Study Details

OVERVIEW

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy (ASCENT-07)

PROTOCOL SUMMARY

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer

Gender

N/A

Date

May 2023 - September 2025

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel, Capecitabine

Eligibility Information

Inclusion Criteria

Able to understand and give written informed consent.
Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
Documented evidence of HER2- status.
Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
Candidate for the first chemotherapy in the locally advanced or metastatic setting.
Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
Individuals must have at least one of the following:
Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.
Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
Have an active second malignancy.
Have an active serious infection requiring antibiotics.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (170)

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Chandler, Arizona, United States, 85224

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States, 90017

Stanford Cancer Institute

Palo Alto, California, United States, 94305

University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94143

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado, United States, 80120

Yale-New Haven Hospital-Yale Cancer Center

New Haven, Connecticut, United States, 06510

Investigational Drug Services, AdventHealth Orlando

Altamonte Springs, Florida, United States, 32701

Florida Cancer Specialists

Brooksville, Florida, United States, 34613

Florida Cancer Specialist

Leesburg, Florida, United States, 34748

Florida Cancer Specialist

Saint Petersburg, Florida, United States, 33705

Piedmont Cancer Institute

Atlanta, Georgia, United States, 30318

Georgia Cancer Specialist - Annex

Atlanta, Georgia, United States, 30341

Northwest Georgia Oncology Centers

Marietta, Georgia, United States, 30060

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States, 70809

Saint Luke's Cancer Institute

Kansas City, Missouri, United States, 64110

David C. Pratt Cancer Center

Saint Louis, Missouri, United States, 63141

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Penn State Cancer Institute

Hershey, Pennsylvania, United States, 17033

Magee-Womens of UPMC

Pittsburgh, Pennsylvania, United States, 15213

Prisma Health - Upstate

Greenville, South Carolina, United States, 29605

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

US Oncology Investigational Products Center (IPC)

Fairfax, Virginia, United States, 22031

US Oncology Investigational Products Center (IPC)

Norfolk, Virginia, United States, 23502

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States, 98001

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina, 1426

Royal Brisbane and Women's Hospital

Queensland, ME, Australia, 4029

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

GenesisCare North Shore (Oncology)

St Leonards, New South Wales, Australia, 2065

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia, 4066

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia, 7000

Austin Health

Melbourne, Victoria, Australia, 3084

Sunshine Hospital (Western Health)

St Albans, Victoria, Australia, 3021

University Hospital Innsbruck

Innsbruck, Austria, 06020

Universitätsklinik für Innere Medizin 3 der PMU

Salzburg, Austria, A-5020

Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie

Wien, Austria, 1090

GZA Ziekenhuizen - Campus Sint-Augustinus

Antwerpen, Belgium, 2610

AZ Klina

Brasschaat, Belgium, 2930

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Universitaire Ziekenhuis Leuven

