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)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stage IV Breast Cancer; Locally Advanced or Unresectable Metastatic Breast Cancer
• Intervention / Treatment: Drug: Sacituzumab Govitecan-hziy; Drug: Paclitaxel; Drug: Capecitabine; Drug: Nab-paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 654
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Recruiting
    • Hospital Britanico de Buenos Aires
• Australia
  • ME
    • Queensland, ME, Australia, 4029
      • Recruiting
      • Royal Brisbane and Women'S Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent'S Hospital Sydney
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • GenesisCare North Shore (Oncology)
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Recruiting
      • Icon Cancer Centre Wesley
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Icon Cancer Centre Hobart
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
    • St Albans, Victoria, Australia, 3021
      • Recruiting
      • Sunshine Hospital (Western Health)
• Austria
  • Innsbruck, Austria, 06020
    • Recruiting
    • University Hospital Innsbruck
  • Salzburg, Austria, A-5020
    • Recruiting
    • Universitätsklinik für Innere Medizin 3 der PMU
  • Wien, Austria, 1090
    • Recruiting
    • Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
• Belgium
  • Antwerpen, Belgium, 2610
    • Recruiting
    • GZA Ziekenhuizen - Campus Sint-Augustinus
  • Brasschaat, Belgium, 2930
    • Recruiting
    • AZ Klina
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitaire Ziekenhuis Leuven
  • Namur, Belgium, 5000
    • Recruiting
    • CHU UCL Namur-Site STE. Elisabeth
• Brazil
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • HGB - Hospital Giovanni Battista/Mãe de Deus Center
  • Santo Andre, Brazil, 09060-650
    • Recruiting
    • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
• Canada
  • Kelowna, Canada, V1Y 5L3
    • Recruiting
    • BC Cancer - Kelowna
  • Ottawa, Canada, K1H 8L6
    • Recruiting
    • The Ottawa Hospital Cancer Centre
  • Quebec, Canada, G1S 4L8
    • Recruiting
    • CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
  • Victoria, Canada, V8R 6V5
    • Recruiting
    • BC Cancer-Victoria
• Chile
  • Recoleta, Chile
    • Recruiting
    • Centro de Investigacion Clinica Bradford Hill
  • Region Metropolitana, Chile, 7550000
    • Recruiting
    • Centro del Cancer UC
  • Santiago Region, Chile, 8330032
    • Recruiting
    • Centro de Oncologia de Precision, Universidad Mayor
  • Temuco, Chile
    • Recruiting
    • James Lind Centro de Investigacion Del Cancer
  • Vina del Mar, Chile, 2520612
    • Recruiting
    • Oncocentro APYS
• China
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital Sichuan University
  • Guangdong, China, 510060
    • Recruiting
    • Sun Yat-Sen University Cancer Center
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310000
    • Recruiting
    • Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine
  • Heilongjiang, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Jiangxi, China, 330009
    • Recruiting
    • The Nanchang Third Hospital
  • Jilin Sheng, China, 130041
    • Recruiting
    • The Second Hospital of Jilin University
  • Shanghai, China, 200030
    • Recruiting
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 453000
    • Recruiting
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China, 430079
    • Recruiting
    • Hubei Cancer Hospital
  • Xi'an, China, 710061
    • Recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhejiang, China, 310009
    • Recruiting
    • The second affiliated hospital of zhejiang university school of medicine
• Czechia
  • Brno, Czechia, 656 53
    • Recruiting
    • Masaryk Memorial Cancer Institute
  • Olomouc, Czechia, 779 00
    • Recruiting
    • University Hospital Olomouc
  • Pardubice, Czechia, 532 01
    • Recruiting
    • Multiscan s.r.o
  • Zlin, Czechia, 760 01
    • Recruiting
    • Krajska nemocnice Tomase Bati Zlin
• France
  • Besancon, France, 25030
    • Recruiting
    • CHU Jean Minjoz
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges François Leclerc
  • Loire Atlantique, France, 44 805
    • Recruiting
    • ICO René Gauducheau
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Montpellier Cedex 5, France, 34298
    • Recruiting
    • Institut Regional du Cancer de Montpellier
  • Paris, France, 75248
    • Recruiting
    • Institut Curie
  • Pierre-benite, France, 69310
    • Recruiting
    • Centre hospitalier Lyon-Sud
  • Plerin, France, 22190
    • Recruiting
    • Hôpital Privé des Côtes d'Armor
  • Rennes Cedex, France, 35042
    • Recruiting
