Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC (NCT04468061)
Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
🩺 Plain-English Summary (8th-Grade Level)
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Who can join: Review the eligibility criteria below.
Location: Stamford Hospital — Stamford, Connecticut
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 (15 Sites)
- Stamford Hospital — Stamford, Connecticut
- Miami Cancer Institute at Baptist Health (Kendall) — Miami, Florida
- Miami Cancer Institute at Baptist Health — Plantation, Florida
- University of Chicago Medical Center — Chicago, Illinois
- Eastern Maine Medical Center — Brewer, Maine
- Dana Farber Cancer Institute — Boston, Massachusetts
- DFCI @ Foxborough — Foxborough, Massachusetts
- DFCI @ Milford Regional Hospital — Milford, Massachusetts
- DF/BWCC in Clinical Affiliation with South Shore Hospital — South Weymouth, Massachusetts
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- The Christ Hospital Cancer Center — Cincinnati, Ohio
- Ohio State University Medical Center — Columbus, Ohio
- University of Pennsylvania-Abramson Cancer Center — Philadelphia, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Sarah Cannon Research Institute — Chattanooga, Tennessee
📞 Contact the Study Coordinator
Phone: (617) 632-6409
Email: Ana_Garrido-Castro@dfci.harvard.edu
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.
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💡 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.