| Exclusion Criteria: | Previously irradiated tumor constitutes the only site of disease.
Any unresolved chronic toxicity greater than CTC grade 2 from previous anti-cancer therapy.
Patients having any other acute or chronic medical or psychiatric condition or a laboratory abnormality that may increase the risks associated with study participation or may interfere with the interpretation or compliance with the study.
Rapidly progressive visceral metastasis and liver metastatic disease with greater than one-third involvement of the liver, or significant symptomatic pulmonary metastasis or lymphangitis.
Patients with central nervous system (CNS) metastasis are not eligible.
Patients are not eligible if they have any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
Concurrent cancer with the exception of adequately treated carcinoma in situ of the cervix, contralateral breast cancer, non-melanoma skin cancer, and any cancer that has been in remission for 5 years or more.
Prior treatment with an aromatase inhibitor.
Prior treatment with a tyrosine kinase inhibitor regardless of the targeted receptor.
Known hypersensitivity to anastrozole or any of the excipients of this product.
Known hypersensitivity to ZD1839 or any excipients of this product.
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort (refer to section 3.4.4, for full list of excluded medications).
Treatment with luteinizing hormone-releasing hormone (LH-RH) analog.
Concomitant hormone replacement therapy (HRT).
Previous exposure to chemotherapy for MBC.
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