Study on Nivolumab and Ipilimumab for Treating Metastatic Hypermutated HER2-negative Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03789110

Provider View

This clinical trial is exploring a combination of two drugs, nivolumab and ipilimumab, to see if they can effectively treat breast cancer that has spread and is HER2-negative. These drugs aim to boost the immune system to fight cancer.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, nivolumab and ipilimumab, to see if they can help treat breast cancer that has spread to other parts of the body and is HER2-negative. Nivolumab and ipilimumab are designed to help the immune system attack cancer cells. Although these drugs are approved for other cancers, they are not yet approved for this specific type of breast cancer. The study will also look at whether certain markers in the blood or tumor tissue can predict how well the treatment works.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment. The treatment involves two drugs: nivolumab, which helps the immune system attack cancer cells, and ipilimumab, which prevents the immune system from stopping its attack on cancer. These drugs are already used for other cancers but are being tested here for breast cancer that has spread and is HER2-negative. The study aims to find out if this combination can help treat this type of cancer and if certain markers in the blood or tumor tissue can predict treatment success.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed invasive breast cancer that has spread to other parts of the body.
  • The cancer must be HER2-negative and may be either ER/PR positive or negative.
  • Tumors must have a high number of mutations, as determined by specific tests.
  • Have measurable cancer that can be tracked during the study.
  • Agree to provide a tumor sample for research purposes.
  • Have received up to three previous chemotherapy treatments for metastatic breast cancer and have stopped treatment at least 14 days before starting the study.
  • If the cancer is hormone receptor positive, it must have progressed after at least one hormone therapy.
  • Be recovered from any side effects of previous treatments, except for hair loss or mild nerve damage.
  • Be 18 years or older.
  • Have a good performance status, meaning you are fully active or have some restrictions but can still do light work.
  • Have normal organ and bone marrow function based on specific blood tests.
  • 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.
  • Be able to understand and agree to the study requirements.

Exclusion Criteria

  • Have had major surgery within two weeks before starting the study.
  • Are currently receiving other cancer treatments or have received investigational drugs within 14 days before the study.
  • Have previously been treated with similar immune therapies.
  • Have untreated or symptomatic brain metastases.
  • Have uncontrolled or significant health issues.
  • Have an active infection requiring IV antibiotics.
  • Require chronic steroid or immunosuppressive therapy.
  • Have current lung inflammation or need oxygen therapy.
  • Are positive for HIV, hepatitis B, or hepatitis C.
  • Have another active cancer needing treatment.
  • Are allergic to the study drugs.
  • Have received a live vaccine within 28 days before starting the study.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts
University of Pittsburgh Medical Center15213PittsburghPennsylvania
University of Texas Southwestern Medical Center75390DallasTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.