    • Centre Jean Bernard Service d'Oncologie Médicale
  • Rouen, France
    • Recruiting
    • Centre Henri Becquerel
  • Toulouse Cedex 9, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse Oncopole
• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitäts - Frauenklinik
• Greece
  • Athens, Greece, 11528
    • Recruiting
    • Alexandra General Hospital
  • Athens, Greece, 124 62
    • Recruiting
    • Attikon Hospital
  • Heraklion, Greece
    • Recruiting
    • University Hospital of Heraklion
  • Patras, Greece, 26 500
    • Recruiting
    • University Hospital of Patras
  • Thessaloniki, Greece, 546 22
    • Recruiting
    • Bioclinic of Thessaloniki
  • Thessaloniki, Greece, 546 45
    • Recruiting
    • Euromedica General Clinic of Thessaloniki
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong Integrated Oncology Centre
  • New Territories, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
  • Pok Fu Lam, Hong Kong
    • Recruiting
    • Queen Mary Hospital
• Hungary
  • Debrecen, Hungary, 4032
    • Recruiting
    • Debreceni Egyetem Klinikai Kozpont
• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Oncology Institute Rambam Health Care Campus
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Center
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Ancona AN, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Bergamo, Italy, 24125
    • Recruiting
    • Humanitas Gavazzeni
  • Catania, Italy, 95045
    • Recruiting
    • Humanitas Istituto Clinico Catanese
  • Catanzaro, Italy, 88100
    • Recruiting
    • Azienda Ospedaliera Mater Domini
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo Di Oncologia
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
  • Rionero in Vulture, Italy, 85028
    • Recruiting
    • Irccs Crob
  • Roma, Italy, 161
    • Recruiting
    • Azienda Ospedaliero-Universitaria Policlinico Umberto I
• Japan
  • Aichi, Japan, 464-8681
    • Recruiting
    • Aichi Cancer Center Hospital
  • Aoba-ku, Japan, 980-8574
    • Recruiting
    • Tohoku University Hospital
  • Bunkyo-ku, Japan, 113-8431
    • Recruiting
    • Juntendo University Hospital
  • Chiba, Japan, 260-8717
    • Recruiting
    • Chiba Cancer Center
  • Chuo-ku, Japan, 541-8567
    • Recruiting
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Chuo-ku, Japan, 1040045
    • Recruiting
    • National Cancer Center Hospital
  • Ehime, Japan, 791-0280
    • Recruiting
    • National Hospital Organization Shikoku Cancer Center
  • Fukushima, Japan
    • Recruiting
    • Fukushima Medical University Hospital
  • Kagoshima-shi, Japan, 892-0833
    • Recruiting
    • Social Medical Corporation Hakuaikai Sagara Hospital
  • Kanagawa, Japan, 259-1193
    • Recruiting
    • Tokai University Hospital
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • National Cancer Center Hospital East
  • Kitaadachi-gun, Japan, 362-0806
    • Recruiting
    • Saitama Cancer Center
  • Koto-Ku, Japan, 135-8550
    • Recruiting
    • Cancer Institute Hospital of JFCR
  • Kumamoto- shi, Japan, 860-8556
    • Recruiting
    • Kumamoto University Hospital
  • Kyoto-shi, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
  • Minami-ku, Japan, 811-1395
    • Recruiting
    • National Hospital Organization Kyushu Cancer Center
  • Nagoya, Japan, 466-8560
    • Recruiting
    • Nagoya University Hospital
  • Naka-ku, Japan, 730-8518
    • Recruiting
    • Hiroshima City Hiroshima Citizens Hospital
  • Nishinomiya-shi, Japan, 663-8501
    • Recruiting
    • Hyogo Medical University Hospital
  • Okayama, Japan, 700-8558
    • Recruiting
    • Okayama University Hospital
  • Ota, Japan, 373-8550
    • Recruiting
    • Gunma Prefectural Cancer Center
  • Sapporo, Japan, 003-0804
    • Recruiting
    • National Hospital Organization Hokkaido Cancer Center
  • Shinjuku-ku, Japan, 162-8655
    • Recruiting
    • Center Hospital of the National Center for Global Health and Medicine
  • Tokyo, Japan, 142-8555
    • Recruiting
    • Showa University Hospital
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Kanagawa Cancer Center
• Korea, Republic of
  • Gangnam-Gu, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Goyang-si Gyeonggi-do, Korea, Republic of, 10408
    • Recruiting
    • National Cancer Center
  • Gyeongsangbuk-do, Korea, Republic of, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Incheon, Korea, Republic of, 21565
    • Recruiting
    • Gachon University Gil Medical Center
  • Seongnam, Korea, Republic of, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
• Poland
  • Krakow, Poland, 31-826
    • Recruiting
    • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
  • Lodz, Poland, 90-302
    • Recruiting
    • Instytut MSF Sp. z o.o.
