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Search / Trial NCT05633654

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/GBG 119/NSABP B-63)

Launched by GILEAD SCIENCES · Nov 21, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Aft 65 Gbg 119 Nsabp B 63 Optim Ice Rd

ClinConnect Summary

The ASCENT-05 clinical trial is studying a new treatment approach for patients with triple negative breast cancer (TNBC) who still have cancer remaining after surgery and previous therapy. This trial is comparing an experimental treatment that combines sacituzumab govitecan-hziy (SG) with pembrolizumab to the standard treatment options, which may include pembrolizumab alone or pembrolizumab with another medication called capecitabine. The goal is to find out if this new combination is more effective and safe for patients.

To participate in this trial, patients must be over 18 years old and have residual invasive TNBC in the breast or lymph nodes after receiving surgery and pre-surgical treatment. They should have had their cancer surgically removed, recovered from that surgery, and undergone appropriate radiotherapy. Importantly, patients with more advanced stages of cancer or certain health conditions may not be eligible. Participants can expect to receive close monitoring and support throughout the study, contributing valuable information to help improve future treatments for TNBC.

Gender

ALL

Eligibility criteria

  • Key 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.
  • Key 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, prior endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.

Locations

Worcester, Massachusetts, United States

Sacramento, California, United States

Lexington, Kentucky, United States

Rochester, Minnesota, United States

Charleston, South Carolina, United States

Charlottesville, Virginia, United States

Bronx, New York, United States

Madison, Wisconsin, United States

Buffalo, New York, United States

Boston, Massachusetts, United States

Sioux Falls, South Dakota, United States

Baton Rouge, Louisiana, United States

Royal Oak, Michigan, United States

Oklahoma City, Oklahoma, United States

Salt Lake City, Utah, United States

Chicago, Illinois, United States

Miami Beach, Florida, United States

Urbana, Illinois, United States

Cedar Rapids, Iowa, United States

Lubbock, Texas, United States

Malaga, , Spain

Boston, Massachusetts, United States

Durham, North Carolina, United States

Detroit, Michigan, United States

Barcelona, , Spain

Albuquerque, New Mexico, United States

Clovis, California, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Wynnewood, Pennsylvania, United States

