name
Novartis Investigative Site
City
Kalmar
ZIP/Postal Code
SE-391 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Blackburn
State/Province
Lancashire
ZIP/Postal Code
BB2 3HH
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
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M20 2BX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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 www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
29223745
Citation
Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7. Erratum In: Lancet Oncol. 2018 Mar;19(3):e137.
Results Reference
derived

Learn more about this trial

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

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