  • Warszawa, Poland, 02-781
    • Recruiting
    • Maria Sklodowska - Curie Institute of Oncology
• Portugal
  • Braga, Portugal
    • Recruiting
    • Centro Clinico Academico - Hospital de Braga
• Singapore
  • Singapore, Singapore, 169610
    • Recruiting
    • National Cancer Centre Singapore
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
• South Africa
  • Johannesburg, South Africa, 2196
    • Recruiting
    • The Medical Oncology Centre of Rosebank
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 8035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Elche, Spain, 3203
    • Recruiting
    • Hospital General Universitario de Elche
  • Jaen, Spain, 23007
    • Recruiting
    • Hospital Universitario de Jaén
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hospital Clínico Universitario de Santiago de Compostela - CHUS
  • Sevilla, Spain, 41071
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46009
    • Recruiting
    • Instituto Valenciano de Oncología (IVO)
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 235
    • Recruiting
    • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Tainan City, Taiwan, 73657
    • Recruiting
    • Chi Mei Hospital, Liouying
  • Taipei, Taiwan, 10048
    • Recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11490
    • Recruiting
    • Tri-Service General Hospital
  • Taipei, Taiwan, 999999
    • Recruiting
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei City, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 33305
    • Recruiting
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Recruiting
    • The Royal Marsden NHS Foundation Trust
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • California
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Los Angeles Hematology Oncology Medical Group
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford Cancer Institute
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Recruiting
      • Rocky Mountain Cancer Centers, LLP
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale-New Haven Hospital-Yale Cancer Center
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Recruiting
      • Investigational Drug Services, AdventHealth Orlando
    • Brooksville, Florida, United States, 34613
      • Recruiting
      • Florida Cancer Specialists
    • Leesburg, Florida, United States, 34748
      • Recruiting
      • Florida Cancer Specialist
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • Florida Cancer Specialist
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Recruiting
      • Piedmont Cancer Institute
    • Atlanta, Georgia, United States, 30341
      • Recruiting
      • Georgia Cancer Specialist - Annex
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Northwest Georgia Oncology Centers
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Hematology Oncology Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64110
      • Recruiting
      • Saint Luke's Cancer Institute
    • Saint Louis, Missouri, United States, 63141
      • Recruiting
      • David C. Pratt Cancer Center
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Cancer Institute
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Magee-Womens of UPMC
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health - Upstate
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, PLLC
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • US Oncology Investigational Products Center (IPC)
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • US Oncology Investigational Products Center (IPC)
  • Washington
    • Auburn, Washington, United States, 98001
      • Recruiting
      • MultiCare Regional Cancer Center - Auburn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy (SG); Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132; Trodelvy™
Active Comparator: Treatment of Physician's Choice (TPC); Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.; nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.; capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.	Drug: Paclitaxel; Administered intravenously; Other Names: Taxol®; Drug: Capecitabine; Administered orally; Other Names: Xeloda®; Drug: Nab-paclitaxel; Administered intravenously; Other Names: Abraxane®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.	Up to approximately 29 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization until the date of death from any cause.	Until death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Until progression, up to approximately 60 months
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16	The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.	Baseline, Week 16
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores	Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.	Until progression or death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Up to approximately 60 months
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).	Until progression or death, up to approximately 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		First dose date up to 30 days post last dose, up to approximately 60 months
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities		First dose date up to 30 days post last dose, up to approximately 60 months

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Immunoconjugates; Paclitaxel; Capecitabine; Albumin-Bound Paclitaxel; Sacituzumab govitecan
• Other Study ID Numbers: GS-US-598-6168; 2022-502593-17-00 (Other Identifier: European Medicines Agency); jRCT2061230032 (Other Identifier: Japan Registry of Clinical Trials); DOH-27-082023-6901 (Other Identifier: South African National Clinical Trials Registry); MOH_2023-07-17_012821 (Other Identifier: Israel Clinical Research Site); CTR20233370 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No