Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574455
• Other study ID #: IMMU-132-05
• Secondary ID: 2017-003019-21
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2017
• Est. completion date: December 8, 2020

Study information

• Verified date: May 2022
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: December 8, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Sacituzumab govitecan
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.
• Eribulin
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).
• Capecitabine
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.
• Gemcitabine
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.
• Vinorelbine
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.

Locations

Country	Name	City	State
Belgium	Universitair Zlekenhuis Brussel	Brussels
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Leuven	Leuven
Belgium	Clinique et Maternite Sainte-Elisabeth	Namur
Canada	Cross Cancer Institute, 11560 University Avenue	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Jewish General Hospital, 3755 Côte-Sainte-Catherine	Montréal	Quebec
Canada	Jewish General Hospital, 3755 Côte-Sainte-Catherine	Québec	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
France	Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin	Angers
France	CHU Besançon - Hôpital Jean Minjoz	Besançon
France	Institut Régional du Cancer de Montpellier	Montpellier
France	Institut Curie	Paris
France	Centre Eugène Marquis	Rennes Cedex
France	Florence Lerebours	Saint-Cloud
France	CHU de Nantes - Hôpital Nord Laennec	Saint-Herblain
France	Institut Claudius Regaud	Toulouse
France	Gustave Roussy	Villejuif
Germany	Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus	Frankfurt
Germany	Praxis für interdisziplinäre Onkologie & Hämatologie GbR	Freiburg im Breisgau
Germany	Facharztzentrum Eppendorf	Hamburg
Germany	Institut für Versorgungsforschung in der Onkologie	Koblenz
Germany	Praxis für Hämatologie und Internistische Onkologie	Velbert
Spain	Hospital Teresa Herrera, As Xubias, 84	A Coruña
Spain	Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quirón Barcelona, Plaza Alfonso Comín 5	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203	Hospitalet de Llobregat
Spain	Hospital Universitari Arnau de Vilanova de Lleida	Lleida
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario	Santiago De Compostela
Spain	Hospital Universitario Virgen del Rocío	Sevilla
United Kingdom	Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road	Colchester	ESS
United Kingdom	The Arden Cancer Centre- University Hospital Coventry	Coventry
United Kingdom	County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham	Durham
United Kingdom	The Royal Surrey County Hospital NHS Foundation Trust	Guildford
United Kingdom	The County Hospital, Wye Valley NHS Trust	Hereford
United Kingdom	The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust - City Hospital	Nottingham
United Kingdom	Plymouth Hospitals NHS Trust - Derriford Hospital	Plymouth
United Kingdom	Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital	Taunton
United Kingdom	The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital	Wakefield
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Virginia Cancer Specialists, PC	Alexandria	Virginia
United States	UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200	Alhambra	California
United States	Atlanta Cancer Center - Alpharetta	Alpharetta	Georgia
United States	Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive	Altamonte Springs	Florida
United States	Center for Cancer and Blood Disorders	Arlington	Texas
United States	Virginia Cancer Specialists, PC	Arlington	Virginia
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	University Cancer & Blood Center, 3320 Old Jefferson Rd	Athens	Georgia
United States	Atlanta Cancer Care - Atlanta	Atlanta	Georgia
United States	GCS/Annex	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers, 1700 South Potomac Street	Aurora	Colorado
United States	University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court	Aurora	Colorado
United States	Maryland Oncology Hematology	Bethesda	Maryland
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Blacksburg	Virginia
United States	Florida Cancer Specialist	Bonita Springs	Florida
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers, 4715 Arapahoe Ave	Boulder	Colorado
United States	Florida Cancer Specialists	Bradenton	Florida
United States	Florida Cancer Specialists & Research Institute, 403 S. King Ave	Brandon	Florida
United States	Maryland Oncology Hematology	Brandywine	Maryland
United States	UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200	Burbank	California
United States	Center for Cancer and Blood Disorders	Burleson	Texas
United States	GCS/Canton	Canton	Georgia
United States	Florida Cancer Specialists	Cape Coral	Florida
United States	UNC Health Care System	Chapel Hill	North Carolina
United States	Tennesee Oncology - PLLC	Chattanooga	Tennessee
United States	Tennessee Oncology - Chattanooga Oncology & Hematology Associates	Chattanooga	Tennessee
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	University of Chicago Medical Center 5841 S. Maryland Ave	Chicago	Illinois
United States	Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road	Clearwater	Florida
United States	Tenesse Oncology - PLLC	Cleveland	Tennessee
