Back to resultsTrial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (ASCENT)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sacituzumab govitecan
Eribulin
Capecitabine
Gemcitabine
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.
- Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.
- Prior exposure to a taxane in localized or advanced/metastatic setting.
- Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.
- At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).
- At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
- Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin ≤ 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin ≥3 g/dL).
- Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
- Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
Key Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.
- Participants with Gilbert's disease.
- Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.
- Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.
- Infection requiring antibiotic use within one week of randomization.
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Southern Cancer Center, 29653 Anchor Cross Blvd
- Souther Cancer Center, 3719 Dauphin St., 5 Floor
- Southern Cancer Center, 3 Mobile Infirmary Circle
- Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level
- Mayo Clinic Hospital
- Mayo Clinic Hospital
- UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200
- UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200
- UCLA Jonsson Comprehensive Cancer Center
- UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza
- UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320
- University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street
- UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard
- Rocky Mountain Cancer Centers, 1700 South Potomac Street
- University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court
- Rocky Mountain Cancer Centers, 4715 Arapahoe Ave
- Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400
- Rocky Mountain Cancer Centers, 1800 Williams St.
- Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400
- Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450
- Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100
- Rocky Mountain Cancer Centers, 22 West Dry Creek Circle
- Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01
- Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210
- Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421
- Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350
- Rocky Mountain Cancer Centers, 8820 Huron Street
- Yale School Of Medicine
- Norwalk Hospital, 34 Maple Street
- Georgetown Lombardi Comprehensive Cancer Center
- Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive
- Florida Cancer Specialist
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 403 S. King Ave
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road
- Sylvester Comprehensive Cancer Center
- Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway
- Sylvester Comprehensive Cancer Center
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing
- Florida Cancer Specialists & Research Institute, 100 Highland Avenue
- Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway
- Sylvester Comprehensive Cancer Center
- Baptist Health Medical Group Oncology, LLC
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd
- Florida Cancer Specialists & Research Institute, 1630 SE 18th ST
- Florida Cancer Specialists & Research Institute, 765 Image Way
- Orlando Regional Medical Center
- Florida Cancer Specialists & Research Institute, 70 W Gore Street
- Florida Cancer Specialists & Research Institute - 325 Clyde Morris
- Sylvester Comprehensive Cancer Center
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North
- Florida Cancer Specialists & Research Institute, 560 Jackson St
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive
- Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard
- Florida Cancer Specialists & Research Institute, 4100 Waterman Way
- Florida Cancer Specialists & Research Institute, 1400 US highway 441 N
- Florida Cancer Specialists
- Florida Cancer Specialists
- Florida Cancer Specialists & Research Institute - 3730 7th Terrace
- Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B
- Florida Cancer Specialists & Research Institute1309 N Flagler Dr
- Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive
- Atlanta Cancer Center - Alpharetta
- University Cancer & Blood Center, 3320 Old Jefferson Rd
- GCS/Annex
- Atlanta Cancer Care - Atlanta
- Northside Hospital
- GCS/Canton
- Atlanta Cancer Care - Conyers
- Atlanta Cancer Care - Cumming
- Atlanta Cancer Care - Decatur
- GCS/Stemmer
- Atlanta Cancer Care - Stockbridge
- GCS/Macon
- GCS/Kennestone
- GCS/Northside
- Illinois Cancer Specialists
- University of Chicago Medical Center 5841 S. Maryland Ave
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd
- Illinois Cancer Specialists
- Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd
- MidAmerica Division Inc. c/o Menorah Medical Center
- University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Maryland Oncology Hematology
- Dana-Farber Cancer Institute
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center (BIDMC)
- Mass General - North Shore Cancer Center ( NSCC )
- Mercy Hospital
- Minnesota Oncology Hematology P.A.
- Suburban Imaging Northwest
- Suburban Imaging
- Mercy Hospital - Unity Campus AHL
- Minnesota Oncology Hematology P.A.
- Minnesota Oncology Hematology P.A.
- Abbot Northwestern Hospital
- Virginia G. Piper Cancer Center at HonorHealth
- Mayo Clinic - 200 First Street SW
- Washington University School of Medicine in St. Louis
- MidAmerica Division Inc. c/o Menorah Medical Center
- Research Medical Center
- Washington University School of Medicine in St. Louis
- Washington University School of Medicine in St. Louis
- Washington University School of Medicine in St. Louis
- Nebraska Cancer Specialists - Midwest Cancer Center - Papillion
- Nebraska Cancer Specialists - Midwest Cancer Center - Paillion
- Nebraska Cancer Specialists- Midwest Cancer Center- Papillion
- Rutgers Cancer Institute of New Jersey
- New York Oncology Hematology, P.C.
