Study on Pembrolizumab and Targeted Brain Radiation for Breast Cancer Patients with Brain Metastases

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03449238

Provider View

This clinical trial is testing a combination of the drug pembrolizumab and targeted radiation therapy to treat brain metastases in patients with metastatic breast cancer. The study aims to determine if this approach is safe and effective in controlling the cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate whether pembrolizumab, given every three weeks, along with targeted radiation therapy to specific brain tumors, can help manage metastatic breast cancer that has spread to the brain. Patients will receive pembrolizumab infusions starting four days after the radiation treatment and continue every three weeks until the cancer progresses or side effects become too severe.

Description

This study involves patients with metastatic breast cancer who have at least two brain tumors. Participants will receive a type of radiation therapy called stereotactic radiosurgery (SRS) to one of the brain tumors. Pembrolizumab, an immunotherapy drug, will be given as an infusion starting four days after the SRS treatment and will be repeated every three weeks. The treatment will continue until the cancer shows signs of progression in the brain or if the patient experiences serious side effects. Patients will be monitored throughout the study and followed until death to assess the treatment's effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

  • Must be older than 18 years.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have good neurological function.
  • Have metastatic breast cancer with at least two untreated brain tumors that are 5mm or larger, as seen on an MRI scan.
  • Have between two and ten measurable brain tumors, each at least 5mm in size, confirmed by a recent MRI.
  • Tumors to be treated should be less than 4cm in size.
  • Have measurable disease based on standard criteria, even if previously treated with radiation.
  • Be able to understand and sign a consent form.
  • Previous SRS is allowed, but the tumors targeted in this study must not have been treated with SRS before.
  • If previously had partial tumor removal, remaining tumor must be less than 4cm.
  • Can continue hormonal or anti-Her2 therapy if brain tumors are progressing during these treatments.
  • Must have a two-week break from last systemic treatment before starting the study.
  • Must agree to use contraception for 120 days.
  • Have adequate bone marrow and liver function.

Exclusion Criteria

  • Have active connective tissue disorders like lupus or scleroderma needing treatment.
  • Have had all known brain tumors completely removed.
  • Cannot provide proof of breast cancer diagnosis.
  • Have a tumor too close to the optic nerve that would be affected by radiation.
  • Have had radiation therapy within two weeks before starting the study.
  • Have received a live vaccine within 30 days before starting the study.
  • Are participating in another study or have used an investigational device recently.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
  • Have another active cancer needing treatment in the past three years, except for certain skin cancers or cervical cancer in situ.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have an active autoimmune disease needing treatment in the past two years.
  • Have a history of lung disease needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have a history of HIV, Hepatitis B, or active Hepatitis C.
  • Have a history of active tuberculosis.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant, breastfeeding, or planning to conceive during the study and for 120 days after the last treatment.

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