Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404066
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2006-11-22
Brief Title:
Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide - Docetaxel With Lapatinib in Stage IIIII Her2Neu Breast Cancer
Sponsor:
George Albert Fisher
Organization:
Stanford University
Study Overview
Official Title:
Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage IIIII Her2Neu Positive Breast Cancer With Sequential AC - Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 Lapatinib Followed by 1 Year Adjuvant Trastuzumab
Status:
COMPLETED
Status Verified Date:
2017-11
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:
This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide AC followed by standard every 3 week docetaxel and GW572016 lapatinib for neoadjuvant treatment of Her2neu positive stage IIIII breast cancer The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates
Detailed Description:
Lapatinib acts as a dual inhibitor of both epidermal growth factor receptor EGFR and ErbB-2 Her2neu tyrosine kinase activity EGFR and ErbB2 receptors are frequently over-expressed or altered in human cancers including breast cancer This study plans to determine the antitumor activity of this regimen and its effectiveness preventing tumor growth and spread
Neoadjuvant chemotherapy which achieves pathologic complete responses pCR has been shown to predict improved long-term survival and serves as a surrogate for clinical outcome By using this primary endpoint we can obtain statistical data with smaller patient numbers and at a lower overall cost Additionally we hope to correlate clinical and radiologic outcomes with gene expression data
Neoadjuvant chemotherapy which achieves pathologic complete responses pCR has been shown to predict improved long-term survival and serves as a surrogate for clinical outcome By using this primary endpoint we can obtain statistical data with smaller patient numbers and at a lower overall cost Additionally we hope to correlate clinical and radiologic outcomes with gene expression data
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BRSADJ0002 | OTHER | OnCore | None |