- New York Oncology Hematology, P.C.
- North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16
- UNC Health Care System
- The Ohio State University Wexner Medical Center, 460 W 10th Ave
- The Ohio State University Wexner Medical Center, 1145 Olentangy River Road
- Providence Medical Group
- UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
- UPMC Hillman Cancer Center UPMC East
- UPMC Hillman Cancer Center Upper Saint Clair
- Allegheny-Singer Research Institute, 320 East North Avenue
- Magee-Womens Hospital of UPMC
- UPMC Hillman Cancer Center UPMC Passavant
- Tennessee Oncology - Chattanooga Oncology & Hematology Associates
- Tennesee Oncology - PLLC
- Tenesse Oncology - PLLC
- Tennessee Oncology, LLC
- Tennessee Ocology, LLC
- Tennessee Oncology, LLC
- West Cancer Center, 7945 Wolf River Blvd
- Tennessee Oncology, LLC
- Tennessee Oncology, LLC
- Tennessee Oncology, LLC
- Sarah Cannon Cancer Institute/Tennessee Oncology
- Tennessee Oncology, LLC
- Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000
- Tennessee Ocology, LLC
- Tennessee Oncology, LLC
- Tenessee Oncology
- Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232
- Vanderbilt-Ingram Cancer Center
- Tennessee Oncology, LLC
- Center for Cancer and Blood Disorders
- Center for Cancer and Blood Disorders
- Texas Oncology- Medical City Dallas Building D
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
- Texas Oncology
- Center for Cancer and Blood Disorders
- Houston Methodist Hospital - 6565 Fannin St
- Texas Oncology-Longview Cancer Center
- Texas Oncology
- US Oncology
- Center for Cancer and Blood Disorders
- Virginia Cancer Specialists, PC
- Virginia Cancer Specialists, PC
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Virginia Oncology Associates
- Virginia Cancer Specialists, PC
- Virginia Cancer Specialists, PC
- Virginia Oncology Associates
- Virginia Cancer Specialists, PC
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Virginia Oncology Associates
- Virginia Oncology Associates, P.C.
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Virginia Oncology Associates
- Virginia Cancer Specialists, PC
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Swedish Cancer Institute
- Swedish Cancer Institute
- Swedish Cancer Institute
- Swedish Cancer Institute
- Universitair Zlekenhuis Brussel
- Institut Jules Bordet
- UZ Leuven
- Clinique et Maternite Sainte-Elisabeth
- Cross Cancer Institute, 11560 University Avenue
- Queen Elizabeth II Health Sciences Centre
- Sunnybrook Health Sciences Centre
- Jewish General Hospital, 3755 Côte-Sainte-Catherine
- Jewish General Hospital, 3755 Côte-Sainte-Catherine
- Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin
- CHU Besançon - Hôpital Jean Minjoz
- Institut Régional du Cancer de Montpellier
- Institut Curie
- Centre Eugène Marquis
- Florence Lerebours
- CHU de Nantes - Hôpital Nord Laennec
- Institut Claudius Regaud
- Gustave Roussy
- Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
- Praxis für interdisziplinäre Onkologie & Hämatologie GbR
- Facharztzentrum Eppendorf
- Institut für Versorgungsforschung in der Onkologie
- Praxis für Hämatologie und Internistische Onkologie
- Hospital Teresa Herrera, As Xubias, 84
- Hospital Quirón Barcelona, Plaza Alfonso Comín 5
- Hospital del Mar
- Hospital Universitario Vall d'Hebron
- Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90
- Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203
- Hospital Universitari Arnau de Vilanova de Lleida
- Hospital Universitario Ramon y Cajal
- Hospital Universitario 12 de Octubre
- Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario
- Hospital Universitario Virgen del Rocío
- Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
- The Arden Cancer Centre- University Hospital Coventry
- County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham
- The Royal Surrey County Hospital NHS Foundation Trust
- The County Hospital, Wye Valley NHS Trust
- The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology
- The Christie NHS Foundation Trust
- Nottingham University Hospitals NHS Trust - City Hospital
- Plymouth Hospitals NHS Trust - Derriford Hospital
- Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital
- The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sacituzumab Govitecan
Treatment of Physician's Choice (TPC)
Arm Description
Participants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
Participants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Secondary Outcome Measures
Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Overall Survival (OS) in BM-ve Population
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Overall Survival (OS) in ITT Population
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time to Objective Response by the Investigator Assessment in BM-ve Population
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time to Objective Response by the IRC Assessment in BM-ve Population
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.
