Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472583
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-21
Brief Title:
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Maria Sklodowska-Curie National Research Institute of Oncology
Study Overview
Official Title:
A Phase II Study of Preoperative Stereotactic Radiation Therapy Boost Combined With Short-course Immunotherapy Pembrolizumab Versus Placebo Randomized Double-blind and Standard Chemiotherapy in Patients With Newly Diagnosed HER2-negative Nonmetastatic Breast Cancer With Lack of Early Metabolic Response in 18- fluorodeoxyglucoseFDG-PETCT After 1st Chemoterapy Cycle
Status:
RECRUITING
Status Verified Date:
2024-04
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:
BREAST-BOOSTER
Brief Summary:
The goal of the study is to assess the safety and effectiveness of the combination of anti-PD1 immunotherapy pembrolizumab and radiotherapy in the preoperative treatment of HER2-negative breast cancer resistant to classical chemotherapy
The subject of the intervention will be
1 Randomly assigned in a 21 ratio and double-blinded addition of pre-operative immunotherapy with pembrolizumab or placebo to standard chemotherapy
2 Addition of preoperative radiotherapy boost delivered with a CyberKnife radiosurgery system concomitantly with the use of paclitaxel - carboplatin and pembrolizumab placebo
The subject of the intervention will be
1 Randomly assigned in a 21 ratio and double-blinded addition of pre-operative immunotherapy with pembrolizumab or placebo to standard chemotherapy
2 Addition of preoperative radiotherapy boost delivered with a CyberKnife radiosurgery system concomitantly with the use of paclitaxel - carboplatin and pembrolizumab placebo
Detailed Description:
The study aims to assess the safety and effectiveness of the combination of anti-PD1 PD-1 programmed cell death-1 immunotherapy pembrolizumab with radiotherapy in the preoperative treatment of triple-negative or luminal HER2-negative HER2 Human epidermal growth factor receptor 2 breast cancer stage IIAIIBIIIIV with an acceptable oligometastatic form resistant to classical chemotherapy
After screening and administration of standard induction chemotherapy the study will be conducted in a group of patients selected on the basis of lack of metabolic response after the 1st cycle of chemotherapy and the subject of the intervention will be
addition of preoperative immunotherapy with pembrolizumab or placebo to standard chemotherapy using a double-blind randomized trial in a ratio of 21 respectively
addition of a boost of preoperative robotic stereotactic radiotherapy in all patients simultaneously with the use of paclitaxel - carboplatin and pembrolizumabplacebo
After screening and administration of standard induction chemotherapy the study will be conducted in a group of patients selected on the basis of lack of metabolic response after the 1st cycle of chemotherapy and the subject of the intervention will be
addition of preoperative immunotherapy with pembrolizumab or placebo to standard chemotherapy using a double-blind randomized trial in a ratio of 21 respectively
addition of a boost of preoperative robotic stereotactic radiotherapy in all patients simultaneously with the use of paclitaxel - carboplatin and pembrolizumabplacebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504145-31-00 | CTIS | None | None |