NCT06318897

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Detailed description

Primary Objective To estimate the rate of pCR in patients with cT1b and T1cN0M0 TNBC after neoadjuvant therapy with 4 cycles of Pembrolizumab + Carboplatin + Paclitaxel. Secondary Objective To assess the safety and toxicity profile of pembrolizumab plus chemotherapy in participants receiving an anthracycline-de-escalated regimen of carboplatin, paclitaxel and pembrolizumab by recording the incidence of treatment emergent adverse events. Exploratory Objectives 1. To estimate the invasive disease-free survival (iDFS), and overall survival (OS) in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study. 2. To explore if there is a molecular signature associated with response or lack of response to therapy. 3. To evaluate patient reported outcomes of participants receiving this de-escalated regimen.

Conditions

• Stage 1 cT1b-T1cN0M0
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Given by IV
DRUG	Paclitaxel	Given by IV
DRUG	Pembrolizumab	Given by IV
DRUG	Doxorubicin	Given by IV
DRUG	Cyclophosphamide	Given by IV

Timeline

• Start date: 2024-05-29
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-03-19
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study