Randomized 3-arm, phase 2 study of temsirolimus (CCI-779) in combination with letrozole in postmenopausal women with locally advanced or metastatic breast cancer
- 1 June 2005
- journal article
- breast cancer
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 23 (16_suppl) , 564
- https://doi.org/10.1200/jco.2005.23.16_suppl.564
Abstract
564 Background: Temsirolimus (tem, CCI-779), a novel mTOR inhibitor, is well tolerated and has antitumor activity in heavily pretreated patients (pts) with metastatic breast cancer (MBC, Proc ASCO 22:193,2003). In this trial, we evaluate safety and activity of oral tem in combination with letrozole. Methods: Patients with measurable MBC were randomized in a 1:1:1 ratio (∼30 evaluable pts/arm): 1) letrozole alone or letrozole with 2) tem daily (tem daily arm) or 3) tem daily for 5 days every 2 weeks (tem intermittent arm). All pts received 2.5 mg letrozole daily. Results: Initially, tem doses were 25 mg daily and 75 mg intermittent but were amended to 10 mg daily and 30 mg intermittent because 10 of 12 pts had dose delays, reductions, or discontinuations. Data collected by 15 Nov 2004 are presented for the 92 pts enrolled after the amendment (tem daily: 33; tem intermittent: 30; letrozole alone: 29). Grade 1–4 toxicities, regardless of causality, that occurred in >30% of pts included 10 mg daily: asthenia ...Keywords
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