Leuven, Belgium, 3000

CHU UCL Namur-Site STE. Elisabeth

Namur, Belgium, 5000

HGB - Hospital Giovanni Battista/Mãe de Deus Center

Porto Alegre, Brazil, 90110-270

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo Andre, Brazil, 09060-650

BC Cancer - Kelowna

Kelowna, Canada, V1Y 5L3

The Ottawa Hospital Cancer Centre

Ottawa, Canada, K1H 8L6

CHU de Québec-Université Laval, Hôpital du Saint-Sacrement

Quebec, Canada, G1S 4L8

BC Cancer-Victoria

Victoria, Canada, V8R 6V5

Centro de Investigacion Clinica Bradford Hill

Recoleta, Chile

Centro del Cancer UC

Region Metropolitana, Chile, 7550000

Centro de Oncología de Precisión, Universidad Mayor

Santiago Region, Chile, 8330032

James Lind Centro de Investigacion del Cancer

Temuco, Chile

Oncocentro APYS

Vina del Mar, Chile, 2520612

West China Hospital Sichuan University

Chengdu, China, 610041

Sun Yat-Sen University Cancer Center

Guangdong, China, 510060

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

Hangzhou, China, 310000

Zhejiang Cancer Hospital

Hangzhou, China, 310022

Harbin Medical University Cancer Hospital

Heilongjiang, China, 150081

The Nanchang Third Hospital

Jiangxi, China, 330009

The Second Hospital of Jilin University

Jilin Sheng, China, 130041

Fudan University Shanghai Cancer Center

Shanghai, China, 200030

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China, 453000

Hubei Cancer Hospital

Wuhan, China, 430079

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China, 310009

Masaryk Memorial Cancer Institute

Brno, Czechia, 656 53

University Hospital Olomouc

Olomouc, Czechia, 779 00

Multiscan s.r.o

Pardubice, Czechia, 532 01

Krajska nemocnice Tomase Bati Zlin

Zlin, Czechia, 760 01

CHU Jean Minjoz

Besancon, France, 25030

Centre Georges François Leclerc

Dijon, France, 21000

Ico René Gauducheau

Loire Atlantique, France, 44 805

Institut Paoli Calmettes

Marseille, France, 13009

Institut Regional du Cancer de Montpellier

Montpellier Cedex 5, France, 34298

Institut Curie

Paris, France, 75248

Centre Hospitalier Lyon-Sud

Pierre-benite, France, 69310

Hopital Privé des Cotes d'Armor

Plerin, France, 22190

Centre Jean Bernard Service d'Oncologie Médicale

Rennes Cedex, France, 35042

Centre Henri Becquerel

Rouen, France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse Cedex 9, France, 31059

Universitäts - Frauenklinik

Tübingen, Germany, 72076

Alexandra General Hospital

Athens, Greece, 11528

Attikon Hospital

Athens, Greece, 124 62

University Hospital of Heraklion

Heraklion, Greece

University Hospital of Patras

Patras, Greece, 26 500

Bioclinic of Thessaloniki

Thessaloniki, Greece, 546 22

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece, 546 45

Hong Kong Integrated Oncology Centre

Hong Kong, Hong Kong, 0

Prince of Wales Hospital

New Territories, Hong Kong

Queen Mary Hospital

Pok Fu Lam, Hong Kong, 0

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary, 4032

Oncology Institute Rambam Health Care Campus

Haifa, Israel, 31096

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Hadassah Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel, 52621

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona AN, Italy, 60126

Humanitas Gavazzeni

Bergamo, Italy, 24125

Humanitas Istituto Clinico Catanese

Catania, Italy, 95045

Azienda Ospedaliera Mater Domini

Catanzaro, Italy, 88100

Istituto Europeo di Oncologia

Milan, Italy, 20141

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, Italy, 80131

Irccs Crob

Rionero in Vulture, Italy, 85028

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, Italy, 161

Aichi Cancer Center Hospital

Aichi, Japan, 464-8681

Tohoku University Hospital

Aoba-ku, Japan, 980-8574

Juntendo University Hospital

Bunkyo-ku, Japan, 113-8431

Chiba Cancer Center

Chiba, Japan, 260-8717

National Cancer Center Hospital

Chuo-ku, Japan, 1040045

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Chuo-ku, Japan, 541-8567

National Hospital Organization Shikoku Cancer Center

Ehime, Japan, 791-0280

Fukushima Medical University Hospital

Fukushima, Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima-shi, Japan, 892-0833

Tokai University Hospital

Kanagawa, Japan, 259-1193

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Saitama Cancer Center

Kitaadachi-gun, Japan, 362-0806

Cancer Institute Hospital of JFCR

Koto-Ku, Japan, 135-8550

Kumamoto University Hospital

Kumamoto- shi, Japan, 860-8556

Kyoto University Hospital

Kyoto-shi, Japan, 606-8507

National Hospital Organization Kyushu Cancer Center

Minami-ku, Japan, 811-1395

Nagoya University Hospital

Nagoya, Japan, 466-8560

Hiroshima City Hiroshima Citizens Hospital

Naka-ku, Japan, 730-8518

Hyogo Medical University Hospital

Nishinomiya-shi, Japan, 663-8501

Okayama University Hospital

Okayama, Japan, 700-8558

Gunma Prefectural Cancer Center

Ota, Japan, 373-8550

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Japan, 162-8655

Showa University Hospital

Tokyo, Japan, 142-8555

Kanagawa Cancer Center

Yokohama, Japan, 241-8515

Samsung Medical Center

Gangnam-Gu, Korea, Republic of, 06351

National Cancer Center

Goyang-si Gyeonggi-do, Korea, Republic of, 10408

Kyungpook National University Chilgok Hospital

Gyeongsangbuk-do, Korea, Republic of, 41404

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 21565

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of, 13620

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o

Krakow, Poland, 31-826

Instytut MSF Sp. z o.o.

