NCT06371807

Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab

Immunogenicity Profile of Neoadjuvant Keytruda in Combination With Anthracycline Versus Carboplatin/PAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage, TILs-Positive, Triple-Negative Breast CanceR

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fundacao Champalimaud · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-/HER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab

Detailed description

This is a randomized, open-label, pilot study to evaluate the existence of a differential tumor immunomodulatory profile of neoadjuvant pembrolizumab in combination with paclitaxel and carboplatin vs pembrolizumab in combination with EC/AC in patients with triple negative, tumor infiltrating lymphocytes (TILs) enriched, early breast cancer to allow the optimization of future de-escalation strategies. There will be crossover between treatment arms when moving from the neoadjuvant to adjuvant treatment period for completion of standard chemotherapy plus pembrolizumab. The chemotherapy regimen included in this study is built upon previous studies of pembrolizumab plus chemotherapy. The synergistic effect of different chemotherapy backbone and pembrolizumab will be studied as part of a 2-arm study: Arm 1: (KXCb - PA\[E\]C): Pembrolizumab (K) every 3 weeks (Q3W) + paclitaxel (X) + carboplatin (Cb) once weekly (QW) for 4 cycles in the neoadjuvant setting followed by pembrolizumab + doxorubicin or epirubicin (A or E) + cyclophosphamide (C) for 4 cycles followed by pembrolizumab every 6 weeks for 5 cycles (total of 1 year of pembrolizumab) in the adjuvant setting. Arm 2: (KPA\[E\]C - KXCb): Pembrolizumab + doxorubicin or epirubicin (A or E) + cyclophosphamide (C) for 4 cycles in the neoadjuvant setting followed by pembrolizumab (K) every 3 weeks (Q3W) + paclitaxel (X) + carboplatin (Cb) once weekly (QW) for 4 cycles followed by pembrolizumab every 6 weeks for 5 cycles (total of 1 year of pembrolizumab) in the adjuvant setting. In case of clinical evidence of non-pCR, i.e., biopsy proven residual disease after the neoadjuvant phase, patients can proceed to the crossover part of the adjuvant phase before surgery (i.e., 4 cycles of chemotherapy plus pembrolizumab) receiving the remaining administrations of pembrolizumab after surgery.

Conditions

• Early Breast Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab injection	(KXCb - PA\[E\]C) vs (KPA\[E\]C - KXCb) Pembrolizumab (K) + paclitaxel (X) + carboplatin (Cb) followed by pembrolizumab + doxorubicin or epirubicin (A or E) + cyclophosphamide (C) followed by pembrolizumab in the adjuvant setting vs Pembrolizumab + doxorubicin or epirubicin (A or E) + cyclophosphamide (C) followed by pembrolizumab (K) + paclitaxel (X) + carboplatin (Cb) followed by pembrolizumab in the adjuvant setting

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2026-12-01
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

3 sites across 1 country: Portugal