United States	New York Oncology Hematology, P.C.	Clifton Park	New York
United States	Maryland Oncology Hematology	Clinton	Maryland
United States	Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400	Colorado Springs	Colorado
United States	Maryland Oncology Hematology	Columbia	Maryland
United States	The Ohio State University Wexner Medical Center, 1145 Olentangy River Road	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center, 460 W 10th Ave	Columbus	Ohio
United States	Atlanta Cancer Care - Conyers	Conyers	Georgia
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Minnesota Oncology Hematology P.A.	Coon Rapids	Minnesota
United States	Suburban Imaging	Coon Rapids	Minnesota
United States	Suburban Imaging Northwest	Coon Rapids	Minnesota
United States	Sylvester Comprehensive Cancer Center	Coral Gables	Florida
United States	Washington University School of Medicine in St. Louis	Creve Coeur	Missouri
United States	Atlanta Cancer Care - Cumming	Cumming	Georgia
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology- Medical City Dallas Building D	Dallas	Texas
United States	Mass General - North Shore Cancer Center ( NSCC )	Danvers	Massachusetts
United States	Southern Cancer Center, 29653 Anchor Cross Blvd	Daphne	Alabama
United States	Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway	Daytona Beach	Florida
United States	Atlanta Cancer Care - Decatur	Decatur	Georgia
United States	GCS/Stemmer	Decatur	Georgia
United States	Sylvester Comprehensive Cancer Center	Deerfield Beach	Florida
United States	Texas Oncology	Denton	Texas
United States	Rocky Mountain Cancer Centers, 1800 Williams St.	Denver	Colorado
United States	Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400	Denver	Colorado
United States	Tennessee Oncology, LLC	Dickson	Tennessee
United States	North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road	East Setauket	New York
United States	Swedish Cancer Institute	Edmonds	Washington
United States	Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450	Englewood	Colorado
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Tennessee Ocology, LLC	Franklin	Tennessee
United States	Mercy Hospital - Unity Campus AHL	Fridley	Minnesota
United States	Minnesota Oncology Hematology P.A.	Fridley	Minnesota
United States	Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing	Gainesville	Florida
United States	Virginia Cancer Specialists, PC	Gainesville	Virginia
United States	Tennessee Oncology, LLC	Gallatin	Tennessee
United States	West Cancer Center, 7945 Wolf River Blvd	Germantown	Tennessee
United States	UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion	Greensburg	Pennsylvania
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Tennessee Oncology, LLC	Hermitage	Tennessee
United States	Houston Methodist Hospital - 6565 Fannin St	Houston	Texas
United States	MidAmerica Division Inc. c/o Menorah Medical Center	Independence	Missouri
United States	Swedish Cancer Institute	Issaquah	Washington
United States	Atlanta Cancer Care - Stockbridge	Jonesboro	Georgia
United States	Research Medical Center	Kansas City	Missouri
United States	UCLA Jonsson Comprehensive Cancer Center	Laguna Hills	California
United States	Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100	Lakewood	Colorado
United States	Florida Cancer Specialists & Research Institute, 100 Highland Avenue	Largo	Florida
United States	Tennessee Oncology, LLC	Lebanon	Tennessee
United States	Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway	Lecanto	Florida
United States	Virginia Cancer Specialists, PC	Leesburg	Virginia
United States	Rocky Mountain Cancer Centers, 22 West Dry Creek Circle	Littleton	Colorado
United States	Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210	Longmont	Colorado
United States	Texas Oncology-Longview Cancer Center	Longview	Texas
United States	UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza	Los Angeles	California
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Low Moor	Virginia
United States	GCS/Macon	Macon	Georgia
United States	GCS/Kennestone	Marietta	Georgia
United States	Baptist Health Medical Group Oncology, LLC	Miami	Florida
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Abbot Northwestern Hospital	Minneapolis	Minnesota
United States	Minnesota Oncology Hematology P.A.	Minneapolis	Minnesota
United States	Virginia G. Piper Cancer Center at HonorHealth	Minneapolis	Minnesota
United States	Souther Cancer Center, 3719 Dauphin St., 5 Floor	Mobile	Alabama
United States	Southern Cancer Center, 3 Mobile Infirmary Circle	Mobile	Alabama
United States	Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level	Mobile	Alabama
United States	UPMC Hillman Cancer Center UPMC East	Monroeville	Pennsylvania
United States	Tennessee Oncology, LLC	Murfreesboro	Tennessee
United States	Florida Cancer Specialists	Naples	Florida
United States	Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232	Nashville	Tennessee
United States	Sarah Cannon Cancer Institute/Tennessee Oncology	Nashville	Tennessee
United States	Tenessee Oncology	Nashville	Tennessee
United States	Tennessee Ocology, LLC	Nashville	Tennessee
United States	Tennessee Oncology, LLC	Nashville	Tennessee
United States	Tennessee Oncology, LLC	Nashville	Tennessee
United States	Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale School Of Medicine	New Haven	Connecticut
United States	University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd	New Lenox	Illinois
