Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Description

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Conditions

Triple Negative Breast Cancer

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Study Overview

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Study Details

Study overview

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Oncology, Birmingham, Alabama, United States, 35243

Huntsville

Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Glendale

Palo Verde Hematology Oncology, Glendale, Arizona, United States, 85304

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Prescott Valley

Arizona Oncology Associates, Prescott Valley, Arizona, United States, 86314

Berkeley

Alta Bates Summit Medical Center, Berkeley, California, United States, 94704

Clovis

Community Cancer Institute, Clovis, California, United States, 93611

Downey

PIH Health Whittier Hospital, Downey, California, United States, 90241

Fountain Valley

Compassionate Cancer Care Medical Group - Inc, Fountain Valley, California, United States, 92708

Los Angeles

Los Angeles Cancer Network, Los Angeles, California, United States, 90017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
  • * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) \< 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
  • * Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
  • * Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • * Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.
  • * Adequate organ function.
  • * Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  • * Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior or concurrent treatment with any endocrine therapy agent.
  • * Evidence of recurrent disease following preoperative therapy and surgery.
  • * Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  • * Individuals with germline breast cancer gene (BRCA) mutations.
  • * Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \< 50%
  • * Active serious infections requiring anti-microbial therapy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2031-08