Lodz, Poland, 90-302

Maria Sklodowska - Curie Institute of Oncology

Warszawa, Poland, 02-781

Centro Clinico Academico - Hospital de Braga

Braga, Portugal

National Cancer Centre Singapore

Singapore, Singapore, 169610

Tan Tock Seng Hospital

Singapore, Singapore, 308433

The Medical Oncology Centre of Rosebank

Johannesburg, South Africa, 2196

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 8035

Hospital Universitario Reina Sofia

Córdoba, Spain, 14004

Hospital General Universitario De Elche

Elche, Spain, 3203

Hospital Universitario de Jaen

Jaen, Spain, 23007

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Hospital Clinico San Carlos

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Clínico Universitario de Santiago de Compostela - CHUS

Santiago de Compostela, Spain, 15706

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41071

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Instituto Valenciano De Oncologia (IVO)

Valencia, Spain, 46009

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 83301

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan, 235

Chi Mei Hospital, Liouying

Tainan City, Taiwan, 73657

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Taipei Veterans General Hospital

Taipei City, Taiwan, 11217

National Taiwan University Hospital

Taipei, Taiwan, 10048

Tri-Service General Hospital

Taipei, Taiwan, 11490

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 999999

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan, 33305

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW10 9NH

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy (ASCENT-07)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (170)

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Los Angeles Hematology Oncology Medical Group

Stanford Cancer Institute

University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

Rocky Mountain Cancer Centers, LLP

Yale-New Haven Hospital-Yale Cancer Center

Investigational Drug Services, AdventHealth Orlando

Florida Cancer Specialists

Florida Cancer Specialist

Florida Cancer Specialist

Piedmont Cancer Institute

Georgia Cancer Specialist - Annex

Northwest Georgia Oncology Centers

The University of Kansas Hospital

Hematology Oncology Clinic

Saint Luke's Cancer Institute

David C. Pratt Cancer Center

Astera Cancer Care

Rutgers Cancer Institute of New Jersey

Cleveland Clinic

Penn State Cancer Institute

Magee-Womens of UPMC

Prisma Health - Upstate

Tennessee Oncology, PLLC

US Oncology Investigational Products Center (IPC)

US Oncology Investigational Products Center (IPC)

MultiCare Regional Cancer Center - Auburn

Hospital Britanico de Buenos Aires

Royal Brisbane and Women's Hospital

St Vincent's Hospital Sydney

GenesisCare North Shore (Oncology)

Icon Cancer Centre Wesley

Icon Cancer Centre Hobart

Austin Health

Sunshine Hospital (Western Health)

University Hospital Innsbruck

Universitätsklinik für Innere Medizin 3 der PMU

Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie

GZA Ziekenhuizen - Campus Sint-Augustinus

AZ Klina

Cliniques Universitaires Saint-Luc

Universitaire Ziekenhuis Leuven

CHU UCL Namur-Site STE. Elisabeth

HGB - Hospital Giovanni Battista/Mãe de Deus Center

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

BC Cancer - Kelowna

The Ottawa Hospital Cancer Centre

CHU de Québec-Université Laval, Hôpital du Saint-Sacrement

BC Cancer-Victoria

Centro de Investigacion Clinica Bradford Hill

Centro del Cancer UC

Centro de Oncología de Precisión, Universidad Mayor

James Lind Centro de Investigacion del Cancer

Oncocentro APYS

West China Hospital Sichuan University

Sun Yat-Sen University Cancer Center

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

Zhejiang Cancer Hospital

Harbin Medical University Cancer Hospital

The Nanchang Third Hospital

The Second Hospital of Jilin University

Fudan University Shanghai Cancer Center

Tianjin Medical University Cancer Institute & Hospital

Hubei Cancer Hospital

The First Affiliated Hospital of Xi'an Jiaotong University

The Second Affiliated Hospital of Zhejiang University School of Medicine

Masaryk Memorial Cancer Institute

University Hospital Olomouc

Multiscan s.r.o

Krajska nemocnice Tomase Bati Zlin