Study on Preoperative Pembrolizumab and Radiation for Breast Cancer
Sponsor: Stephen Shiao
ClinicalTrials ID:NCT03366844
This clinical trial is exploring the use of pembrolizumab, an immunotherapy drug, combined with radiation therapy before standard breast cancer treatments like surgery or chemotherapy. The aim is to see if this combination can help control breast cancer more effectively.
Patient Parameters
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Program Overview
The study is testing whether pembrolizumab, given with radiation therapy to the tumor, can be safely added before standard treatments for breast cancer. Participants will receive two doses of pembrolizumab through a vein, three weeks apart, before their planned surgery or chemotherapy. During the second dose, radiation will be directed at the tumor in the breast, known as a 'tumor boost'. This is a standard part of radiation therapy for breast cancer. Surgery or chemotherapy will start about six weeks after the first dose of pembrolizumab.
Description
Breast cancer affects over a million people worldwide each year. This study focuses on high-risk types of breast cancer that may have a strong immune response, such as triple-negative breast cancer (TNBC) and certain hormone receptor-positive cancers. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. It has been approved for use in various cancers and is now being tested in combination with radiation therapy for breast cancer. The study aims to see if this combination can enhance the body's immune response to the cancer, potentially leading to better outcomes for patients.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of invasive breast cancer.
- Specific hormone receptor and HER2 status as defined by medical guidelines.
- Tumor size of at least 2 cm, as measured by standard imaging tests.
- No signs of cancer spread to distant parts of the body.
- Plan to undergo breast-conserving therapy.
- Tumor suitable for preoperative radiation therapy.
- Good overall health with a performance status score of 0 or 1.
- Meet specific blood test criteria for white blood cells, platelets, hemoglobin, kidney, and liver function.
- Negative tests for HIV, Hepatitis B, and Hepatitis C.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the study.
- Willing to follow the study schedule and procedures, including a research biopsy at Week 4.
- Provide written informed consent to participate.
Exclusion Criteria
- HER2-positive breast cancer.
- Inflammatory breast cancer.
- Conditions that prevent breast-conserving therapy or radiation.
- Cosmetic breast implants that affect breast tissue.
- Evidence of cancer spread to other parts of the body.
- Immune system disorders or use of immunosuppressive medications.
- Recent history of other cancers requiring treatment.
- Active autoimmune diseases or infections requiring treatment.
- Serious medical conditions that could interfere with the study.
- Previous treatment with certain immunotherapy drugs.
- Recent participation in other clinical trials or use of investigational drugs.
- For those in the MRI sub-study: more than four previous gadolinium contrast scans.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
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