Study on Atezolizumab and Stereotactic Radiation for Treating Triple-negative Breast Cancer with Brain Metastasis

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03483012

Provider View

This clinical trial is exploring a new treatment combining the drug atezolizumab with a precise radiation technique called stereotactic radiosurgery (SRS) to treat triple-negative breast cancer that has spread to the brain.

Patient Parameters

Program Overview

The purpose of this study is to test if combining atezolizumab, a drug that helps the immune system fight cancer, with stereotactic radiosurgery (SRS), a precise form of radiation therapy, can effectively treat triple-negative breast cancer that has spread to the brain. Atezolizumab works by blocking a pathway that tumors use to hide from the immune system, while SRS targets and damages cancer cells in the brain with focused radiation. Researchers hope that using these treatments together will improve the body's ability to fight cancer compared to using each treatment alone.

Description

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment approach. Atezolizumab is a drug that helps the immune system recognize and attack cancer cells by blocking a pathway called PD-L1. This pathway can be used by tumors to avoid being detected by the immune system. Stereotactic radiosurgery (SRS) is a type of radiation therapy that uses precise beams to target brain tumors without making any incisions. It aims to shrink tumors by damaging their DNA, preventing them from growing and spreading.

The study will investigate whether combining atezolizumab with SRS can enhance the immune system's response to cancer and improve treatment outcomes. Participants will receive both treatments and researchers will monitor how long the cancer stays under control and how well the combination works. The safety of using these treatments together will also be assessed.

Participants will need to meet certain criteria to join the study, such as having triple-negative breast cancer that has spread to the brain and being in good overall health. The study will involve regular check-ups and tests to track the participants' health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed Stage IV invasive breast cancer, with either the primary or metastatic tumor being triple-negative.
  • Have brain metastases that require stereotactic radiosurgery (SRS), as determined by a radiation oncologist.
  • Have no more than 5 new or growing brain lesions that need SRS treatment.
  • Have measurable cancer outside the brain.
  • Be willing to undergo a research biopsy if it is safe to do so.
  • Have stopped any previous cancer treatments at least 14 days before starting the study treatment.
  • Be 18 years or older.
  • Have a performance status that allows for daily activities with some restrictions.
  • Have stable organ and marrow function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last treatment.

Exclusion Criteria

  • Have urgent brain complications that need surgery.
  • Have leptomeningeal or brainstem metastases.
  • Be on high-dose steroids or unable to undergo MRI with contrast.
  • Be receiving other investigational treatments.
  • Have had previous treatment with similar immune therapies.
  • Have uncontrolled health conditions like severe heart disease or diabetes.
  • Be on chronic steroid therapy or have active lung inflammation.
  • Be positive for HIV, hepatitis B, or hepatitis C.
  • Have had another cancer unless disease-free for at least 3 years.
  • Have received a live vaccine recently.
  • Be pregnant or breastfeeding.

Get This Program In Your Inbox

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