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

Study details

Medical Condition

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

Gender

N/A

Date

May 2023 - April 2028

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 (288)

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

Chandler, Arizona, United States, 85224

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)

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OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (288)

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

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

Cleveland Clinic

Stefanie Spielman Comprehensive Breast Center

Penn State Cancer Institute

Magee-Womens of UPMC

Prisma Health - Upstate

Tennessee Oncology, PLLC

Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center

US Oncology Investigational Products Center (IPC)

US Oncology Investigational Products Center (IPC)

MultiCare Regional Cancer Center - Auburn

Hospital Britanico de Buenos Aires

Instituto de Investigaciones Clinicas de Mar del Plata

Instituto Alexander Fleming

Hospital Alemán

Centro Privado de RMI Rio Cuarto S.A.

Instituto de Oncología de Rosario

CER San Juan Centro Polivalente de Asistencia e Investigación Clínica

Royal Brisbane and Women's Hospital

St Vincent's Hospital Sydney

Liverpool Hospital

GenesisCare North Shore (Oncology)

Icon Cancer Centre Wesley

Flinders Medical Centre

Icon Cancer Centre Hobart

Austin Health

Sunshine Hospital (Western Health)

Breast Cancer Research Centre - WA

University Hospital Innsbruck

Universitätsklinik für Innere Medizin 3 der PMU

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

Klinikum Wels-Grieskirchen

GZA Ziekenhuizen - Campus Sint-Augustinus

AZ Klina

Cliniques Universitaires Saint-Luc

Universitaire Ziekenhuis Leuven

CHU UCL Namur-Site STE. Elisabeth

Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

Oncosite - Centro de Pesquisa Clinica e Oncologia

Catarina Pesquisa Clinica

Oncoclinicas do Brasil Servicos Medicos AS

Liga Norte-Rio-Grandense Contra o Câncer

CIONC-Centro Integrado de Oncologia de Curitiba

Hospital Erasto Gaertner

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Hospital de Clínicas de Porto Alegre - HCPA

HGB - Hospital Giovanni Battista/Mãe de Deus Center