Anastrozole With or Without Fulvestrant in Treating Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

Inclusion Criteria

• Postmenopausal status, defined as any one of the following criteria: * Documented history of bilateral oophorectomy * Age 60 years or more * Age 45 to 59 and satisfying one or more of the following criteria: ** Amenorrhea for at least 12 months and intact uterus ** Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: *** Patients who have had a hysterectomy *** Patients who have received hormone replacement
• Patients must have histologically confirmed invasive breast cancer with a primary tumor >= 2 cm in greatest dimension as measured by clinical or radiologic examination
• Estrogen receptor and/or progesterone receptor positive disease
• Patients must not have received any prior treatment for current or newly diagnosed breast cancer
• Patients must have not received previous treatment with any of the study medications or similar drugs
• No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years
• World Health Organization (WHO) performance status of 0, 1, or 2
• Serum creatinine within 3 times the upper limits of normal
• Total bilirubin within 3 times the upper limits of normal
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times the upper limits of normal
• Alkaline phosphatase within 3 times the upper limits of normal
• White blood cells (WBC) > 3.0 ml
• Platelets (PLT) > 75,000/ul
• Hemoglobin (Hb) > 9 gm/l
• Willing to undergo breast core biopsies as required by the study protocol
• Ability to understand and sign a written informed consent for participation in the trial
• Life expectancy of at least 1 year

Exclusion Criteria

• Premenopausal status
• Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ
• Patients with brain metastasis
• WHO performance status of 3 or 4
• As judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
• Concurrent treatment with estrogens or progestins; patients must stop these drugs at least two weeks prior to study entry
• Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
• Platelet count less than 75,000
• In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections
• History of hypersensitivity to castor oil
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
• Patients with recurrent breast cancer; patients with contralateral second primary breast cancers are eligible