Doctors want to know if combining Arimidex (anastrozole) with Faslodex (fulvestrant) will be an effective treatment for breast cancer. Doctors also want to know if these drugs cause changes in the patient's tumor. By using special tests on the tumor, doctors can see the changes that occur with the treatment. By looking at the changes that happen to the tumor because of these drugs, the doctors can try to improve the treatments for breast cancer in the future.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00570323.
PRIMARY OBJECTIVES:
I. To determine the efficacy of primary breast cancer, as measured by decrease in proliferation (Ki-67), to the combination of ARIMIDEX, and FASLODEX at high dose.
SECONDARY OBJECTIVES:
I. To study molecular changes in response to treatment.
II. To correlate changes in Ki67 with clinical response.
III. To determine the pathologic response rate.
IV. To assess the tolerability and safety of the combination regimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive anastrozole orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive anastrozole PO QD and fulvestrant intramuscularly (IM) on days 1, 14, and 28, 56, 84, and 112.
In both arms, patients achieving clinical response or stable disease undergo surgery on day 112.
After completion of study treatment, patients are followed up at 140 days.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorMothaffar Fahed Rimawi
