Study on Pembrolizumab with Carboplatin and Paclitaxel Before Surgery for Early Stage Triple Negative Breast Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06318897
This clinical trial is testing a combination of pembrolizumab, carboplatin, and paclitaxel given before surgery to see if it can effectively treat early stage triple negative breast cancer. The study also looks at the safety of this treatment and its impact on patients' health and quality of life.
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Program Overview
The purpose of this study is to evaluate how well a combination of pembrolizumab, carboplatin, and paclitaxel works in treating patients with early stage triple negative breast cancer (TNBC) before surgery. Researchers aim to determine the rate of complete cancer disappearance and assess the safety of this treatment. The study will also explore how long patients remain free of invasive disease and their overall survival, as well as any molecular markers that might predict treatment response.
Description
This study involves using a combination of pembrolizumab, carboplatin, and paclitaxel before surgery in patients with early stage triple negative breast cancer (TNBC). The main goal is to see if this treatment can completely eliminate cancer in some patients. Researchers will also monitor the safety and side effects of the treatment.
Participants will receive four cycles of the treatment before surgery. The study will track the rate of complete cancer disappearance, known as pathological complete response (pCR). Additionally, the study will assess the safety of the treatment by recording any side effects that occur.
Researchers will also explore how long patients remain free of invasive disease and their overall survival. They will look for any molecular markers that might indicate how well a patient will respond to the treatment. Patient-reported outcomes will also be evaluated to understand the impact of the treatment on quality of life.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of triple negative breast cancer (TNBC), which means the cancer is negative for estrogen, progesterone, and HER2 receptors.
- Cancer must be at an early stage (Stage 1, T1b-T1c, N0, M0) and confirmed by a biopsy.
- Must be at least 18 years old.
- Male participants must agree to use contraception during the study and for 120 days after the last dose.
- Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for 120 days after the last dose.
- Must have recovered from any side effects of previous cancer treatments to a mild level.
- Must provide a tumor tissue sample for analysis.
- Must have a good performance status, meaning they are fully active or have some restrictions in physically strenuous activity.
- Must have adequate organ function based on specific blood tests.
- Non-English speakers can participate if interpretation is available.
- HIV-positive participants can join if their condition is well-controlled.
- Participants with hepatitis B or C can join if their viral load is undetectable and they are on appropriate antiviral therapy.
Exclusion Criteria
- Have Stage 2, 3, or 4 triple negative breast cancer.
- Have hormone receptor-positive or HER2-positive breast cancer.
- Are pregnant or breastfeeding.
- Have received certain cancer treatments or vaccines recently.
- Have a history of severe allergic reactions to study drugs.
- Have active autoimmune diseases requiring treatment.
- Have active infections or other serious medical conditions.
- Have other cancers that are progressing or have required treatment in the past 3 years.
- Have active brain metastases or cancer in the brain lining.
- Have had a recent organ transplant or have contraindications to doxorubicin therapy.
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