# 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

> **NCT04109066** · PHASE3 · COMPLETED · sponsor: **Bristol-Myers Squibb** · enrollment: 521 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **BIOLOGICAL:** nivolumab
- **DRUG:** paclitaxel (PTX)
- **OTHER:** nivolumab placebo
- **DRUG:** anthracycline
- **DRUG:** cyclophosphamide
- **DRUG:** Endocrine Therapy
- **PROCEDURE:** Surgery

## Key facts

- **NCT ID:** NCT04109066
- **Lead sponsor:** Bristol-Myers Squibb
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-11-18
- **Primary completion:** 2023-01-16
- **Final completion:** 2023-12-27
- **Target enrollment:** 521 (ACTUAL)
- **Last updated:** 2025-01-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04109066

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04109066, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04109066. Licensed CC0.

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