Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-09-19
Brief Title:
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2 Early Breast Cancer Undergoing HER2 Double-Blockade
Sponsor:
Latin American Cooperative Oncology Group
Organization:
Latin American Cooperative Oncology Group
Study Overview
Official Title:
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2 Early Breast Cancer Undergoing HER2 Double-Blockade
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
CHERRY-PICK
Brief Summary:
This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO pertuzumab and trastuzumab without chemotherapy The approach involves utilizing specific biomarkers HR and HER2 IHC status to select participants whose tumors strongly rely on the HER2 pathway potentially benefiting from a HER2-targeted approach without chemotherapy concurrently
Detailed Description:
This is a nonrandomized phase II single arm study to assess de-escalation of chemotherapy in participants with HER2-positive early breast cancer undergoing neoadjuvant therapy with PHESGO Participants will be evaluated by central laboratory review for confirmation of selected biomarkers pre-screening Participants who meet the biomarker assessment criteria will follow the eligibility criteria assessment Participants with HER2 positive disease that meet the eligibility criteria will be treated with neoadjuvant PHESGO
A baseline PETCT will be performed prior to start of PHESGO treatment All participants will receive fixed-dose subcutaneous formulation with pertuzumab and trastuzumab PHESGO every 21 days for 3 cycles to evaluate PETCT response After the 3rd cycle participants achieving PETCT response defined in this trial as 40 reduction in the SUVMax as calculated by the formula SUVbaseline SUVresponseSUVbaseline will continue treatment with PHESGO for 5 additional cycles completing 8 neoadjuvant cycles of PHESGO Participants without PETCT response after 3rd cycle will be out of study and will receive treatment and surgery according to institutional standard of care For this cohort of participant data regarding treatment received pCR status and outcomes will be collected
Definitive breast cancer surgery will be performed after the 8th cycle of therapy After surgery participants will receive adjuvant treatment according to their response Participants achieving pCR will receive PHESGO alone as adjuvant treatment to complete a total of one year of therapy thus receiving 10 cycles of adjuvant PHESGO Participants not achieving pCR will receive one of two adjuvant therapy options as per investigators choice 1 14 cycles of trastuzumab emtansine T-DM1 or 2 investigators choice chemotherapy regimen up to 6 cycles plus 10 cycles of PHESGO Disease status and survival data collection will be abstracted from medical records for up to 5 years after surgery
Participants will be followed for recurrence and survival data with abstraction of data from medical records every 3 months in first year after surgery every 4 months in second and third years and then annually until five years Medical procedures and therapies in the follow-up period are not a formal investigational part of this clinical trial and therefore will be performed according to the institutional standard of care
A baseline PETCT will be performed prior to start of PHESGO treatment All participants will receive fixed-dose subcutaneous formulation with pertuzumab and trastuzumab PHESGO every 21 days for 3 cycles to evaluate PETCT response After the 3rd cycle participants achieving PETCT response defined in this trial as 40 reduction in the SUVMax as calculated by the formula SUVbaseline SUVresponseSUVbaseline will continue treatment with PHESGO for 5 additional cycles completing 8 neoadjuvant cycles of PHESGO Participants without PETCT response after 3rd cycle will be out of study and will receive treatment and surgery according to institutional standard of care For this cohort of participant data regarding treatment received pCR status and outcomes will be collected
Definitive breast cancer surgery will be performed after the 8th cycle of therapy After surgery participants will receive adjuvant treatment according to their response Participants achieving pCR will receive PHESGO alone as adjuvant treatment to complete a total of one year of therapy thus receiving 10 cycles of adjuvant PHESGO Participants not achieving pCR will receive one of two adjuvant therapy options as per investigators choice 1 14 cycles of trastuzumab emtansine T-DM1 or 2 investigators choice chemotherapy regimen up to 6 cycles plus 10 cycles of PHESGO Disease status and survival data collection will be abstracted from medical records for up to 5 years after surgery
Participants will be followed for recurrence and survival data with abstraction of data from medical records every 3 months in first year after surgery every 4 months in second and third years and then annually until five years Medical procedures and therapies in the follow-up period are not a formal investigational part of this clinical trial and therefore will be performed according to the institutional standard of care
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 |
|---|---|---|---|
| ML44079 | OTHER_GRANT | Roche Pharma AG | None |