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Everolimus in combination with exemestane in the treatment of postmenopausal women with estrogen receptor-positive metastatic breast cancer who are refractory to letrozole or anastrozole: Preliminary results of the BOLERO-2 trial.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: The PI3K/Akt/mTOR pathway, a key regulator of cellular proliferation, cellular metabolism, and angiogenesis, is constitutively activated in aromatase inhibitor–resistant breast cancer. Everolimus (EVE), an inhibitor of the PI3K/Akt/mTOR pathway, has single-agent activity and provides additional efficacy to long-term estrogen deprivation when combined with letrozole in the neoadjuvant setting. Combination of EVE and exemestane may improve outcomes for patients ER+ breast cancer refractory to nonsteroidal aromatase inhibitors (NSAI). Methods: In this multinational, double-blind, placebo-controlled phase III study, postmenopausal women ≥18 years old with ER+ locally advanced or metastatic breast cancer whose disease was refractory to NSAI and documented recurrence or progression were stratified by sensitivity to prior hormonal therapy and the presence of visceral metastasis and then randomized (2:1) to EVE (10 mg daily) or matching placebo orally once daily, with both arms receiving exemestane (25 mg daily). Treatment was continued until disease progression or unacceptable toxicity. The primary outcome was progression-free survival (PFS) assessed by the investigators. Secondary outcomes included overall survival, overall response rate, time to deterioration of ECOG performance status, safety, and change in QoL scores over time. Between June 2009 and January 2011, 723 patients were randomized from 24 countries; 84% had hormone sensitive-disease and 56% had visceral disease. An interim analysis based on safety and efficacy reviewed by the independent data monitoring committee will be performed when 317 PFS events have occurred. The IDMC meeting is planned for May 2011.
Abstracts by J. Baselga:
A multicenter, open-label phase II trial of dovitinib, a fibroblast growth factor receptor 1 (FGFR1) inhibitor, in FGFR1-amplified and nonamplified metastatic breast cancer (BC).Meeting: 2011 Breast Cancer Symposium | Abstract No: 289
A dose-escalation study with the novel formulation of the oral pan-class I PI3K inhibitor BEZ235, solid dispersion system (SDS) sachet, in patients with advanced solid tumors.Meeting: 2011 ASCO Annual Meeting | Abstract No: 3066
A multicenter, open-label phase II trial of dovitinib, an FGFR1 inhibitor, in FGFR1 amplified and non-amplified metastatic breast cancer.Meeting: 2011 ASCO Annual Meeting | Abstract No: 508Category: Breast Cancer - HER2/ER - ER+