United States	Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd	New Port Richey	Florida
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Virginia Oncology Associates, P.C.	Norfolk	Virginia
United States	Norwalk Hospital, 34 Maple Street	Norwalk	Connecticut
United States	Florida Cancer Specialists & Research Institute, 1630 SE 18th ST	Ocala	Florida
United States	Nebraska Cancer Specialists - Midwest Cancer Center - Paillion	Omaha	Nebraska
United States	Nebraska Cancer Specialists - Midwest Cancer Center - Papillion	Omaha	Nebraska
United States	Florida Cancer Specialists & Research Institute, 765 Image Way	Orange City	Florida
United States	Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd	Orland Park	Illinois
United States	Florida Cancer Specialists & Research Institute, 70 W Gore Street	Orlando	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Florida Cancer Specialists & Research Institute - 325 Clyde Morris	Ormond Beach	Florida
United States	MidAmerica Division Inc. c/o Menorah Medical Center	Overland Park	Kansas
United States	Nebraska Cancer Specialists- Midwest Cancer Center- Papillion	Papillion	Nebraska
United States	Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421	Parker	Colorado
United States	UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320	Pasadena	California
United States	North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16	Patchogue	New York
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Allegheny-Singer Research Institute, 320 East North Avenue	Pittsburgh	Pennsylvania
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center Upper Saint Clair	Pittsburgh	Pennsylvania
United States	Texas Oncology	Plano	Texas
United States	Sylvester Comprehensive Cancer Center	Plantation	Florida
United States	Florida Cancer Specialists	Port Charlotte	Florida
United States	Providence Medical Group	Portland	Oregon
United States	Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350	Pueblo	Colorado
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Roanoke	Virginia
United States	Mayo Clinic - 200 First Street SW	Rochester	Minnesota
United States	Maryland Oncology Hematology	Rockville	Maryland
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North	Saint Petersburg	Florida
United States	Florida Cancer Specialists & Research Institute, 560 Jackson St	Saint Petersburg	Florida
United States	Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Salem	Virginia
United States	University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street	San Francisco	California
United States	GCS/Northside	Sandy Springs	Georgia
United States	UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard	Santa Monica	California
United States	Florida Cancer Specialists	Sarasota	Florida
United States	Mayo Clinic Hospital	Scottsdale	Arizona
United States	Swedish Cancer Institute	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Tennessee Oncology, LLC	Shelbyville	Tennessee
United States	Maryland Oncology Hematology	Silver Spring	Maryland
United States	Maryland Oncology Hematology	Silver Spring	Maryland
United States	Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive	Spring Hill	Florida
United States	Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard	Tampa	Florida
United States	Florida Cancer Specialists & Research Institute, 4100 Waterman Way	Tavares	Florida
United States	Florida Cancer Specialists & Research Institute, 1400 US highway 441 N	The Villages	Florida
United States	Rocky Mountain Cancer Centers, 8820 Huron Street	Thornton	Colorado
United States	US Oncology	Tyler	Texas
United States	Florida Cancer Specialists	Venice	Florida
United States	Florida Cancer Specialists	Venice	Florida
United States	Florida Cancer Specialists & Research Institute - 3730 7th Terrace	Vero Beach	Florida
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia
United States	Center for Cancer and Blood Disorders	Weatherford	Texas
United States	Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B	Wellington	Florida
United States	Florida Cancer Specialists & Research Institute1309 N Flagler Dr	West Palm Beach	Florida
United States	University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion	Westwood	Kansas
United States	Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive	Winter Park	Florida
United States	Virginia Cancer Specialists, PC	Woodbridge	Virginia
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Spain,  United Kingdom, 

References & Publications (6)

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. — View 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

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 Oncolo

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 Cance

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; Decembe

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; De

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Secondary	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.	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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	First dose date up to last follow-up (maximum up to 30.8 months)
Secondary	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.	Baseline; End of Treatment (EOT) (up to 29.6 months)
Secondary	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.	First dose date up to last follow-up (maximum up to 30.8 months)