Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455039
Status:
WITHDRAWN
Last Update Posted:
2023-08-14
First Post:
2007-03-30
Brief Title:
INST 0514C- Biologic Correlative Study Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
INST 0514C- A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients Biologic Correlative Study
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This is a duplicate record and the sponsor has submitted under NCT00206427
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with large tumors in order to render them operable for mastectomy or in some cases for lumpectomy and radiation therapy Building on this theme several large hormonal therapies are extensively investigated in the neoadjuvant setting together with biologic correlates for response and resistance As a further extension neoadjuvant therapies with biologic agents are now too being investigated for biologic evidence of efficacy before large-scale clinical trials of thousands of patients are embarked on The neoadjuvant setting is especially attractive for these studies for several reasons including early assessment of response to therapy biopsiable access to the primary tumor and considerable reduced sample sizes compared to those required in the adjuvant setting In addition clinical response to neoadjuvant chemotherapy is a validated surrogate marker for improved survival It may be used to test the overall efficacy of neoadjuvant treatment regimens and mirrors the effect of therapy on micrometastases setting In a recent study good clinical response to neoadjuvant chemotherapy was the only independent variable by multivariate analysis associated with decreased risk of death
GW572016 is a new and promising dual tyrosine kinase inhibitor against HER12 Hundreds of patients were treated in phase I and II studies world-wide and results indicate that this reversible oral small molecule is generally well-tolerated Studies of neoadjuvant Trastuzumab indicate that HER2 interference leads to significant tumor regression even after 3 weeks of monotherapy We aim to extend these findings with a novel agent GW572016 that may be more effective especially from its in vitro data and to discover the true response rate to inhibiting HER12 signal transduction in breast cancer patients
GW572016 is a new and promising dual tyrosine kinase inhibitor against HER12 Hundreds of patients were treated in phase I and II studies world-wide and results indicate that this reversible oral small molecule is generally well-tolerated Studies of neoadjuvant Trastuzumab indicate that HER2 interference leads to significant tumor regression even after 3 weeks of monotherapy We aim to extend these findings with a novel agent GW572016 that may be more effective especially from its in vitro data and to discover the true response rate to inhibiting HER12 signal transduction in breast cancer patients
Detailed Description:
See above
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?:
False
Is an FDA AA801 Violation?:
None