Washington, District Of Columbia, United States

Syracuse, New York, United States

Gainesville, Florida, United States

Stockton, California, United States

Houston, Texas, United States

Chicago, Illinois, United States

Portland, Oregon, United States

Cincinnati, Ohio, United States

Newport Beach, California, United States

Aurora, Colorado, United States

Stony Brook, New York, United States

Sayre, Pennsylvania, United States

Spartanburg, South Carolina, United States

Farmington, New Mexico, United States

Philadelphia, Pennsylvania, United States

Atlanta, Georgia, United States

Phoenix, Arizona, United States

Huntsville, Alabama, United States

Jupiter, Florida, United States

New Orleans, Louisiana, United States

Flemington, New Jersey, United States

Glendale, Arizona, United States

San Francisco, California, United States

Los Angeles, California, United States

Richmond, Virginia, United States

Jacksonville, Florida, United States

Clayton, Victoria, Australia

Indianapolis, Indiana, United States

Appleton, Wisconsin, United States

Baltimore, Maryland, United States

Minneapolis, Minnesota, United States

Barcelona, , Spain

Valencia, , Spain

Granada, , Spain

Cincinnati, Ohio, United States

Raleigh, North Carolina, United States

Sevilla, , Spain

Lyon, , France

Marietta, Georgia, United States

Mannheim, , Germany

Knoxville, Tennessee, United States

Las Vegas, Nevada, United States

Evanston, Illinois, United States

Baltimore, Maryland, United States

Murcia, , Spain

Kingsport, Tennessee, United States

Orlando, Florida, United States

Santa Barbara, California, United States

Naperville, Illinois, United States

Chapel Hill, North Carolina, United States

Esslingen, , Germany

Berkeley, California, United States

Elche, , Spain

West Reading, Pennsylvania, United States

Indianapolis, Indiana, United States

Lacey, Washington, United States

Scarborough, Maine, United States

Westbury, New York, United States

Stamford, Connecticut, United States

Saint Louis, Missouri, United States

Columbus, Ohio, United States

Grand Rapids, Michigan, United States

Rennes Cedex, , France

Le Mans, , France

Atlanta, Georgia, United States

Eugene, Oregon, United States

Dortmund, , Germany

Summit, New Jersey, United States

Jacksonville, Florida, United States

Jaen, , Spain

Pensacola, Florida, United States

Chicago, Illinois, United States

Spokane, Washington, United States

Lancaster, Pennsylvania, United States

York, Pennsylvania, United States

Birmingham, Alabama, United States

Roanoke, Virginia, United States

Towson, Maryland, United States

Austin, Texas, United States

Pembroke Pines, Florida, United States

Gateshead, New South Wales, Australia

Morgantown, West Virginia, United States

Florham Park, New Jersey, United States

Valdosta, Georgia, United States

Medford, Oregon, United States

Toledo, Ohio, United States

Knoxville, Tennessee, United States

Castellón, , Spain

Lake Success, New York, United States

Pinehurst, North Carolina, United States

East Brunswick, New Jersey, United States

Redlands, California, United States

Baltimore, Maryland, United States

Coeur D'alene, Idaho, United States

Badalona, , Spain

Los Angeles, California, United States

Tampa, Florida, United States

El Paso, Texas, United States

Plantation, Florida, United States

Bethesda, Maryland, United States

Port Jefferson Station, New York, United States

Winston Salem, North Carolina, United States

Valladolid, , Spain

Braunschweig, , Germany

Southfield, Michigan, United States

East Syracuse, New York, United States

Baltimore, Maryland, United States

Granada, , Spain

Galdakao, , Spain

New Brunswick, New Jersey, United States

Bremen, , Germany

San Antonio, Texas, United States

Rapid City, South Dakota, United States

Puyallup, Washington, United States

Prescott Valley, Arizona, United States

Louisville, Kentucky, United States

Paducah, Kentucky, United States

Fountain Valley, California, United States

Munster, Indiana, United States

Orange, Florida, United States

Lafayette, Indiana, United States

Dublin, , Ireland

Orange City, Florida, United States

Skokie, Illinois, United States

San Antonio, Texas, United States

Athens, Georgia, United States

New York, New York, United States

Saint Louis, Missouri, United States

Shirley, New York, United States

Corvallis, Oregon, United States

Portland, Oregon, United States

Downey, California, United States

River Forest, Illinois, United States

Des Moines, Iowa, United States

Frederick, Maryland, United States

Saint Louis Park, Minnesota, United States

Middletown, Ohio, United States

Danbury, Connecticut, United States

Athens, Georgia, United States

Springfield, Illinois, United States

Minneapolis, Minnesota, United States

Rochester, New York, United States

Clearwater, Florida, United States

Palm Bay, Florida, United States

Omaha, Nebraska, United States

Renton, Washington, United States

Boise, Idaho, United States

Amsterdam, New York, United States

White Plains, New York, United States

Providence, Rhode Island, United States

Hastings, Nebraska, United States

Omaha, Nebraska, United States

Columbus, Ohio, United States

Stuart, Florida, United States

Springfield, Massachusetts, United States

Grosse Pointe Woods, Michigan, United States

Maplewood, Minnesota, United States

Reno, Nevada, United States

Rocky Mount, North Carolina, United States

Bend, Oregon, United States

Bethlehem, Pennsylvania, United States

Abilene, Texas, United States

Augsburg, , Germany

Weston, Florida, United States

Fairfield, Iowa, United States

Indianapolis, Iowa, United States

Reno, Nevada, United States

Greensboro, North Carolina, United States

Columbus, Ohio, United States

Wytheville, Virginia, United States

Franklin, Wisconsin, United States

Green Bay, Wisconsin, United States

Ypsilanti, Michigan, United States

Greenville, North Carolina, United States

Los Angeles, California, United States

Georgsmarienhütte, , Germany

Koblenz, , Germany

Köln, , Germany

Barakaldo, , Spain

Kassel, , Germany

Puyallup, Washington, United States

Worms, , Germany

A Coruña, , Spain

Manresa, , Spain

Santander, , Spain

Zaragoza, , Spain

Campbelltown, New South Wales, Australia

Chambray Les Tours, , France

Plerin, , France

Toulouse, , France

Berlin, , Germany

Bielefeld, , Germany

Bottrop, , Germany

Hamburg, , Germany

Karlsruhe, , Germany

Ravensburg, , Germany

Stade, , Germany

Stuttgart, , Germany

Tuebingen, , Germany

Wuppertal, , Germany

Caceres, , Spain

Pamplona, , Spain

Seville, , Spain

Patients applied

0 patients applied

Trial Officials

Gilead Study Director

Study Director

Gilead Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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