A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)

Part of paid clinical trials in Syracuse, New York.

Sponsor
Medical University of South Carolina
Study ID
NCT07743190
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Elevated Tumor-Infiltrating Lymphocytes
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Target AUC 5 every 3 weeks for 12 weeks (depending on response) OR Target AUC 1.5 every week for 12 weeks (depending on response).
  • Paclitaxcel — DRUG
    80 mg/m2 every week for 12 weeks.
  • Pembrolizumab — DRUG
    200 mg every 3 weeks for 4-6 cycles (depending on response).

Study Details

This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on tissue review. A high TIL count is a sign the cancer may respond especially well to chemotherapy and immunotherapy together, meaning more toxic treatment may not be needed for everyone. All patients with high TILs will receive 12 weeks of chemotherapy (carboplatin and paclitaxel) with the immunotherapy drug pembrolizumab before surgery, without anthracyclines, a class of chemotherapy drugs that is effective but carries risks of heart damage and, rarely, bone marrow disorders or leukemia. Patients with no cancer found at surgery continue on pembrolizumab alone. Those with residual cancer receive anthracycline-based chemotherapy plus pembrolizumab, closer to current standard treatment. The goal is to personalize treatment, sparing anthracyclines for patients likely to do well without them while reserving stronger therapy for those who need it. The main measure of success is the pathologic complete response rate, with cancer-free survival and overall survival also assessed.

Key Dates

First listed
Aug 3, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2030

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pCR for TNBC patients high TILs treated w/neoadjuvant CPP regimen not significantly inferior
    Patients will receive carboplatin, paclitaxel, pembrolizumab. Followed by surgery. After surgery, if pCR = pembro maintenance. If no pCR = adjuvant AC/Pembro

Primary Outcome Measure

Rate of pCR in breast and axilla [ Time Frame: 60 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical UniversitySyracuseNew York13210
Erinn Mcdowell
[email protected]
Medical University of South Carolina Hollings Cancer Center,CharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321

Find similar trials in Syracuse, NY

By research site
SUNY Upstate Medical University· Syracuse, NYMedical University of South Carolina Hollings Cancer Center· Charleston, SC

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