Study on Cisplatin, Romidepsin, and Nivolumab for Locally Recurrent or Metastatic Triple Negative Breast Cancer

Sponsor: Priyanka Sharma

Sponsor score: 0

ClinicalTrials ID:NCT02393794

Provider View

This clinical trial is exploring a new combination of drugs—cisplatin, romidepsin, and nivolumab—to treat patients with triple negative breast cancer (TNBC) or breast cancer linked to BRCA mutations that has returned or spread.

Patient Parameters

Program Overview

The study aims to find out if a combination of three drugs—cisplatin, romidepsin, and nivolumab—can be safe and effective for treating patients with triple negative breast cancer (TNBC) or BRCA mutation-associated breast cancer that has come back or spread to other parts of the body. The study will be conducted in two phases: Phase I will determine the safest dose of romidepsin to use with cisplatin, and Phase II will test if the combination of all three drugs is safe and effective.

Description

Breast cancer is a common cancer and a leading cause of cancer-related deaths among women in the U.S. Despite advances in treatment, many women still die from breast cancer each year. When breast cancer progresses after standard chemotherapy, treatment options become limited, and recovery chances decrease.

This study is divided into two phases:

  • Phase I: The goal is to find the highest dose of romidepsin that can be safely combined with cisplatin.
  • Phase II: This phase will test if the combination of romidepsin (at the dose found in Phase I), cisplatin, and nivolumab is safe and effective for treating breast cancer.

Phase I must be completed before Phase II begins.

Eligibility Criteria

Inclusion Criteria

  • Must have one of the following:
    • Triple negative breast cancer (TNBC)
    • A confirmed BRCA1 or BRCA2 mutation, regardless of breast cancer type
  • Cancer must be stage III (not curable by surgery) or stage IV
  • Must have at least one tumor that can be measured by scans
  • No limit on previous treatments for metastatic breast cancer, but prior cisplatin treatment is not allowed unless it was given before cancer spread
  • Must have had at least one chemotherapy treatment for advanced cancer
  • Must be in relatively good health with an ECOG performance status of 2 or higher
  • Must meet specific blood test requirements
  • Radiation to bone metastases is allowed if done at least 14 days before starting the study
  • Women of childbearing potential and their partners must use contraception during the study and for 5 months after treatment

Exclusion Criteria

  • Cannot have received any cancer treatment within 14 days before starting the study
  • Must have recovered from any severe side effects of previous treatments
  • Cannot have any serious medical or psychiatric conditions that increase risk
  • Cannot be pregnant or breastfeeding
  • Cannot have been treated with certain immune or cancer drugs before
  • Cannot have active hepatitis B or C, or HIV/AIDS
  • Cannot have inflammatory breast cancer
  • Cannot have allergies to the study drugs
  • Cannot have another cancer within the last 3 years, except for certain skin or cervical cancers
  • Cannot have severe heart conditions or uncontrolled high blood pressure
  • Cannot have had major surgery within 14 days before starting the study
  • Cannot be taking certain medications that affect the heart or immune system

Locations

FACILITYZIPCITYSTATE
University of Kansas Cancer Center - Clinical Research Center66205FairwayKansas
University of Kansas Cancer Center - West66112Kansas CityKansas
University of Kansas Cancer Center - Overland Park66210Overland ParkKansas
University of Kansas Cancer Center - Westwood66205WestwoodKansas
University of Kansas Cancer Center - South64131Kansas CityMissouri
University of Kansas Cancer Center - North64154Kansas CityMissouri
University of Kansas Cancer Center - Lee's Summit64064Lee's SummitMissouri

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