Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
Launched by GILEAD SCIENCES · May 16, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called sacituzumab govitecan-hziy (SG) for patients with locally advanced or metastatic triple-negative breast cancer (TNBC) that has not been treated before. The goal is to see if SG can help patients live longer without their cancer getting worse compared to other standard treatments chosen by their doctors. This study is specifically looking at patients whose tumors do not express a protein called PD-L1, which can affect how their cancer responds to certain therapies.
To be eligible for this trial, participants need to have a confirmed diagnosis of previously untreated TNBC, and their tumors must be tested for the PD-L1 protein. They should also have measurable cancer that can be evaluated using imaging tests like CT or MRI. Participants must be in good overall health, and both men and women can join, although women who are pregnant or breastfeeding cannot participate. If eligible, patients can expect to receive either the new treatment or the standard treatment from their doctor, and their health will be closely monitored throughout the study. This trial is currently recruiting participants, offering a chance to be part of important research that could help improve future breast cancer treatments.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- • Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
- • Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- • Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
- • Individuals presenting with de novo metastatic TNBC are eligible
- • Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
- • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- • Demonstrates adequate organ function
- • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- • Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
- Key Exclusion Criteria:
- • Positive serum pregnancy test or women who are lactating
- • Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- • Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- • May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- • Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- • Active second malignancy
- • Active serious infection requiring antibiotics
- • Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Boston, Massachusetts, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Brussels, , Belgium
Edmonton, , Canada
Toronto, , Canada
Edmonton, Alberta, Canada
Chicago, Illinois, United States
Madrid, , Spain
Fort Myers, Florida, United States
Hong Kong, , Hong Kong
Norwich, Connecticut, United States
Malaga, , Spain
Boston, Massachusetts, United States
Murcia, , Spain
Pretoria, , South Africa
Singapore, , Singapore
Villejuif, , France
Milan, , Italy
Barcelona, , Spain
Norfolk, Virginia, United States
Baltimore, Maryland, United States
Anchorage, Alaska, United States
Philadelphia, Pennsylvania, United States
Woolloongabba, Queensland, Australia
Atlanta, Georgia, United States
North Sydney, New South Wales, Australia
Tel Aviv, , Israel
East Syracuse, New York, United States
Changhua, , Taiwan
Nashville, Tennessee, United States
Hamburg, , Germany
Clayton, Victoria, Australia
Pittsburgh, Pennsylvania, United States
Baden, Aargau, Switzerland
Taipei, , Taiwan
Valencia, , Spain
Gent, , Belgium
Okayama, , Japan
Fukushima, , Japan
Taichung, , Taiwan
Leeuwarden, , Netherlands
Villejuif, , France
Melbourne, Victoria, Australia
Taichung, , Taiwan
Clermont Ferrand, , France
Seoul, , Korea, Republic Of
Caen, , France
Tübingen, , Germany
Hong Kong, , Hong Kong
Leuven, , Belgium
Seoul, , Korea, Republic Of
Jerusalem, , Israel
Barcelona, , Spain
Groningen, , Netherlands
Barcelona, , Spain
Albury, New South Wales, Australia
Beijing, , China
Lleida, , Spain
Rotterdam, , Netherlands
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Tel Aviv, , Israel
Taipei, , Taiwan
Seoul, , Korea, Republic Of
Shizuoka, , Japan
Guangzhou, Guangdong, China
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Brussels, , Belgium
Nagoya, Aichi, Japan
Winterthur, , Switzerland
Aichi, , Japan
Kanagawa, , Japan
Rotterdam, , Netherlands
Mie, , Japan
Santa Barbara, California, United States
Chengdu, , China
New Brunswick, New Jersey, United States
Fukushima, , Japan
Tenerife, , Spain
Boulder, Colorado, United States
Berlin, , Germany
Salzburg, , Austria
Dallas, Texas, United States
Guangzhou, Guangdong, China
Sevilla, , Spain
