Trials / Completed
CompletedNCT04109066
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, 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 521 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | nivolumab | Specified Dose on Specified days |
| DRUG | paclitaxel (PTX) | Specified dose on Specified days |
| OTHER | nivolumab placebo | Specified dose on Specified days |
| DRUG | anthracycline | Specified dose on Specified days |
| DRUG | cyclophosphamide | Specified dose on Specified days |
| DRUG | Endocrine Therapy | Variable endocrine therapy of investigators choice |
| PROCEDURE | Surgery | Surgery for breast cancer |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2023-01-16
- Completion
- 2023-12-27
- First posted
- 2019-09-30
- Last updated
- 2025-01-08
- Results posted
- 2024-03-12
Locations
240 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04109066. Inclusion in this directory is not an endorsement.