Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349512
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-25
Brief Title:
68Ga-FAPI-46 PETCT for Predicting Histological Response in Triple-negative Breast Cancer FAP-IT
Sponsor:
Institut Curie
Organization:
Institut Curie
Study Overview
Official Title:
68Ga-FAPI-46 PETCT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
FAP-IT
Brief Summary:
Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PETCT imaging in patients with early-stage high-risk TNBC
Detailed Description:
Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PETCT imaging in patients with early-stage high-risk TNBC
Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel carboplatin then with 4 cycles of doxorubicin or epirubicin cyclophosphamide After definitive surgery patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity
The 68Ga-FAPI-46 PETCT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PETCT scan and within 14 days before the start of treatment
Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel carboplatin then with 4 cycles of doxorubicin or epirubicin cyclophosphamide After definitive surgery patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity
The 68Ga-FAPI-46 PETCT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PETCT scan and within 14 days before the start of treatment
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 |
|---|---|---|---|
| 2023-507860-37-00 | CTIS | None | None |