Study on High Dose Radiation Therapy with Pembrolizumab and Chemotherapy for Treating PD-L1 Positive Metastatic Triple Negative Breast Cancer

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06492759

Provider View

This clinical trial is exploring whether combining high dose radiation therapy with the immunotherapy drug pembrolizumab and chemotherapy can effectively treat patients with PD-L1 positive triple negative breast cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing a treatment that combines high dose radiation therapy with pembrolizumab, an immunotherapy drug, and chemotherapy drugs (paclitaxel, nab-paclitaxel, or carboplatin and gemcitabine) to see if it can help control PD-L1 positive triple negative breast cancer that has spread. Radiation therapy uses high energy rays to kill cancer cells. Pembrolizumab helps the immune system attack cancer cells. The chemotherapy drugs work by stopping cancer cells from growing and dividing. This combination may be effective in treating this type of breast cancer.

Description

The main goal of this study is to see if the combination of high dose radiation therapy, pembrolizumab, and chemotherapy can help patients with PD-L1 positive triple negative breast cancer live longer without the cancer getting worse. The study will also look at how well the treatment works on tumors that are not directly treated with radiation and whether the treatment causes any serious side effects.

Patients will receive radiation therapy every other day for three doses. Within 48 hours of starting radiation, they will begin receiving pembrolizumab through an IV on the first day of each treatment cycle. These cycles repeat every 21 days unless the cancer progresses or side effects become too severe. Patients will also receive one of three chemotherapy options: nab-paclitaxel, paclitaxel, or a combination of carboplatin and gemcitabine, with cycles repeating every 21 or 28 days depending on the drugs used.

Throughout the study, patients will have biopsies, CT scans, bone scans, and blood tests to monitor their response to the treatment. After completing the study treatment, patients will have follow-up visits every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with PD-L1 positive triple negative breast cancer that has spread to at least two other areas.
  • Cancer must be confirmed by a biopsy and show specific characteristics, such as being negative for certain hormone receptors and HER2.
  • Must have a PD-L1 combined positive score of 10 or higher.
  • Must have had a physical exam and imaging tests within 60 days before joining the study.
  • Must be eligible for radiation therapy, immunotherapy, and chemotherapy as determined by a doctor.
  • Must have at least one tumor that can be treated with high dose radiation.
  • Must be 18 years or older and able to provide informed consent.
  • Must have a good performance status and meet specific blood test criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.

Exclusion Criteria

  • Have received chemotherapy or targeted therapy for metastatic triple negative breast cancer before starting the study treatment.
  • Have untreated or unstable brain metastases.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Have a history of autoimmune disease requiring systemic treatment.
  • Are taking chronic steroids or immunosuppressive medications.
  • Have had a stem cell or organ transplant.
  • Have severe heart problems or infections requiring IV antibiotics.
  • Have certain lung diseases or low immune cell counts.
  • Have another active cancer requiring treatment.
  • Are pregnant or breastfeeding, or planning to conceive during the study.

Get This Program In Your Inbox

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