Harbin, , China
Jerusalem, , Israel
Barcelona, , Spain
Westwood, Kansas, United States
London, , United Kingdom
Seoul, Songpa Gu, Korea, Republic Of
Rennes Cedex, , France
Baden, , Switzerland
Chicago, Illinois, United States
Sarawak, , Malaysia
Houston, Texas, United States
Kashiwa, , Japan
Changsha, Hunan, China
Caen, , France
Montpellier, , France
Barcelona, Cataluña, Spain
Wien, , Austria
Prague, , Czechia
Seoul, , Korea, Republic Of
Fort Lauderdale, Florida, United States
Barcelona, , Spain
Chengdu, , China
Sevilla, , Spain
Beijing, , China
Beijing, Beijing, China
Cluj Napoca, , Romania
Rehovot, , Israel
Tainan City, , Taiwan
Leeds, , United Kingdom
Omaha, Nebraska, United States
Sakyo Ku, , Japan
Suita, , Japan
Wiener Neustadt, , Austria
Haifa, , Israel
Jinan, Shandong, China
Kfar Saba, , Israel
Southfield, Michigan, United States
Brasschaat, , Belgium
Sabah, , Malaysia
Gdansk, , Poland
Jinan, Shandong, China
Hilton, , South Africa
Johor Bahru, , Malaysia
Graz, , Austria
Nantes, , France
London, , Canada
Skokie, Illinois, United States
Singapore, , Singapore
Bunkyo Ku, , Japan
Seoul, , Korea, Republic Of
St. Gallen, , Switzerland
Nagoya, , Japan
London, , United Kingdom
Xi'an, Shanxi, China
Kuala Lumpur, , Malaysia
Columbus, Ohio, United States
Tokyo, , Japan
Madrid, , Spain
Xi'an, , China
Madrid, , Spain
Chongqing, , China
Hamburg, , Germany
Pretoria, Gauteng, South Africa
Linz, , Austria
Edirne, , Turkey
Petah Tikva, , Israel
Istanbul, , Turkey
Zürich, , Switzerland
Porto Alegre, Rio Grande Do Sul, Brazil
Padova, , Italy
Koto Ku, , Japan
Ehime, , Japan
Seoul, , Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Debrecen, , Hungary
London, , United Kingdom
Hualien City, , Taiwan
Chengdu, , China
Changhua, , Taiwan
Wuhan, Hubei, China
Hefei, Anhui, China
Warsaw, , Poland
Tucson, Arizona, United States
Torrance, California, United States
Beer Sheva, , Israel
Roma, , Italy
San Antonio, Texas, United States
Nagoya, , Japan
San Juan, , Puerto Rico
Cheltenham, , United Kingdom
Wuhan, Hubei, China
Sapporo, , Japan
Mönchengladbach, , Germany
Los Alamitos, California, United States
Jonesboro, Arkansas, United States
Ota, , Japan
Goyang Si Gyeonggi Do, , Korea, Republic Of
Montréal, , Canada
Milano, , Italy
Putrajaya, , Malaysia
Wuhan, , China
Niigata Shi, , Japan
Salzburg, , Austria
Yokohama, , Japan
West Palm Beach, Florida, United States
Louisville, Kentucky, United States
Hefei, , China
Kaohsiung City, , Taiwan
Hefei, , China
Nanning, , China
Singapore, , Singapore
Hobart, Tasmania, Australia
Chongqing, Chongqing, China
Toulouse, , France
Hot Springs, Arkansas, United States
London, , Canada
St Leonards, New South Wales, Australia
Kuala Lumpur, , Malaysia
Ponce, , Puerto Rico
Grosse Pointe Woods, Michigan, United States
Taoyuan City, , Taiwan
Kogarah, New South Wales, Australia
Wuhan, , China
Providencia, , Chile
Ijui, , Brazil
Montreal, , Canada
Aoba Ku, , Japan
Kumamoto Shi, , Japan
Adelaide, South Australia, Australia
A Coruña, , Spain
Taipei, , Taiwan
Baton Rouge, Louisiana, United States
Denison, Texas, United States
Altamonte Springs, Florida, United States
Saint Petersburg, Florida, United States
Florham Park, New Jersey, United States
Tigard, Oregon, United States
Austin, Texas, United States
Richmond, Virginia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Liestal, , Switzerland
Hong Kong, , Hong Kong
Georgetown, , Malaysia
Germantown, Tennessee, United States
Sariyer, , Turkey
Pennington, New Jersey, United States
Winston Salem, North Carolina, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Solvang, California, United States
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Avignon, , France
Besancon, , France
Brest, , France
Plerin, , France
Rome, , Italy
Zapopan, , Mexico
Johannesburg, , South Africa
Sevilla, , Spain
Hot Springs, Arkansas, United States
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Portland, Oregon, United States
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Fort Worth, Texas, United States
Weatherford, Texas, United States
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Richmond, Virginia, United States
Vancouver, Washington, United States
Pierre Benite, , France
München, , Germany
Ciudad De Mexico, , Mexico
Culiacan, , Mexico
Guadalajara, , Mexico
Merida, , Mexico
San Luis Potosi, , Mexico
Veracruz, , Mexico
Breda, , Netherlands
Colorado Springs, Colorado, United States
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Denver, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Longmont, Colorado, United States
