Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03414684
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Carboplatin interferes with the development of the genetic material in a cell, which will cause the cancer cells to die.
  • Nivolumab — DRUG
    Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cells

Study Details

This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body. The interventions involved in this study are: * Carboplatin * Nivolumab

Key Dates

Start date
Jan 30, 2018
Status verified
Sep 2025
Primary completion
Sep 28, 2021
Completion
Jul 30, 2026

Study Design

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

Arms

  • Experimental: Carboplatin + Nivolumab
    * Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI
  • Active Comparator: Carboplatin
    * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI

Primary Outcome Measure

Progression-free Survival [ Time Frame: Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
The Stamford HospitalStamfordConnecticut06904-
Eastern Maine Medical CenterBangorMaine04401-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
St. Elizabeth's Medical CenterBostonMassachusetts02135-
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical CenterMilfordMassachusetts01757-
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore HospitalSouth WeymouthMassachusetts02190-
Dana-Farber/New Hampshire Oncology-HematologyLondonderryNew Hampshire03053-
Ohio State UniversityColumbusOhio43210-
University of Vermont Medical CenterBurlingtonVermont05401-

Find similar trials in Stamford, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The Stamford Hospital· Stamford, CTEastern Maine Medical Center· Bangor, MEBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MASt. Elizabeth's Medical Center· Boston, MADana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center· Milford, MA

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