Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

  • Radiologically or clinically evident metastatic or locally recurrent disease
  • Locally advanced disease in elderly patients
  • Bone metastases only allowed
• Failed prior tamoxifen therapy
• No rapidly progressive visceral metastases
• No uncontrolled CNS metastases

• Hormone receptor status:

  • Estrogen receptor and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age

• Postmenopausal

Sex

• Female

Menopausal status

• Postmenopausal, defined by any of the following:

  • Natural menopause with last menses more than 1 year ago
  • Radiotherapy-induced oophorectomy with last menses more than 1 year ago
  • Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels clearly in the postmenopausal range
  • Surgical castration

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Transaminases no greater than 2.5 times ULN
• No unstable or uncompensated hepatic disease

Renal

• No unstable or uncompensated renal disease

Cardiovascular

• No unstable or uncompensated cardiac disease

Pulmonary

• No unstable or uncompensated pulmonary disease

• No clinically active interstitial lung disease

  • Asymptomatic chronic stable radiographic changes are allowed

Other

• No severe or uncontrolled systemic disease
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or contralateral breast cancer
• No psychological, familial, sociological or geographical condition that would preclude study compliance and follow-up
• No grade 2 or greater unresolved chronic toxicity from prior anticancer therapy
• No unresolved ocular inflammation or infection
• No known hypersensitivity to anastrozole or gefitinib or any of their excipients

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior trastuzumab (Herceptin)
• No concurrent biologic therapy

Chemotherapy

• No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting
• No concurrent chemotherapy

Endocrine therapy

• At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) in the adjuvant setting
• Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed
• No prior aromatase inhibitors for metastatic disease
• No other concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy to any metastatic site

Surgery

• No surgery during and within 4 days after the last dose of gefitinib

Other

• At least 30 days since prior investigational drugs
• No prior anti-epidermal growth factor therapy
• No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase inhibitor receptor)

• No concurrent administration of any of the following drugs:

  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Phenobarbital
  • Hypericum perforatum (St John's Wort)
• No other concurrent investigational drugs or treatment
• No other concurrent cancer treatment
• No concurrent systemic retinoids

• Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry

  • Bisphosphonates may be initiated during study only for the treatment of hypercalcemia