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
Public ClinicalTrials.gov record NCT04109066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Study identification
- NCT ID
- NCT04109066
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bristol-Myers Squibb
- Industry
- Enrollment
- 521 participants
Conditions and interventions
Conditions
Interventions
- Endocrine Therapy Drug
- Surgery Procedure
- anthracycline Drug
- cyclophosphamide Drug
- nivolumab Biological
- nivolumab placebo Other
- paclitaxel (PTX) Drug
Drug · Procedure · Biological + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 17, 2019
- Primary completion
- Jan 15, 2023
- Completion
- Dec 26, 2023
- Last update posted
- Jan 7, 2025
2019 – 2023
United States locations
- U.S. sites
- 30
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0136 | Mobile | Alabama | 36604 | — |
| Local Institution - 0052 | Greenbrae | California | 94904 | — |
| Local Institution - 0051 | Whittier | California | 90603 | — |
| Local Institution - 0182 | Stamford | Connecticut | 06904 | — |
| Local Institution - 0150 | Jacksonville | Florida | 32256 | — |
| Local Institution - 0097 | Miami | Florida | 33136 | — |
| Local Institution - 0149 | Pensacola | Florida | 32504 | — |
| Local Institution - 0120 | Tallahassee | Florida | 32308 | — |
| Local Institution - 0054 | Athens | Georgia | 30607 | — |
| Local Institution - 0107 | Atlanta | Georgia | 30342 | — |
| Local Institution - 0056 | Columbus | Georgia | 31904 | — |
| Local Institution - 0221 | Chicago | Illinois | 60611 | — |
| Local Institution - 0227 | Fort Wayne | Indiana | 46804 | — |
| Local Institution - 0222 | Topsham | Maine | 04086 | — |
| Local Institution - 0146 | Bethesda | Maryland | 20817 | — |
| HCA Midwest Division | Kansas City | Missouri | 64132 | — |
| Local Institution - 0109 | Florham Park | New Jersey | 07932 | — |
| Local Institution - 0050 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 0180 | New Brunswick | New Jersey | 08903 | — |
| Local Institution - 0181 | Albuquerque | New Mexico | 87131 | — |
| Local Institution - 0041 | The Bronx | New York | 10461 | — |
| Local Institution - 0283 | Charlotte | North Carolina | 28204 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| Local Institution - 0053 | Cleveland | Ohio | 44109 | — |
| Local Institution - 0218 | Nashville | Tennessee | 37203 | — |
| Local Institution - 0121 | Fort Worth | Texas | 76104 | — |
| Local Institution - 0224 | Fairfax | Virginia | 22031 | — |
| Local Institution - 0122 | Fredericksburg | Virginia | 22408 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | — |
| Local Institution - 0274 | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 210 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04109066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2025 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04109066 live on ClinicalTrials.gov.