Ignite Creation Date:
2024-05-06 @ 3:37 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02339532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2014-12-14
Brief Title:
Neoadjuvant Phase II Trial in Patients With T1c Operable HER2-positive Breast Cancer According to TOP2A Status
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Neoadjuvant Phase II Trial Combining 3 FEC 100 Followed by 3 Docetaxel Associated With Trastuzumab Plus Pertuzumab or 6 Docetaxel Carboplatin Associated With Trastuzumab Plus Pertuzumab According to TOP2A Status in Patients With T1c Operable HER2-positive Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
NeoTOP
Brief Summary:
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen FEC 100 - TAXOTERE - HERCEPTIN - PERTUZUMAB and a non anthracycline-based regimen TAXOTERE - CARBOPLATINE - HERCEPTIN - PERTUZUMAB according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression
A very important objective of the study will be the evaluation of biomarkers that predict response to treatment
A very important objective of the study will be the evaluation of biomarkers that predict response to treatment
Detailed Description:
In this phase II study we propose a treatment strategy that not only takes advantage of the complementary action of trastuzumab and pertuzumab but also the relevance of an anthracycline-based regimen Indeed besides the cardiac toxicity that can be induced by these three agents anthracycline chemotherapy may not confer benefit to all patients
The underlying scientific hypothesis is based on data from the NEOSPHERE neoadjuvant trial showing that addition of pertuzumab to trastuzumab plus docetaxel improved the pCR rate 46 versus 29 without pertuzumab in T2-T3 tumors Therefore we hypothesize that for smaller tumors T1c the pCR rate should be higher on the order of 60 in patients with the coamplification with anthracycline therapy and 55 for the group without coamplification without anthracycline therapy The sample size of 90 patients 45 per group planned for the phase II study will allow 15 precision with the expected pCR rates of 60 95CI 45-75 for patients with coamplification and 55 95CI 40-70 for those without coamplification In addition exploratory analyses will aim to identify predictive markers of pCR in order to target biologically defined subpopulations in which pCR rates might even be higher
The underlying scientific hypothesis is based on data from the NEOSPHERE neoadjuvant trial showing that addition of pertuzumab to trastuzumab plus docetaxel improved the pCR rate 46 versus 29 without pertuzumab in T2-T3 tumors Therefore we hypothesize that for smaller tumors T1c the pCR rate should be higher on the order of 60 in patients with the coamplification with anthracycline therapy and 55 for the group without coamplification without anthracycline therapy The sample size of 90 patients 45 per group planned for the phase II study will allow 15 precision with the expected pCR rates of 60 95CI 45-75 for patients with coamplification and 55 95CI 40-70 for those without coamplification In addition exploratory analyses will aim to identify predictive markers of pCR in order to target biologically defined subpopulations in which pCR rates might even be higher
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