Sacituzumab Govitecan In TNBC
NCT04230109 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2025-10-14
Summary
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)
The names of the study drugs involved in this study is:
* Sacituzumab govitecan (SG)
* Pembrolizumab (combination therapy with SG)
Conditions
- Invasive Breast Cancer
- Triple Negative Breast Cancer
- ER-Negative Breast Cancer
- PR-Negative Breast Cancer
- HER2-negative Breast Cancer
Interventions
- DRUG
-
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
- DRUG
-
Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)
Sponsors & Collaborators
- collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Laura Spring, MD · Massachusetts General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-14
- Primary Completion
- 2028-10-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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