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Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer

NCT06407310 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-09

No results posted yet for this study

Summary

This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.

Conditions

Interventions

DRUG

Pembrolizumab

I.V Pembrolizumab (keytruda) 200 mg every 3 weeks for 6 cycles

DRUG

Carboplatin

I.V Carboplatin at AUC 1.5 weekly for a total of 12 weeks.

DRUG

Paclitaxel

I.V Paclitaxel at 80 mg/m2 weekly for a total of 12 weeks.

Sponsors & Collaborators

  • Tel Aviv Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-04-01
Completion
2027-12-01

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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 NCT06407310 on ClinicalTrials.gov