๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-23

Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC (NCT04448886)

Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Ana C Garrido-Castro, MD

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytrudaยฎ; MK-3475)

Who can join: Review the eligibility criteria below.

Location: Emory University/Winship Cancer Institute โ€” Atlanta, Georgia

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • Emory University/Winship Cancer Institute โ€” Atlanta, Georgia
  • University of Chicago Medical Center โ€” Chicago, Illinois
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • DFCI @ Foxborough โ€” Foxborough, Massachusetts
  • DFCI @ Milford Regional Hospital โ€” Milford, Massachusetts
  • DF/BWCC in Clinical Affiliation with South Shore Hospital โ€” South Weymouth, Massachusetts
  • University of North Carolina at Chapel Hill โ€” Chapel Hill, North Carolina
  • University of Pennsylvania-Abramson Cancer Center โ€” Philadelphia, Pennsylvania

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—