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NCT03090165 · ClinicalTrials.gov registry record · Phase 1
Ribociclib and Bicalutamide in AR+ TNBC
A Phase 1 study of Triple Negative Breast Cancer, sponsored by Kari Wisinski.
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 6
- Study locations
NCT03090165: Active Phase 1 study of Triple Negative Breast Cancer, sponsored by Kari Wisinski.
NCT03090165 is a Phase 1 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by Kari Wisinski. The registered enrollment target is 37 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03090165, a Phase 1 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by Kari Wisinski.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.
Primary Outcome
Phase I: Maximum tolerated dose (MTD) for subjects receiving ribociclib and bicalutamide without experiencing dose-limiting toxicity(s) (DLT) per Common Terminology Criteria for Adverse Events (CTCAE) v4
Conditions Studied
Interventions
- DRUG Bicalutamide
- DRUG ribociclib
Study Locations (6)
Illinois
- University of Illinois Cancer Center - Chicago
Michigan
- Michigan State University - Lansing
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- University of Rochester Medical Center - Rochester
Pennsylvania
- Penn State Cancer Institute - Hershey
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What the registry record for NCT03090165 still lists
NCT03090165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bicalutamide is the first listed.
NCT03090165 lists 6 locations in 6 states (Illinois, Michigan, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03090165 about?
NCT03090165 is a clinical study titled "Ribociclib and Bicalutamide in AR+ TNBC". This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.
What is the current status of trial NCT03090165?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2018-05-07. Estimated completion is 2026-10.
What conditions does trial NCT03090165 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT03090165?
The interventions under investigation include: Bicalutamide (DRUG), ribociclib (DRUG).
Who is sponsoring clinical trial NCT03090165?
This trial is sponsored by Kari Wisinski, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03090165 being conducted?
This trial has 6 study locations across Illinois, Michigan, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative 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 NCT03090165's enrollment target sits among peer trials
37 88th of 118 higher than 31 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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