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NCT04468061 · ClinicalTrials.gov registry record · Phase 2
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 15
- Study locations
NCT04468061: Recruiting Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04468061 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 110 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468061, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 15
- Study locations
Study Summary
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)
Primary Outcome
Compare PFS of patients randomized to receive sacituzumab govitecan in combination with pembrolizumab (Arm A) versus those randomized to receive sacituzumab govitecan monotherapy (Arm B). Defined as the time from study randomization to disease progression, per RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Sacituzumab Govitecan
Study Locations (15)
Massachusetts
- Dana Farber Cancer Institute - Boston
- DFCI @ Foxborough - Foxborough
- DFCI @ Milford Regional Hospital - Milford
- DF/BWCC in Clinical Affiliation with South Shore Hospital - South Weymouth
Florida
- Miami Cancer Institute at Baptist Health (Kendall) - Miami
- Miami Cancer Institute at Baptist Health - Plantation
Ohio
- The Christ Hospital Cancer Center - Cincinnati
- Ohio State University Medical Center - Columbus
Connecticut
- Stamford Hospital - Stamford
Illinois
- University of Chicago Medical Center - Chicago
Maine
- Eastern Maine Medical Center - Brewer
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- University of Pennsylvania-Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2029-04-01 |
| Phase | Phase 2 |
What NCT04468061 shows while recruiting
NCT04468061 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04468061 lists 15 locations in 10 states (Massachusetts, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT04468061 about?
NCT04468061 is a clinical study titled "Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC". 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: *...
What is the current status of trial NCT04468061?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2020-07-20. Estimated completion is 2029-04-01.
What conditions does trial NCT04468061 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, PD-L1 Negative.
What interventions are being tested in trial NCT04468061?
The interventions under investigation include: Pembrolizumab (DRUG), Sacituzumab Govitecan (DRUG).
Who is sponsoring clinical trial NCT04468061?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04468061 being conducted?
This trial has 15 study locations across Connecticut, Florida, Illinois, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04468061's enrollment target sits among peer trials
110 536th of 1224 higher than 684 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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