DISEASE CHARACTERISTICS:

• 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
• No history of CNS metastasis

• Hormone receptor status:

  • Estrogen and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• 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

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
• INR, PT, and PTT normal

Renal

• Creatinine clearance at least 30 mL/min

Other

• Not pregnant or nursing
• No untreated ocular inflammation or infection
• No medical or psychiatric condition that would preclude study compliance, ability to give informed consent, or assessment of response or anticipated toxic effects
• No 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
• No contraindication to intramuscular injections

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 3 weeks since prior trastuzumab (Herceptin®)
• No concurrent trastuzumab

Chemotherapy

• More than 3 weeks since prior chemotherapy
• No more than 2 prior chemotherapy regimens for metastatic disease
• No concurrent chemotherapy

Endocrine therapy

• More than 3 months since prior luteinizing hormone-releasing hormone agonists or antagonists (patients 55 years old and under)
• No prior hormonal therapy for metastatic disease
• No prior estrogen receptor down-regulators (e.g., fulvestrant) in the adjuvant setting
• No prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, or aminoglutethimide) in the adjuvant setting
• No other concurrent hormonal therapy

Radiotherapy

• 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

Surgery

• Not specified

Other

• No prior agents that target epidermal growth factor receptors
• No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, or verapamil)
• No concurrent anticoagulants, except for thrombotic events in patients in arm I
• No 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)
• Concurrent bisphosphonates for hypercalcemia or bone metastases are allowed