Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03329378
Status:
TERMINATED
Last Update Posted:
2023-08-22
First Post:
2017-10-30
Brief Title:
Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense DoxorubicinCyclophosphamide Followed by PaclitaxelTrastuzumabPertuzumab AC THP and DocetaxelCarboplatinTrastuzumabPertuzumab TCHP For Early Her2Neu Positive Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data Safety Monitoring Board is in agreement with the study findings so far and the stopping rule has been met which suspends the study treatment arms in March 2021
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
Determination of pathologic complete response pCR rates
Secondary Objective
Determination of cardiac toxicity as measured by composite of LVEF longitudinal strain and troponin
Breast conservation rates
Overall survival
Study Design
Approximately 34-74 patients with Her2 positive Stage II-regional IV breast cancer will be enrolled
Patients will be stratified by ERPR status
They will be randomized to ddACTHP vs TCHP
Initially 17 patients will be randomly assigned to each treatment arm
If 3 or fewer patients have a pCR then that arm will be terminated and no further patients will be entered on that treatment arm
If 4 or more patients obtain a pCR 20 additional patients total of 37 patients will be randomized to that treatment arm
If 11 or more patients out of 37 have a pCR the treatment will be of interest for further study
Determination of pathologic complete response pCR rates
Secondary Objective
Determination of cardiac toxicity as measured by composite of LVEF longitudinal strain and troponin
Breast conservation rates
Overall survival
Study Design
Approximately 34-74 patients with Her2 positive Stage II-regional IV breast cancer will be enrolled
Patients will be stratified by ERPR status
They will be randomized to ddACTHP vs TCHP
Initially 17 patients will be randomly assigned to each treatment arm
If 3 or fewer patients have a pCR then that arm will be terminated and no further patients will be entered on that treatment arm
If 4 or more patients obtain a pCR 20 additional patients total of 37 patients will be randomized to that treatment arm
If 11 or more patients out of 37 have a pCR the treatment will be of interest for further study
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None