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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)

NCT07743190 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Carboplatin

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).

DRUG

Paclitaxcel

80 mg/m2 every week for 12 weeks.

DRUG

Pembrolizumab

200 mg every 3 weeks for 4-6 cycles (depending on response).

Sponsors & Collaborators

Principal Investigators

  • Abirami Sivapiragasam, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-03-01
Completion
2030-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743190 on ClinicalTrials.gov