Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110695
Status:
COMPLETED
Last Update Posted:
2010-03-26
First Post:
2005-05-12
Brief Title:
Therapy With Abraxane and 5-Fluorouracil Epirubicin Cyclophosphamide FEC for Patients With Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel Abraxane Followed by 5-Fluorouracil Epirubicin Cyclophosphamide FEC in Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer
Detailed Description:
This is a Phase 2 non-randomized study of neoadjuvant treatment with nanoparticle albumin bound paclitaxel Abraxane every week for 12 weeks followed by 5-FU epirubicin and cyclophosphamide FEC every 3 weeks for 4 cycles in women with locally advanced breast cancer Patients with HER-2 overexpressing breast cancer may receive trastuzumab concurrently with the chemotherapy at the discretion of the investigator The primary aim of this study is to determine the pathologic complete response rate pCR of this sequential regimen
Patients who achieve clinical complete response cCR clinical partial response cPR or have resectable stable disease SD will undergo surgery Surgery will consist of modified radical mastectomy or excision of the primary tumor site with clear surgical margins accompanied by axillary staging Tumor samples taken prior to initiation of treatment will be analyzed for molecular and genetic changes which will be correlated with tumor response
Patients must have a histologically confirmed diagnosis of breast cancer without documented evidence of distant metastatic disease Patients with clinical Stage IIB T3N0 only IIIA or IIIB breast cancer will be potential candidates for this trial
Patients who achieve clinical complete response cCR clinical partial response cPR or have resectable stable disease SD will undergo surgery Surgery will consist of modified radical mastectomy or excision of the primary tumor site with clear surgical margins accompanied by axillary staging Tumor samples taken prior to initiation of treatment will be analyzed for molecular and genetic changes which will be correlated with tumor response
Patients must have a histologically confirmed diagnosis of breast cancer without documented evidence of distant metastatic disease Patients with clinical Stage IIB T3N0 only IIIA or IIIB breast cancer will be potential candidates for this trial
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