Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481845
Status:
TERMINATED
Last Update Posted:
2017-02-07
First Post:
2007-05-31
Brief Title:
Phase 2 Anastrozole and Vandetanib ZD6474 in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Randomized Phase 2 Trial of Anastrozole Combined With Novel Agent ZD6474 in the Neoadjuvant Treatment of Postmenopausal Patients With Hormone Receptor-Positive Breast Cancer
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we plan to study the combination of ZD6474 a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast cancer
Detailed Description:
The use of adjuvant chemotherapy and endocrine therapy has had a significant impact on breast cancer survival However not all patients will benefit from each of these therapies Increasing data suggests that patients with hormone receptor-positive breast cancer derive marginal benefit from the addition of adjuvant chemotherapy Identification and characterization of cellular signaling pathways active in the pathogenesis of breast cancer has lead to the development of multiple targeted therapies that hold enormous promise for patients with less toxicity than conventional chemotherapy Treatment strategies employing neoadjuvant therapy have found that pCR is predictive for ultimate outcome Due to this the use of neoadjuvant therapy has become an intense area of investigation in operable breast cancer In the IMPACT trial the aromatase inhibitor anastrozole was found to improve eligibility for breast conservation and was associated with a favorable clinical objective response after 12 weeks of therapy
In this proposed study we plan to study the combination of ZD6474 a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast cancer The two agents have non-overlapping toxicities and are both administered orally allowing for a more tolerable treatment regimen By using this combination in the neoadjuvant setting we will target the critical signaling pathways early and follow tumor responses during therapy allowing for prompt evaluation of the effectiveness of this treatment strategy Pathologic tumor specimens obtained at the time of definitive surgery will be evaluated for pathologic complete response thus adding to the body of literature By examining molecular markers such as ER PR EGFR and Ki-67 pre- and post-treatment we hope to correlate modulations in these biomarkers to response Finally using a novel second generation functional breast MRI we will investigate the ability of MRI to predict response to antiangiogenic therapy
In this proposed study we plan to study the combination of ZD6474 a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast cancer The two agents have non-overlapping toxicities and are both administered orally allowing for a more tolerable treatment regimen By using this combination in the neoadjuvant setting we will target the critical signaling pathways early and follow tumor responses during therapy allowing for prompt evaluation of the effectiveness of this treatment strategy Pathologic tumor specimens obtained at the time of definitive surgery will be evaluated for pathologic complete response thus adding to the body of literature By examining molecular markers such as ER PR EGFR and Ki-67 pre- and post-treatment we hope to correlate modulations in these biomarkers to response Finally using a novel second generation functional breast MRI we will investigate the ability of MRI to predict response to antiangiogenic therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97923 | OTHER | Stanford University Alternate IRB Approval Number | None |
| BRSADJ0008 | OTHER | None | None |