Study on Boserolimab with Pembrolizumab and Chemotherapy for Early Triple-Negative Breast Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06829199
This clinical trial is exploring whether adding boserolimab to the standard treatment of pembrolizumab and chemotherapy before surgery can help treat early-stage triple-negative breast cancer. The study aims to assess the safety and effectiveness of this combination and see how well patients tolerate it.
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Program Overview
The purpose of this study is to find out if combining boserolimab with the usual treatment of pembrolizumab and chemotherapy before surgery can improve outcomes for people with early-stage triple-negative breast cancer (TNBC). Researchers want to know if this combination is safe, if patients can tolerate it well, and how many patients have no signs of cancer in the tissues and lymph nodes removed during surgery.
Description
This study uses an umbrella design to test the safety, tolerability, and effectiveness of different investigational drugs in people with newly diagnosed, high-risk, early-stage triple-negative breast cancer (TNBC). The goal is to see if adding these new drugs to the standard treatment of pembrolizumab and chemotherapy can provide additional benefits.
Eligibility Criteria
Inclusion Criteria
- Have high-risk, early-stage breast cancer that has not spread to other parts of the body and has not been treated before.
- Have a tumor that is at least stage T1c with lymph node involvement or stage T2-4 with or without lymph node involvement.
- Have had a core needle biopsy to confirm the diagnosis of breast cancer within 29 days before giving consent to participate.
- Have a confirmed diagnosis of triple-negative breast cancer according to specific medical guidelines.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a heart function test showing an ejection fraction of 50% or higher.
- Have a history of exposure to certain chemotherapy drugs called anthracyclines, with specific limits on the total doses received.
Exclusion Criteria
- Have moderate to severe nerve damage (Grade 2 or higher).
- Have uncontrolled or serious heart disease.
- Have previously received treatments targeting specific immune checkpoints like PD-1, PD-L1, or CTLA-4.
- Have had any prior treatment, including radiation or surgery, for the current breast cancer diagnosis.
- Have received any previous systemic cancer treatment.
- Have had surgery to remove the primary tumor or lymph nodes before starting the study treatment.
- Have an immune deficiency or are taking long-term steroids or other immune-suppressing medications.
- Have another active cancer that has required treatment in the past 5 years.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have a history of lung inflammation requiring steroids or current lung disease.
- Have an active infection needing treatment.
- Have HIV with a history of certain related diseases.
- Have a severe allergy to pembrolizumab or any study drugs.
- Have had a tissue or organ transplant.
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