Time to Progression (TTP) by Investigator Assessment in BM-ve Population
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Time to Progression (TTP) by IRC Assessment in BM-ve Population
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
Fatal
Life-threatening
Disabling/incapacitating
Results in hospitalization or prolongs a hospital stay
A congenital abnormality
Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement.
Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02574455
Brief Title
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
Acronym
ASCENT
Official Title
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
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
The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
529 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sacituzumab Govitecan
Arm Type
Experimental
Arm Description
Participants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
Arm Title
Treatment of Physician's Choice (TPC)
Arm Type
Active Comparator
Arm Description
Participants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab govitecan
Other Intervention Name(s)
IMMU-132, Trodelvy®
Intervention Description
10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour.
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Halaven
Intervention Description
Administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1000 to 1250 mg/m^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
800 to 1200 mg/m^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
25 mg/m^2 will be administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
Description
PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Time Frame
From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
Description
PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Time Frame
From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Overall Survival (OS) in BM-ve Population
Description
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Time Frame
From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Title
Overall Survival (OS) in ITT Population
Description
Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Time Frame
From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Title
Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
Description
ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame
From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Time to Objective Response by the Investigator Assessment in BM-ve Population
Description
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame
From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Time to Objective Response by the IRC Assessment in BM-ve Population
Description
Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame
From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
Description
DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.
Time Frame
From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Time to Progression (TTP) by Investigator Assessment in BM-ve Population
Description
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Time Frame
From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Time to Progression (TTP) by IRC Assessment in BM-ve Population
Description
Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Time Frame
From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
Description
CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame
From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Title
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
Description
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
Fatal
Life-threatening
Disabling/incapacitating
Results in hospitalization or prolongs a hospital stay
A congenital abnormality
Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above
Time Frame
First dose date up to last follow-up (maximum up to 30.8 months)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement.
Time Frame
Baseline; End of Treatment (EOT) (up to 29.6 months)
Title
Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
Description
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
Time Frame
First dose date up to last follow-up (maximum up to 30.8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.
Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.
Prior exposure to a taxane in localized or advanced/metastatic setting.
Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.
At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).
At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin ≤ 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin ≥3 g/dL).
Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
Key Exclusion Criteria:
Women who are pregnant or lactating.
Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.
Participants with Gilbert's disease.
Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.
Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.
Infection requiring antibiotic use within one week of randomization.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, 29653 Anchor Cross Blvd
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Souther Cancer Center, 3719 Dauphin St., 5 Floor
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Southern Cancer Center, 3 Mobile Infirmary Circle
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic Hospital
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard
City
Santa Monica
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 1700 South Potomac Street
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-5405
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 4715 Arapahoe Ave
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 1800 Williams St.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 22 West Dry Creek Circle
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Rocky Mountain Cancer Centers, 8820 Huron Street
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Yale School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3206
Country
United States
Facility Name
Norwalk Hospital, 34 Maple Street
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Georgetown Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Cancer Specialist
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Florida Cancer Specialists
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 403 S. King Ave
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Florida Cancer Specialists
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33914
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 100 Highland Avenue
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Health Medical Group Oncology, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 1630 SE 18th ST
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 765 Image Way
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-2008
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 70 W Gore Street
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute - 325 Clyde Morris
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32774
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Cancer Specialists
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705-1449
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 560 Jackson St
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 4100 Waterman Way
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 1400 US highway 441 N
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute - 3730 7th Terrace
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B
City
Wellington
State/Province
Florida
ZIP/Postal Code
98374
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute1309 N Flagler Dr
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401-3406
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Atlanta Cancer Center - Alpharetta
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
University Cancer & Blood Center, 3320 Old Jefferson Rd
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
GCS/Annex
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Atlanta Cancer Care - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GCS/Canton
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Atlanta Cancer Care - Conyers
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Atlanta Cancer Care - Cumming
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Atlanta Cancer Care - Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GCS/Stemmer
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Atlanta Cancer Care - Stockbridge
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
GCS/Macon
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
GCS/Kennestone
