Study on Carboplatin with or without Nivolumab for Treating Metastatic Triple Negative Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03414684

This clinical trial is exploring whether the chemotherapy drug Carboplatin, alone or combined with the immunotherapy drug Nivolumab, can effectively treat triple-negative breast cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing the effectiveness of Carboplatin, a chemotherapy drug, with or without Nivolumab, an immunotherapy drug, in treating triple-negative breast cancer that has metastasized, meaning it has spread to other areas of the body. While Carboplatin is already approved for treating this type of cancer, Nivolumab is not yet approved for this specific use but has shown promise in other studies. Nivolumab works by helping the immune system recognize and attack cancer cells. This study aims to see if adding Nivolumab to Carboplatin can improve treatment outcomes for patients with this aggressive form of breast cancer.

Description

This Phase II clinical trial is investigating whether Carboplatin, a chemotherapy drug, alone or in combination with Nivolumab, an immunotherapy drug, can effectively treat metastatic triple-negative breast cancer. Nivolumab is a type of protein that helps the immune system target and destroy cancer cells by blocking a molecule called PD-1, which can turn off the immune response. This study will help determine if this combination can shrink or stabilize tumors in patients with this type of cancer. Participants will be monitored for safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed invasive breast cancer that cannot be surgically removed and has spread to other parts of the body.
  • Cancer must be triple-negative, meaning low levels of estrogen and progesterone receptors and HER2-negative.
  • Must have PD-L1 status available from a certified lab test.
  • Must have measurable or evaluable disease based on specific criteria.
  • Must agree to provide a tumor sample for research purposes, if safely accessible.
  • Must not have received prior chemotherapy for metastatic breast cancer.
  • Must be 18 years or older.
  • Must have good overall health with normal organ and marrow function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Must be able to understand and agree to the study requirements.

Exclusion Criteria

  • Cannot receive other anti-cancer treatments during the study.
  • Cannot have allergies to platinum chemotherapy or Nivolumab.
  • Cannot have untreated or symptomatic brain metastases.
  • Cannot have had major surgery within two weeks before joining the study.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot require chronic steroid or immunosuppressive therapy.
  • Cannot have a history of autoimmune diseases requiring treatment.
  • Cannot have active lung diseases like pneumonitis.
  • Cannot have had another cancer within the last three years, except for certain low-risk cancers.
  • Cannot be HIV positive or have active hepatitis B or C.
  • Cannot have received a live vaccine within 28 days before joining the study.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
The Stamford Hospital06904StamfordConnecticut
Eastern Maine Medical Center04401BangorMaine
Beth Israel Deaconess Medical Center02115BostonMassachusetts
Dana-Farber Cancer Institute02115BostonMassachusetts
St. Elizabeth's Medical Center02135BostonMassachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center01757MilfordMassachusetts
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital02190South WeymouthMassachusetts
Dana-Farber/New Hampshire Oncology-Hematology03053LondonderryNew Hampshire
Ohio State University43210ColumbusOhio
University of Vermont Medical Center05401BurlingtonVermont

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