Trials / Completed
CompletedNCT04075604
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified Dose on Specified Days |
| DRUG | Anastrozole | Specified Dose on Specified Days |
| DRUG | Palbociclib | Specified Dose on Specified Days |
Timeline
- Start date
- 2019-10-18
- Primary completion
- 2021-07-27
- Completion
- 2021-07-27
- First posted
- 2019-09-03
- Last updated
- 2022-08-10
- Results posted
- 2022-08-10
Locations
36 sites across 8 countries: United States, Australia, Belgium, Canada, France, Germany, Puerto Rico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04075604. Inclusion in this directory is not an endorsement.