Randomized Phase II Trial of Anastrozole Combined With Novel Agent ZD6474 in the Neoadjuvant Treatment of Postmenopausal Patients With Hormone Receptor-Positive Breast Cancer
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : ZD6474
- drug : Anastrozole
- drug : Magnevist
Phase: Phase 2
Ages Eligible For Study:
- Histologically confirmed invasive, hormone receptor-positive (ER and/or PR positive) breast cancer - Stage I-III breast cancer including any primary tumor >= 1cm by ultrasound - Diagnosis by core needle biopsy with placement of metallic clip at tumor site - Sentinel lymph node biopsy (US-guided FNA may be substituted if palpable axillary lymphadenopathy) - Evaluation by a surgeon to determine eligibility for breast conservation - Postmenopausal status (age >= 60, age < 60 and FSH and estradiol in the postmenopausal range, prior bilateral oophorectomy) - Serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/minute (calculated by Cockcroft-Gault formula.) - Serum bilirubin < 1.5 x ULN - Serum potassium must not be less than 4mmol/L (supplementation allowed) - Serum calcium or magnesium within normal range (supplementation allowed) - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 2.5 x ULN or alkaline phosphatase (ALP) <= 2.5 x ULN - ECOG Performance Status 0,1,2 - ECG QTc < 480 msec - Measurable disease - Written, informed consent