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NCT04075604 · ClinicalTrials.gov registry record · Phase 2
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT04075604: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT04075604 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075604, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
Primary Outcome
The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase. DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment. Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palb
Interventions
- DRUG Anastrozole
- DRUG Palbociclib
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 2 |
What the finished NCT04075604 record still lists
NCT04075604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Anastrozole is the first listed.
NCT04075604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04075604 about?
NCT04075604 is a clinical study titled "A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer". A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
What is the current status of trial NCT04075604?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2019-10-18. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT04075604?
The interventions under investigation include: Anastrozole (DRUG), Palbociclib (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04075604?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04075604's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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