Trial ID or NCT#

NCT01216176

Status

not recruiting iconNOT RECRUITING

Purpose

The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug efficacy.

Official Title

A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Robert W. Carlson
Frederick M. Dirbas, MD
Frederick M. Dirbas, MD
Surgical oncologist, Breast surgeon
Associate Professor of Surgery (General Surgery)
Allison W. Kurian, M.D., M.Sc.
Allison W. Kurian, M.D., M.Sc.
Medical oncologist, Breast specialist, Cancer geneticist
Professor of Medicine (Oncology) and of Epidemiology and Population Health
Mark Pegram
Mark Pegram
Medical oncologist, Breast specialist
Susy Yuan-Huey Hung Professor

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CONTACT

CCTO
(650) 498-7061