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NCT04109066 · ClinicalTrials.gov registry record · Phase 3
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 521
- Enrollment target
NCT04109066: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT04109066 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 521 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109066, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 521 participants
- Enrollment target
Study Summary
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
Primary Outcome
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL nivolumab
- DRUG paclitaxel (PTX)
- OTHER nivolumab placebo
- DRUG anthracycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 521 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2023-12-27 |
| Phase | Phase 3 |
What the finished NCT04109066 record still lists
NCT04109066 is an interventional study that assigns participants to a tested intervention. The registered 521 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT04109066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04109066 about?
NCT04109066 is a clinical study titled "Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer". A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-ne...
What is the current status of trial NCT04109066?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 2019-11-18. Estimated completion is 2023-12-27.
What interventions are being tested in trial NCT04109066?
The interventions under investigation include: cyclophosphamide (DRUG), nivolumab (BIOLOGICAL), paclitaxel (PTX) (DRUG), nivolumab placebo (OTHER), anthracycline (DRUG).
Who is sponsoring clinical trial NCT04109066?
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 NCT04109066's enrollment target sits among peer trials
521 717th of 2000 higher than 1,284 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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