RecruitingPhase 2NCT06318897

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer


Sponsor

M.D. Anderson Cancer Center

Enrollment

28 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment of pembrolizumab (immunotherapy) with carboplatin and paclitaxel (standard chemotherapy) given before surgery in patients with small, early-stage triple-negative breast cancer. The goal is to see if this combination can shrink the tumor before it is removed. **You may be eligible if...** - You have been diagnosed with early-stage triple-negative breast cancer (meaning hormone receptor-negative and HER2-negative) - Your tumor is in the T1b or T1c stage (roughly 6mm to 2cm) - You have not yet received any treatment for this breast cancer - Your general health is adequate for chemotherapy **You may NOT be eligible if...** - Your cancer is hormone receptor-positive and your doctor recommends hormonal therapy - Your cancer has spread to lymph nodes or elsewhere in the body - You have active autoimmune disease or other serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given by IV

DRUGPaclitaxel

Given by IV

DRUGPembrolizumab

Given by IV

DRUGDoxorubicin

Given by IV

DRUGCyclophosphamide

Given by IV


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06318897