Pueblo, Colorado, United States
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Overland Park, Kansas, United States
Overland Park, Kansas, United States
Overland Park, Kansas, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
New York, New York, United States
Namur, , Belgium
Kure, , Japan
Shizuoka City, , Japan
Winter Park, Florida, United States
Freiburg, , Germany
Heidelberg, , Germany
Chuo Ku, , Japan
Maastricht, , Netherlands
Bratislava, , Slovakia
Innsbruck, , Austria
Sankt Poelten, , Austria
Charleroi, , Belgium
Halifax, , Canada
Ottawa, , Canada
Toronto, , Canada
Hradec Kralove, , Czechia
New Territories, , Hong Kong
Tel Aviv, , Israel
Viedma, , Argentina
Mechanicsburg, Pennsylvania, United States
Edmonds, Washington, United States
Issaquah, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Itajai, , Brazil
Jau, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Santiago, , Chile
Temuco, , Chile
Jerusalem, , Israel
Siena, , Italy
Minami Ku, , Japan
Chihuahua, , Mexico
Partizánske, , Slovakia
London, , United Kingdom
Chongqing, , China
Chicago, Illinois, United States
Danvers, Massachusetts, United States
York, Pennsylvania, United States
South Brisbane, Queensland, Australia
Olomouc, , Czechia
Köln, , Germany
Mannheim, , Germany
Brescia, , Italy
México, , Mexico
Bilbo, , Spain
Paragould, Arkansas, United States
Capital, , Argentina
Goiânia, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Salvador, , Brazil
Santo Andre, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Rimouski, , Canada
Santiago De Chile, , Chile
Santiago Region, , Chile
Santiago, , Chile
Praha, , Czechia
Bonn, , Germany
Essen, , Germany
Wiesbaden, , Germany
Gyor, , Hungary
Monterrey, , Mexico
Siedlce, , Poland
Bucharest, , Romania
Timisoara, , Romania
Košice, , Slovakia
Stockbridge, Georgia, United States
Dekalb, Illinois, United States
Dekalb, Illinois, United States
Geneva, Illinois, United States
Geneva, Illinois, United States
Lake Forest, Illinois, United States
Warrenville, Illinois, United States
Warrenville, Illinois, United States
Winfield, Illinois, United States
Bronx, New York, United States
São Paulo, , Brazil
Kitchener, , Canada
Vancouver, , Canada
Lecco, , Italy
Inamachi, , Japan
Kagoshima Shi, , Japan
Pensacola, Florida, United States
Santa Rosa Beach, Florida, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
San Miguel De Tucumán, , Argentina
Rio De Janeiro, , Brazil
Budapest, , Hungary
Napoli, , Italy
Cluj Napoca, , Romania
Craiova, , Romania
Bratislava, , Slovakia
Glasgow, , United Kingdom
Baltimore, Maryland, United States
Erie, Pennsylvania, United States
Erie, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Buenos Aires, , Argentina
Lübeck, , Germany
Hiroshima, , Japan
Naka Ku, , Japan
Poznan, , Poland
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Caba, , Argentina
Rosario, , Argentina
Hradec Králové, , Czechia
Bari, , Italy
Monza, , Italy
Novara, , Italy
Prato, , Italy
Chiba, , Japan
Ankara, , Turkey
La Jolla, California, United States
Longmont, Colorado, United States
Newton, Massachusetts, United States
Bologna, , Italy
Lucca, , Italy
Chuo Ku, , Japan
Opole, , Poland
Bradenton, Florida, United States
Brno, , Czechia
Wiesbaden, , Germany
Genova Ge, , Italy
Minami Ku, , Japan
Johannesburg, , South Africa
New Taipei City, , Taiwan
Tainan City, , Taiwan
Zachary, Louisiana, United States
Gliwice, , Poland
Adana, , Turkey
Ankara, , Turkey
İzmir, , Turkey
Pensacola, Florida, United States
Santa Rosa Beach, Florida, United States
Jamaica, New York, United States
Pok Fu Lam, , Hong Kong
Izmir, , Turkey
Erlangen, , Germany
Munster, , Germany
München, , Germany
Warszawa, , Poland
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Altamonte Springs, Florida, United States
Orange City, Florida, United States
Sisli, , Turkey
Zhejiang, , China
Macerata, , Italy
Jilin Sheng, , China
Oak Park, Illinois, United States
Jinan, , China
Grand Island, Nebraska, United States
Hangzhou, , China
Nanchang, , China
Zhejiang, , China
Taipei, , Taiwan
Kuala Lumpur, , Malaysia
Nashville, Tennessee, United States
Beijing, , China
Deyang, , China
London, , United Kingdom
Itajai, , Brazil
Montréal, , Canada
Tianjin, , China
Weihai, , China
Barcelona, , Spain
Fukushima, , Japan
Sao Paolo, , Brazil
Patients applied
Trial Officials
Gilead Study Director
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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