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Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC

NCT07786428 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-26

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effectiveness of several treatment regimens for stage I triple negative breast cancer before surgery. The main question it aims to answer is if these regimens will reduce or completely remove all cancer cells before surgery.

Conditions

  • Triple-Negative Breast Cancer (TNBC)

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg fixed dose IV once every 3 weeks

DRUG

Paclitaxel (Chemotherapy)

Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle

DRUG

Carboplatin

Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Joshua Gruber, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07786428 on ClinicalTrials.gov