RecruitingPhase 2NCT06845319

NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients

NeoCARD: A Response-Adapted Phase II Study of Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients With Cardiomyopathy or Elevated Risk of Cardiotoxicity


Sponsor

Medical University of South Carolina

Enrollment

43 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm Phase II study to assess the efficacy of a 12-18 week neoadjuvant carboplatin, paclitaxel, and pembrolizumab (CPP) regimen in a response-adaptive manner for triple-negative breast cancer (TNBC) patients who are ineligible for anthracycline-based therapy due to underlying cardiac conditions.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy-plus-immunotherapy combination that avoids the use of anthracyclines (a class of chemotherapy drugs that can damage the heart) in people with triple-negative breast cancer (TNBC), a fast-growing type of breast cancer that lacks the three most common hormone receptors. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Stage II or IIIA/B triple-negative breast cancer - Your tumor is larger than 1 cm (with or without spread to lymph nodes) - You are otherwise healthy enough for cancer surgery - You have a cardiologist or primary care doctor available to monitor your heart health **You may NOT be eligible if...** - You have inflammatory breast cancer - You have prior chemotherapy or radiation for this cancer - You have significant heart disease that can't be managed - 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

Carboplatin target AUC 5 every 3 weeks for 12-18 weeks OR target AUC 1.5 every week for 12-18 weeks (per investigator's choice).

DRUGPaclitaxel

80mg/m2 weekly

DRUGPembrolizumab

200 mg every 3 weeks for 4 cycles


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06845319


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