🏛️ Verified NIH Record • Updated 2025-12-23
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC (NCT04448886)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Ana C Garrido-Castro, MD
🩺 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 (Keytruda®; MK-3475)
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (15 items).
Location: Emory University/Winship Cancer Institute — Atlanta, Georgia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan. Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.
- Prior hypersensitivity to the excipients of pembrolizumab or sacituzumab govitecan therapy.
- Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) \*28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan. Note: Concurrent administration of strong UGT1A1 inhibitors or inducers is not allowed during the course of the study.
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
- Major surgery within 2 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator.
- Participant has a medical condition that requires chronic systemic steroid therapy (\> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.
- Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.
- Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as detected HCV RNA \[qualitative\]) infection. HIV-positive participants are ineligible due to the potential for pharmacokinetic interactions of combination antiretroviral therapy with study drugs and the increased risk of fatal infections. Note: No testing for HIV, Hepatitis B, or Hepatitis C is required unless mandated by local health authority.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Emory University/Winship Cancer Institute — Atlanta, Georgia
- University of Chicago Medical Center — Chicago, Illinois
- 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
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- University of Pennsylvania-Abramson Cancer Center — Philadelphia, Pennsylvania
💰 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.