Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00481845

Run by

Stanford University

People needed

1

Starts

2008-01-01

Expected to finish

2009-12-01

Last updated by the study team

2017-02-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed invasive, hormone receptor-positive (ER and/or PR positive) breast cancer
• Stage I-III breast cancer including any primary tumor ≥ 1 cm 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 yo; or < 60 yo and FSH and estradiol in the postmenopausal range, prior bilateral oophorectomy)
• Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance > 50 mL/minute (calculated by Cockcroft-Gault formula.)
• Serum bilirubin < 1.5 x ULN
• Serum potassium ≥ 4 mmol/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
• Exclusion Criteria:- Inflammatory breast cancer
• Metastatic breast cancer excluding disease in regional lymph nodes
• Inoperable disease considered irreversible with neoadjuvant endocrine therapy
• HER2-overexpressed breast cancer
• Prior chemotherapy or radiotherapy for the treatment of the current breast cancer
• Prior hormonal therapy for the treatment of the current breast cancer
• Prior surgical biopsy, lumpectomy, mastectomy for the current breast cancer
• Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
• Currently active diarrhea that may affect the ability of the patient to absorb ZD6474 or tolerate diarrhea
• Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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