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RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen.
Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for
their growth. It is not yet known whether gefitinib is more effective when combined with
anastrozole or fulvestrant in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with
anastrozole works compared to giving gefitinib together with fulvestrant in treating
postmenopausal women with recurrent or metastatic breast cancer.
Active, not recruiting
Ages:18 and older
Inclusion criteria: - Histologically confirmed adenocarcinoma of the breast (Recurrent or metastatic disease) - Measurable disease - Patients with available tissue blocks from either the primary or metastatic site must submit the tissue for epidermal growth factor receptor analysis - Estrogen and/or progesterone receptor positive - Age>=18 - Female - Postmenopausal, defined by 1 of the following: - Prior bilateral oophorectomy or bilateral ovarian irradiation - No menstrual period for at least 12 months NOTE: If age 55 and under and on tamoxifen within the past 6 months, must have an estradiol level in the postmenopausal range - ECOG performance status of 0-2 - Adequate hematopoietic, hepatic, renal functions defined by the following within 2 weeks prior to randomization: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - Serum glutamic-pyruvic transaminase (ALT) and Serum glutamic-oxaloacetic (AST) no greater than 2.5 times ULN (5 times ULN if liver metastases are present) - International normalized ratio of prothrombin time (INR), prothrombin time (PT), and partial thromboplastin time (PTT) normal - Creatinine clearance at least 30 mL/min - More than 3 weeks since prior trastuzumab (Herceptin®) - More than 3 weeks since prior chemotherapy - More than 3 months since prior luteinizing hormone-releasing hormone agonists or antagonists (patients 55 years old and under) - Recovered from prior radiotherapy - Concurrent radiotherapy to painful sites of bony disease or areas of impending fracture is allowed provided the following conditions are met: - Therapy was initiated prior to study entry - Sites of measurable disease outside the radiotherapy port are available for disease evaluation - Concurrent bisphosphonates for hypercalcemia or bone metastases are allowed Exclusion Criteria: - Pregnant or nursing - Untreated ocular inflammation or infection - Medical or psychiatric condition that would preclude study compliance, ability to give informed consent, or assessment of response or anticipated toxic effects - History of central nervous system (CNS) metastasis - Other invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Contraindication to intramuscular injections - More than 2 prior chemotherapy regimens for metastatic disease - Prior hormonal therapy for metastatic disease - Prior estrogen receptor down-regulators (e.g., fulvestrant) in the adjuvant setting - Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, or aminoglutethimide) in the adjuvant setting - Prior agents that target epidermal growth factor receptors - Other concurrent hormonal therapy - Concurrent chemotherapy - Concurrent trastuzumab - Concurrent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (e.g., ketoconazole, erythromycin, or verapamil) - Concurrent anticoagulants, except for thrombotic events in patients in arm I - Concurrent medications that would alter the pharmacokinetics of gefitinib (e.g., phenytoin, carbamazepine, phenobarbital, rifampin, Hypericum perforatum [St. John's wort], oxcarbazepine, rifapentine, modafinil, and griseofulvin)
Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00057941
Not Accepting Healthy Volunteers