Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

NCT03901339 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: IMMU-132-092018-004201-33
• Study Type: interventional
• Target: 543
• Locations: 9 countries
• Sites: 113

Brief Summary

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment

  PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.

  Up to 42.8 months

Secondary Outcomes (12)

• Overall Survival (OS)

  Up to 42.8 months

• Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment

  Up to 42.8 months

• Duration of Response (DOR) by BICR and LIR Assessment

  Up to 42.8 months

• Clinical Benefit Rate (CBR) by BICR and LIR Assessment

  Up to 42.8 months

• PFS by LIR Assessment

  Up to 42.8 months

Study Arms (2)

Sacituzumab Govitecan-hziy

EXPERIMENTAL

Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.

Drug: Sacituzumab Govitecan-hziy

Treatment of Physician's Choice (TPC)

ACTIVE COMPARATOR

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment: Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic) * Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle * Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle * Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution * Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution

Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

Interventions

Sacituzumab Govitecan-hziy DRUG

Administered intravenously

Also known as: IMMU-132, GS-0132

Sacituzumab Govitecan-hziy

Eribulin DRUG

Administered intravenously per NCCN guidelines

Treatment of Physician's Choice (TPC)

Capecitabine DRUG

Administered orally per NCCN guidelines

Treatment of Physician's Choice (TPC)

Gemcitabine DRUG

Administered intravenously per NCCN guidelines

Treatment of Physician's Choice (TPC)

Vinorelbine DRUG

Administered intravenously per NCCN guidelines

Treatment of Physician's Choice (TPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.
• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:
• At least 1 taxane in any setting.
• At least 1 prior anticancer hormonal treatment in any setting.
• At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
• Eligible for one of the chemotherapy options listed in the TPC arm.
• Documented disease progression after the most recent therapy.
• Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm\^3, platelets ≥ 100,000 per mm\^3).
• Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
• Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).

You may not qualify if:

• Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
• History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
• Active serious infection requiring antibiotics.
• Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
• Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (113)

HonorHealth Research Institute

Avondale, Arizona, 85392, United States

Location

Arizona Oncology Associates, PC

Tucson, Arizona, 85704, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, 90095, United States

Location

University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University Cancer Center

New Haven, Connecticut, 06520, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northside Hospital, Inc.

Atlanta, Georgia, 30342, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Mercy Medical Center, Medical Oncology & Hematology

Baltimore, Maryland, 21202, United States

Location

Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Allina Health, Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Laura and Isaac Perlmutter Cancer Center/NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

The West Clinic, PC dba West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

Texas Oncology-Denton South

Denton, Texas, 76210, United States

Location

Houston Methodist Hospital/Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology-Longview Cancer Center

Longview, Texas, 75601, United States

Location

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Arlington, Virginia, 22205, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care

Salem, Virginia, 24153, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Chirec Cancer Institute

Brussels, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame

Montreal, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

Sherbrooke, Canada

Location

Hopital de Mercy

Ars-Laquenexy, 57245, France

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Hôpital Jean-Minjoz

Besançon, 25030, France

Location

Centre Georges-Francois Leclerc

Dijon, 21000, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, 75005, France

Location

Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Institut Claudius Regaud

Toulouse, 31300, France

Location

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Gynakologisches Zentrum Bonn

Bonn, 53111, Germany

Location

Marienhospital Bottrop

Bottrop, 46236, Germany

Location

Städtisches Klinikum Dessau

Dessau, 06847, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, 60389, Germany

Location

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, 20249, Germany

Location

Gynakologisch-Onkologische Praxis Hannover

Hanover, 30177, Germany

Location

DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode

Hanover, Germany

Location

Nationales Centrum für Tumorerkrankungen - Heidelberg

Heidelberg, 69120, Germany

Location

Praxisklinik für Hämatologie und Onkologie Koblenz

Koblenz, 56068, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Klinikum Mutterhaus der Borromäerinnen

Trier, Germany

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale di Desio

Desio, 20832, Italy

Location

Ospedale Vito Fazzi di Lecce

Lecce, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy

Location

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

Piacenza, 29121, Italy

Location

IFO Istituto Nazionale dei Tumori Regina Elena

Rome, 00144, Italy

Location

Antoni van Leeuwenhoekziekenhuis

Amsterdam, 1066, Netherlands

Location

Medisch Centrum Haaglanden Antoniushove

Leidschendam, Netherlands

Location

Maastricht UMC+

Maastricht, 6229, Netherlands

Location

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

Location

Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital Provincial de Castellón

Castillón, 12002, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Instituto Oncologico Bureau (IOB)

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Royal Cornwall Hospital NHS Trust

Cornwell, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (8)

• Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.

  PMID: 37633306 BACKGROUND

• Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.

  PMID: 36027558 BACKGROUND

• Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.

  PMID: 32223649 BACKGROUND

• Rugo HS, Schmid P, Tolaney SM, Dalenc F, Marme F, Shi L, Verret W, Shah A, Gharaibeh M, Bardia A, Cortes J. Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial. Oncologist. 2024 Sep 6;29(9):768-779. doi: 10.1093/oncolo/oyae088.

  PMID: 38748596 BACKGROUND

• Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Spears PA, Tolaney SM. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024 Apr;20(11):635-651. doi: 10.2217/fon-2023-0845. Epub 2024 Jan 25.

  PMID: 38270051 BACKGROUND

• Rugo HS, Bardia A, Tolaney S. Sacituzumab govitecan for metastatic breast cancer: the TROPiCS-02 trial - Authors' reply. Lancet. 2024 Jul 27;404(10450):339-340. doi: 10.1016/S0140-6736(24)01049-3. No abstract available.

  PMID: 39067902 BACKGROUND

• McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.

  PMID: 33093337 DERIVED

• Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.

  PMID: 32946924 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan; eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 3, 2019
• Study Start: May 8, 2019
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

FR (10); US (55); NL (3); GB (6); ES (11); BE (4); CA (3); DE (14); IT (7)