Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371807
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-12
Brief Title:
Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab
Sponsor:
Fundacao Champalimaud
Organization:
Fundacao Champalimaud
Study Overview
Official Title:
Immunogenicity Profile of Neoadjuvant Keytruda in Combination With Anthracycline Versus CarboplatinPAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage TILs-Positive Triple-Negative Breast CanceR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KEYPARTNER
Brief 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 ECAC 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 - PAEC 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 KPAEC - 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 ie biopsy proven residual disease after the neoadjuvant phase patients can proceed to the crossover part of the adjuvant phase before surgery ie 4 cycles of chemotherapy plus pembrolizumab receiving the remaining administrations of pembrolizumab after surgery
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 - PAEC 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 KPAEC - 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 ie biopsy proven residual disease after the neoadjuvant phase patients can proceed to the crossover part of the adjuvant phase before surgery ie 4 cycles of chemotherapy plus pembrolizumab receiving the remaining administrations of pembrolizumab after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None