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STATUS Recruiting

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)

LAST UPDATED

November 2, 2023

Clinicaltrials.gov ID

NCT05633654

OVERVIEW

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 (ASCENT-05)

PROTOCOL SUMMARY

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Triple Negative Breast Cancer

Gender

N/A

Date

December 2022 - June 2027

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine

Eligibility Information

Inclusion

Inclusion 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.
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Exclusion

Exclusion Criteria

  • 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.
  • 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 known 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (47)
Recruiting

Alabama Oncology

Birmingham, Alabama, United States, 35243

Recruiting

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

Recruiting

Palo Verde Hematology Oncology

Glendale, Arizona, United States, 85304

Recruiting

Compassionate Cancer Care Medical Group - Inc

Fountain Valley, California, United States, 92708

Recruiting

Los Angeles Cancer Network

Los Angeles, California, United States, 90017

Recruiting

Emad Ibrahim, MD, INC

Redlands, California, United States, 92373

Recruiting

UCSF Medical Center

San Francisco, California, United States, 94143

Recruiting

Stamford Hospital

Stamford, Connecticut, United States, 06902

Recruiting

Cancer Specialists of North Florida

Jacksonville, Florida, United States, 32256

Recruiting

Jupiter Medical Center

Jupiter, Florida, United States, 33458

Recruiting

Midland Florida Clinical Research Center, L

Orange City, Florida, United States, 32763

Recruiting

Orlando Health

Orlando, Florida, United States, 32806

Recruiting

Mount Sinai Health System

Athens, Georgia, United States, 30607

Recruiting

Piedmont Cancer Institute

Atlanta, Georgia, United States, 30318

Recruiting

Northside Hospital

Atlanta, Georgia, United States, 30342

Recruiting

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States, 30060

Recruiting

Edward Hospital

Naperville, Illinois, United States, 60540

Recruiting

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore

Skokie, Illinois, United States, 60076

Recruiting

IU Health Arnett Hospital

Lafayette, Indiana, United States, 47904

Recruiting

Mercy Medical Center

Cedar Rapids, Iowa, United States, 52403

Recruiting

Norton Healthcare, Inc.

Louisville, Kentucky, United States, 40207

Recruiting

Mercy Health

Paducah, Kentucky, United States, 42003

Recruiting

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809

Recruiting

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Recruiting

New England Cancer Specialists

Scarborough, Maine, United States, 04074

Recruiting

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States, 21237

Recruiting

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States, 20817

Recruiting

Baptist Clinical Research Institute

Saint Louis, Missouri, United States, 63131

Recruiting

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States, 08816

Recruiting

Summit Medical Group, P.A.

Florham Park, New Jersey, United States, 07932

Recruiting

Rutgers Health

New Brunswick, New Jersey, United States, 08901

Recruiting

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

Recruiting

Laura and Isaac Perlmutter Cancer Canter

New York, New York, United States, 10016

Recruiting

New York Cancer and Blood Specialists

Shirley, New York, United States, 11967

Recruiting

Stony Brook Medicine

Stony Brook, New York, United States, 11794

Recruiting

Clinical Research Alliance

Westbury, New York, United States, 11590

Recruiting

Samaritan Hospital

Corvallis, Oregon, United States, 97330

Recruiting

Providence Cancer Institute - Oncology Clinical Trials

Portland, Oregon, United States, 97213

Recruiting

Lancaster General Health

Lancaster, Pennsylvania, United States, 17601

Recruiting

Reading Hospital and Medical Center

West Reading, Pennsylvania, United States, 19611

Recruiting

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States, 57701

Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Recruiting

University of Tennessee

Knoxville, Tennessee, United States, 37920

Recruiting

MD Anderson Cancer Center

San Antonio, Texas, United States, 78229

Recruiting

University of Virginia

Charlottesville, Virginia, United States, 22908

Recruiting

Northwest Medical Specialties, PLLC

Puyallup, Washington, United States, 98373

Recruiting

Medical Oncology Associates

Spokane, Washington, United States, 99208