Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04993014
Status:
RECRUITING
Last Update Posted:
2021-08-06
First Post:
2021-07-21
Brief Title:
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2021-07
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:
HER2Cell
Brief Summary:
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients candidate to neoadjuvant therapy with trastuzumab and pertuzumab Circulating tumor cells will be collected at neoadjuvant therapy baseline
Patients with pathological complete response will be randomized in 11 ratio for adjuvant trastuzumab arm A versus trastuzumab pertuzumab arm B in a two factorial design group A with HER2 positive CTCs and group B with HER2 negativeabsent CTCs
Patients with pathological complete response will be randomized in 11 ratio for adjuvant trastuzumab arm A versus trastuzumab pertuzumab arm B in a two factorial design group A with HER2 positive CTCs and group B with HER2 negativeabsent CTCs
Detailed Description:
Patients with HER2 positive breast cancer hormone receptors positive or negative which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included
Blood samples will be collected at baseline before neoadjuvant start for the analysis of CTCs and its positivity for HER2 by IHC and ISH
Patients with pathological complete response will be included in the randomization phase of the study There will be 2 cohorts HER2 positive CTCs at baseline and HER2 negativeabsent CTCs at baseline In each cohort patients will be randomized in 11 ratio for adjuvant trastuzumab versus adjuvant trastuzumab pertuzumab
Blood samples will be collected at baseline before neoadjuvant start for the analysis of CTCs and its positivity for HER2 by IHC and ISH
Patients with pathological complete response will be included in the randomization phase of the study There will be 2 cohorts HER2 positive CTCs at baseline and HER2 negativeabsent CTCs at baseline In each cohort patients will be randomized in 11 ratio for adjuvant trastuzumab versus adjuvant trastuzumab pertuzumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None