A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

Part of paid clinical trials in Whittier, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04075604
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified Dose on Specified Days
  • Anastrozole — DRUG
    Specified Dose on Specified Days
  • Palbociclib — DRUG
    Specified Dose on Specified Days

Study Details

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

Key Dates

Start date
Oct 18, 2019
Status verified
Jul 2022
Primary completion
Jul 27, 2021
Completion
Jul 27, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ)
  • Experimental: Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ
  • Active Comparator: Arm C: Palbociclib+ANZ

Primary Outcome Measure

The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase [ Time Frame: From first dose to 4 weeks after first dose ]

Locations (9)

FacilityCityStateZIPSite coordinators
Local Institution - 0031WhittierCalifornia90603-
University Cancer Blood CtrAthensGeorgia30607-
Northside Hospital,Inc.- Central Research DepartmentAtlantaGeorgia30342-
Northwestern UniversityChicagoIllinois60611-
Local Institution - 0041Florham ParkNew Jersey07932-
The Cancer Center At Hackensack University Medical CenterHackensackNew Jersey07601-
MetroHealth Medical CenterClevelandOhio44109-
Hematology-Oncology Associates Of Fredricksburg, IncFredericksburgVirginia22408-
Peninsula Cancer InstituteNewport NewsVirginia23601-

Find similar trials in Whittier, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Local Institution - 0031· Whittier, CAUniversity Cancer Blood Ctr· Athens, GANorthside Hospital,Inc.- Central Research Department· Atlanta, GANorthwestern University· Chicago, ILLocal Institution - 0041· Florham Park, NJThe Cancer Center At Hackensack University Medical Center· Hackensack, NJ

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