Activity of exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors: a phase II trial.
PE Lønning, E Bajetta, R Murray, M Tubiana-Hulin, PD Eisenberg, E Mickiewicz, L Celio, P Pitt, M Mita, NK Aaronson, C Fowst, A Arkhipov, E di Salle, A Polli, G Massimini
Journal of Clinical Oncology | Published : 2000
PURPOSE: To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator, exemestane, in postmenopausal women with metastatic breast cancer who had progressive disease (PD) after treatment with a nonsteroidal aromatase inhibitor. PATIENTS AND METHODS: In this phase II trial, eligible patients were treated with exemestane 25 mg daily (n = 241) followed, at the time PD was determined, by exemestane 100 mg daily (n = 58). RESULTS: On the basis of the intent-to-treat analysis by independent review, exemestane 25 mg produced objective responses in 6.6% of patients (95% confidence interval [CI], 3.8% to 10.6%) and overall success (complete response + partial response + no ..View full abstract