CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 521 enrolled
Drug / intervention
nivolumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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Search/NCT04109066
NCT04109066Phase 3Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Sep 30, 2019·Updated Jan 8, 2025

In Brief

A Phase 3 clinical trial evaluating nivolumab, paclitaxel (PTX), and 5 other interventions for Breast Cancer. Completed, enrolled 521 participants across 240 sites in 32 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 30, 2019
Enrollment StartNov 18, 2019
Primary CompletionJan 16, 2023
Study CompletionDec 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.8 years ago

Interventions

nivolumabbiological

Specified Dose on Specified days

paclitaxel (PTX)drug

Specified dose on Specified days

nivolumab placeboother

Specified dose on Specified days

anthracyclinedrug

Specified dose on Specified days

cyclophosphamidedrug

Specified dose on Specified days

Endocrine Therapydrug

Variable endocrine therapy of investigators choice

Surgeryprocedure

Surgery for breast cancer