OncoMatch/Clinical Trials/NCT07743190
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)
Is NCT07743190 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Paclitaxcel for triple negative breast cancer (tnbc).
Treatment: Carboplatin · Paclitaxcel · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≤10% positive staining by IHC)
Invasive tumor must be estrogen receptor (ER) and/or progesterone receptor (PR) negative or low, defined as ≤10% positive staining by immunohistochemistry (IHC)
Required: PR (PGR) expression (≤10% positive staining by IHC)
Invasive tumor must be estrogen receptor (ER) and/or progesterone receptor (PR) negative or low, defined as ≤10% positive staining by immunohistochemistry (IHC)
Required: HER2 (ERBB2) wild-type
HER2-negative disease, defined in accordance with current ASCO-CAP HER2 testing guidelines
Required: TILS high (≥30% by central pathology review)
Presence of tumor-infiltrating lymphocytes (TILs) <30% based on central pathology review of hematoxylin and eosin (H&E) stained slides [excluded]
Disease stage
Required: Stage II, IIIA, IIIB
Excluded: Stage INFLAMMATORY
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for current breast cancer
Prior systemic therapy...for current breast cancer
Cannot have received: radiation therapy for current breast cancer
Prior...radiation therapy...for current breast cancer
Cannot have received: definitive surgery for current breast cancer
Prior...definitive surgery for current breast cancer
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or any other T-cell co-inhibitory or co-stimulatory agents
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL (without transfusion or erythropoietin support within 14 days prior to testing); leukocytes ≥3,000/μL; ANC ≥1,500/μL; platelet count ≥100,000/μL
Kidney function
Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min/1.73 m² by Cockcroft-Gault formula (patients with CrCl 30-50 mL/min may be enrolled at PI discretion)
Liver function
AST (SGOT) and ALT (SGPT) ≤3 × ULN; total bilirubin ≤1.5 × ULN (≤5 × ULN if Gilbert's syndrome)
Cardiac function
LVEF ≥50% by ECHO or MUGA scan
Adequate hematologic and organ function as defined by the following: Hemoglobin ≥9.0 g/dL...; AST (SGOT) and ALT (SGPT) ≤3 × ULN...; Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min/1.73 m²...; LVEF ≥50% by ECHO or MUGA scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- SUNY Upstate Medical University · Syracuse, New York
- Medical University of South Carolina Hollings Cancer Center, · Charleston, South Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07743190 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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