Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01705691
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2012-10-08
Brief Title:
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by AC in Women With Locally Advanced HER2-Negative Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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:
None
Brief Summary:
NSABP FB-9 is a Phase II multi-center randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide AC as neoadjuvant therapy for women with HER2-negative operable and locally advanced breast cancer stage IIb and III Patients in the control arm will receive neoadjuvant weekly paclitaxel WP followed by AC The primary aim of the study is to determine the pathologic complete response ypCR in breast and axillary lymph nodes following completion of neoadjuvant therapy The secondary aims include determination of the ypCR in axillary nodes clinical complete response ycCR rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy two-year recurrence-free interval two-year overall survival and toxicity of the neoadjuvant regimens
Detailed Description:
Patients will be randomized to one of two neoadjuvant therapy regimens Patients in Arm 1 will receive WP 80 mgm2 for 12 doses followed by standard AC every 21 days for 4 cycles Patients in Arm 2 will receive 4 cycles of eribulin 14 mgm2 on days 1 and 8 of a 21-day cycle followed by standard AC every 21 days for 4 cycles As soon as possible following recovery from chemotherapy the patient will have either lumpectomy or mastectomy and axillary staging
In both arms clinical response will be assessed by physical exam on day 1 of each study therapy cycle MRI of the breast is required within 4 weeks prior to randomization and following completion of eribulin or WP before starting AC Following recovery from surgery patients will receive radiation therapy and hormonal therapy as clinically indicated Other postoperative therapies are prohibited
Patients will be randomized to the control arm Arm 1 and to the investigational arm Arm 2 in a 12 ratio The sample size will be up to 50 patients with about 30 patients in Arm 2 and about half that number in Arm 1 Accrual is expected to occur over 15 months
In both arms clinical response will be assessed by physical exam on day 1 of each study therapy cycle MRI of the breast is required within 4 weeks prior to randomization and following completion of eribulin or WP before starting AC Following recovery from surgery patients will receive radiation therapy and hormonal therapy as clinically indicated Other postoperative therapies are prohibited
Patients will be randomized to the control arm Arm 1 and to the investigational arm Arm 2 in a 12 ratio The sample size will be up to 50 patients with about 30 patients in Arm 2 and about half that number in Arm 1 Accrual is expected to occur over 15 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None