NCT06407310

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

Phase II Open-label, Single-arm Trial of Neoadjuvant Pembrolizumab With Carboplatin and Paclitaxel in Triple-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Tel Aviv Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The cure rate of stage I and II triple-negative breast cancer treated with anthracycline-based chemotherapy is high but comes at the price of substantial toxicity. 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 and immune effects 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

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2024-05-09
• Last updated: 2024-05-09