Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07786428
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Triple-Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg fixed dose IV once every 3 weeks
  • Paclitaxel (Chemotherapy) — DRUG
    Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle
  • Carboplatin — DRUG
    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

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Pembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle
  • Experimental: Paclitaxel + Carboplatin
    Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND 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
  • Experimental: Pembrolizumab + Paclitaxel + Carboplatin
    Pembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle AND Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND 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

Primary Outcome Measure

Rate of Pathologic complete response (pCR) [ Time Frame: Enrollment to surgery at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Meredith Carter, MS
[email protected]
214-648-7097

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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