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GCS/Northside
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
University of Chicago Medical Center 5841 S. Maryland Ave
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714-5905
Country
United States
Facility Name
Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
MidAmerica Division Inc. c/o Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205-2005
Country
United States
Facility Name
Maryland Oncology Hematology
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Maryland Oncology Hematology
City
Brandywine
State/Province
Maryland
ZIP/Postal Code
20613
Country
United States
Facility Name
Maryland Oncology Hematology
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Maryland Oncology Hematology
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Maryland Oncology Hematology
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Maryland Oncology Hematology
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Maryland Oncology Hematology
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2621
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Mass General - North Shore Cancer Center ( NSCC )
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Suburban Imaging Northwest
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Suburban Imaging
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Mercy Hospital - Unity Campus AHL
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Abbot Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Virginia G. Piper Cancer Center at HonorHealth
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic - 200 First Street SW
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
MidAmerica Division Inc. c/o Menorah Medical Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Nebraska Cancer Specialists - Midwest Cancer Center - Papillion
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Nebraska Cancer Specialists - Midwest Cancer Center - Paillion
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Nebraska Cancer Specialists- Midwest Cancer Center- Papillion
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046-5706
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
UNC Health Care System
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Ohio State University Wexner Medical Center, 460 W 10th Ave
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432100
Country
United States
Facility Name
The Ohio State University Wexner Medical Center, 1145 Olentangy River Road
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Providence Medical Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
UPMC Hillman Cancer Center UPMC East
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
UPMC Hillman Cancer Center Upper Saint Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15102
Country
United States
Facility Name
Allegheny-Singer Research Institute, 320 East North Avenue
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Hillman Cancer Center UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-1108
Country
United States
Facility Name
Tennesee Oncology - PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tenesse Oncology - PLLC
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37311
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Ocology, LLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
West Cancer Center, 7945 Wolf River Blvd
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
28138
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Sarah Cannon Cancer Institute/Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Tennessee Ocology, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tenessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Tennessee Oncology, LLC
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Texas Oncology- Medical City Dallas Building D
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-6899
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2006
Country
United States
Facility Name
Texas Oncology
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4611
Country
United States
Facility Name
Houston Methodist Hospital - 6565 Fannin St
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology-Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7753
Country
United States
Facility Name
US Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Virginia Oncology Associates
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031-4629
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Virginia Oncology Associates
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
Virginia Oncology Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Virginia Oncology Associates, P.C.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-0026
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Virginia Oncology Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Wytheville
State/Province
Virginia
ZIP/Postal Code
24382
Country
United States
Facility Name
Swedish Cancer Institute
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Swedish Cancer Institute
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Universitair Zlekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique et Maternite Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Cross Cancer Institute, 11560 University Avenue
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
TG6 1Z2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital, 3755 Côte-Sainte-Catherine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Jewish General Hospital, 3755 Côte-Sainte-Catherine
City
Québec
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin
City
Angers
ZIP/Postal Code
49005
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Florence Lerebours
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
CHU de Nantes - Hôpital Nord Laennec
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Praxis für interdisziplinäre Onkologie & Hämatologie GbR
City
Freiburg im Breisgau
ZIP/Postal Code
79110
Country
Germany
Facility Name
Facharztzentrum Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Institut für Versorgungsforschung in der Onkologie
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Praxis für Hämatologie und Internistische Onkologie
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Hospital Teresa Herrera, As Xubias, 84
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quirón Barcelona, Plaza Alfonso Comín 5
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Facility Name
Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203
City
Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida
City
Lleida
ZIP/Postal Code
25195
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
City
Colchester
State/Province
ESS
ZIP/Postal Code
C04 5JL
Country
United Kingdom
Facility Name
The Arden Cancer Centre- University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham
City
Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
The Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
The County Hospital, Wye Valley NHS Trust
City
Hereford
ZIP/Postal Code
HR1 2BN
Country
United Kingdom
Facility Name
The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust - Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gileadclinicaltrials.com/transparency-policy/
Citations:
PubMed Identifier
30786188
Citation
Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.
Results Reference
background
Citation
Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
Results Reference
result
Citation
Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
Results Reference
result
Citation
Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
Results Reference
result
Citation
Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325
Results Reference
result
Citation
Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05
Results Reference
result
PubMed Identifier
35545724
Citation
O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortes J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11.
Results Reference
derived
PubMed Identifier
34467774
Citation
Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.
Results Reference
derived
PubMed Identifier
33882206
Citation
Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.
Results Reference
derived
PubMed Identifier
33093337
Citation
McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.
Results Reference
derived
PubMed Identifier
33070624
Citation
Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17.
Results Reference
derived
Learn more about this trial
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
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