Actively Recruiting
NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
Led by Medical University of South Carolina · Updated on 2026-05-06
43
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed triple-negative breast cancer or hormone receptor-low invasive breast carcinoma, clinical Stage II or IIIA/B
- Tumor larger than 1 cm in the breast, with or without axillary involvement
- Female or male, age 18 years or older
- ECOG performance status of 0 to 2
- Medically fit for curative-intent breast surgery
- No prior chemotherapy, immunotherapy, radiation, or surgery for current breast cancer (biopsies allowed)
- Ability to be followed by cardiologist or primary care physician for heart condition management
- Adequate blood, kidney, liver, and coagulation function at screening
- Breast and axillary imaging within 6 weeks prior to registration
- Pathological confirmation of metastatic lymph nodes if abnormal on imaging
- Staging scans to exclude metastatic disease if indicated
- Baseline peripheral neuropathy grade 2 or lower
- Use of highly effective contraception for individuals of childbearing potential during and 6 months after study
- Ability and willingness to comply with all study procedures and provide informed consent
- HIV patients must be on effective therapy with undetectable viral load within 6 months
- Hepatitis B and C patients must have undetectable viral load or be cured if treated
- Ineligible for anthracycline treatment due to cardiomyopathy, severe valvular disease, prior anthracycline exposure, high dose chest radiation, recent heart events, high risk for heart failure, patient choice, or other medical conditions
You will not qualify if you...
- Participation in another investigational study or use of investigational device within 4 weeks prior to study
- Diagnosis of metastatic or inflammatory breast cancer
- Unfit for curative surgery
- Other malignancies within last 5 years (except certain skin or in situ cancers)
- Allergy to carboplatin or paclitaxel or similar compounds
- Recovery not adequate from major surgery before study start
- Live vaccine within 30 days before study treatment
- Immunodeficiency or use of immunosuppressive therapy exceeding limits
- Active autoimmune disease requiring systemic treatment in past year
- History of solid organ transplant
- History or current non-infectious pneumonitis requiring high-dose steroids
- Active bacterial infection needing systemic therapy
- Psychiatric or substance abuse disorders interfering with study
- Pregnant or breastfeeding women, or positive pregnancy test within 24 hours before study
- Uncontrolled high blood pressure or symptomatic arrhythmia at screening
- Ejection fraction less than 25% at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
A
Abirami Sivapiragasam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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