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) (NCT05633654)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Alabama Oncology — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (356 Sites)
Showing the first 25 of 356 sites.
- Alabama Oncology — Birmingham, Alabama
- Clearview Cancer Institute — Huntsville, Alabama
- Palo Verde Hematology Oncology — Glendale, Arizona
- Mayo Clinic Hospital — Phoenix, Arizona
- Arizona Oncology Associates — Prescott Valley, Arizona
- Alta Bates Summit Medical Center — Berkeley, California
- Community Cancer Institute — Clovis, California
- PIH Health Whittier Hospital — Downey, California
- Compassionate Cancer Care Medical Group - Inc — Fountain Valley, California
- Los Angeles Cancer Network — Los Angeles, California
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Cedars-Sinai Cancer at Beverly Hills — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Emad Ibrahim, MD, INC — Redlands, California
- Sutter Institute for Medical Research — Sacramento, California
- City of Hope (Duarte) — San Francisco, California
- UCSF Medical Center — San Francisco, California
- Sansum Clinic — Santa Barbara, California
- Stockton Hematology Oncology Medical Group — Stockton, California
- University of Colorado Cancer Center — Aurora, Colorado
- Norwalk Hospital — Danbury, Connecticut
- Stamford Hospital — Stamford, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Morton Plant Hospital - Bay Care — Clearwater, Florida
📞 Contact the Study Coordinator
Phone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Triple Negative Breast Cancer
- Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer — Tucson, Arizona
- Comparison of the Breast Tumor Microenvironment — New York, New York
- Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer — Chicago, Illinois
- Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo — Mobile, Alabama
- Ribociclib and Bicalutamide in AR+ TNBC — Chicago, Illinois
- Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC — La Jolla, California
Explore by condition: All Triple Negative Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.