Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 521 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04109066
The ClinicalTrials.gov registry entry for NCT04109066 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 521 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT04109066 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.