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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony przez badanie mikroskopowe rak piersi potrójnie ujemny lub rak z niskim poziomem receptorów hormonalnych
- •Rak w stadium II lub III A/B według klasyfikacji AJCC
- •Receptory estrogenowe i progesteronowe ujemne lub niskie (≤10%)
- •HER2 ujemny (brak tego białka na komórkach raka)
- •Dobry ogólny stan zdrowia (ECOG 0-2)
- •Kobiety w wieku rozrodczym muszą używać skutecznej antykoncepcji przez badanie i 6 miesięcy po
- •Zdolność uczestniczenia w regularnych wizytach i procedurach badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
SUNY Upstate Medical University
Syracuse, United States
Medical University of South Carolina Hollings Cancer Center,
Charleston, United States
Trial contact
HCC Clinical Trials Office
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/25/2026.
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