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Can a biomarker spare breast cancer patients from harsh chemo?

NCT ID NCT07743190

Not yet recruiting Disease control Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial explores whether people with early-stage triple-negative breast cancer and high levels of tumor-infiltrating lymphocytes (TILs) can safely skip a class of chemotherapy drugs called anthracyclines, which are effective but can harm the heart. Participants receive 12 weeks of carboplatin, paclitaxel, and pembrolizumab before surgery. If no cancer remains after surgery, they continue with pembrolizumab alone; if cancer remains, they receive anthracycline-based chemo plus pembrolizumab. The goal is to tailor treatment intensity to each person's tumor biology, aiming to maintain effectiveness while reducing toxicity.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
A combination of carboplatin, paclitaxel, and pembrolizumab, with or without anthracycline-based chemotherapy depending on response
What this could lead to
If successful, this approach could personalize treatment for early-stage triple-negative breast cancer, reducing exposure to anthracyclines and their heart-related risks while maintaining high cure rates.
What could go wrong
This is a phase II trial with a small number of participants, so results may not be definitive. The de-escalation strategy might not be as effective as standard treatment, and there are risks from chemotherapy and immunotherapy, including immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ELEVATED TUMOR-INFILTRATING LYMPHOCYTES TRIPLE-NEGATIVE BREAST CANCER (TNBC)

Contacts and locations

Locations

  • Medical University of South Carolina Hollings Cancer Center,

    Charleston, South Carolina, 29425, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

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