Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04130152
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2019-10-14
Brief Title:
Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
SOLTI Breast Cancer Research Group
Study Overview
Official Title:
Palbociclib in Combination With Letrozole in Patients With Hormone Receptor HR PositiveHuman Epidermal Growth Factor Receptor 2 HER2 Negative Residual Disease After Standard Neoadjuvant Chemotherapy PROMETEO II
Status:
COMPLETED
Status Verified Date:
2022-06
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:
PROMETEO II
Brief Summary:
PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HRHER2-negative operable breast cancer BC patients with residual disease after neoadjuvant chemotherapy NAC and help to identify biomarkers for better patient selection
Detailed Description:
This is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HRHER2-negative operable BC patients with residual disease after NAC and help to identify biomarkers for better patient selection
The primary endpoint will be the Complete Cell Cycle Arrest CCCA determined by Ki6727 centrally assessed at surgery after 4 weeks of palbociclib and letrozole
Tumor measurement will be performed by ultrasound US for disease evaluation and confirmation of residual disease will be performed at screening at the end of NAC The biopsy after chemotherapy will only be done after confirmation of residual disease by US Ki67 5 after NAC by local determination will be necessary to be included in the study
Patients will be administered palbociclib at a dose of 125 mg once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle and letrozole oral 25 mg per day continuously one cycle of treatment
After the finalization of the neoadjuvant treatment patients will undergo surgery Surgery specimens will be collected for histological examination and biomarker analysis
The end of the study is defined as the date of post-surgery visit and will take place 4 weeks - 7days after the surgery in order to monitor the patients safety and collect the surgery information
The primary endpoint will be the Complete Cell Cycle Arrest CCCA determined by Ki6727 centrally assessed at surgery after 4 weeks of palbociclib and letrozole
Tumor measurement will be performed by ultrasound US for disease evaluation and confirmation of residual disease will be performed at screening at the end of NAC The biopsy after chemotherapy will only be done after confirmation of residual disease by US Ki67 5 after NAC by local determination will be necessary to be included in the study
Patients will be administered palbociclib at a dose of 125 mg once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle and letrozole oral 25 mg per day continuously one cycle of treatment
After the finalization of the neoadjuvant treatment patients will undergo surgery Surgery specimens will be collected for histological examination and biomarker analysis
The end of the study is defined as the date of post-surgery visit and will take place 4 weeks - 7days after the surgery in order to monitor the patients safety and collect the surgery information
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 |
|---|---|---|---|
| 2019-001275-36 | EUDRACT_NUMBER | None | None |