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Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

NCT06604858 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-04-07

No results posted yet for this study

Summary

This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥10 mm and up to 25 mm by mammogram and/or ultrasound, or ≤25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg administered every three weeks intravenously on day 1 of each cycle.

DRUG

Carboplatin

Carboplatin: area under the curve (AUC) 1.5, intravenously on day 1, day 8 and day 15 of each 21-days cycle.

DRUG

Paclitaxel

Paclitaxel: 80 mg/m2, intravenously on day 1, day 8 and day 15 of each 21-days cycle.

Sponsors & Collaborators

  • Merk Sharp & Dohme España S.A.

    collaborator UNKNOWN

  • MedSIR

    lead OTHER

Principal Investigators

  • Sara A Hurvitz, MD · Head of Hematology and Oncology Division, Fred Hutchinson Cancer Center, Seattle, WA (United States)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT06604858 on ClinicalTrials.gov