Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer progressing on prior non-steroidal aromatase inhibitors:primary results of a phase IIIb, open-label, single-arm, expanded-access multicenter trial (BALLET)
- Jerusalem, G.
- Mariani, G.
- Ciruelos, E. M.
- Martin, M.
- Tjan-Heijnen, V. C. G.
- Neven, P.
- Gavila, J. G.
- Michelotti, A.
- Montemurro, F.
- Generali, D.
- Simoncini, E.
- Lang, I.
- Mardiak, J.
- Naume, B.
- Camozzi, M.
- Lorizzo, K.
- Bianchetti, S.
- Conte, P.
DOIAbstract
Background: This European phase IIIb, expanded-access multicenter trial evaluated the safety of EVE plus EXE in a patient populationsimilartoBOLERO-2. Patients and methods: Post-menopausal women aged ≥18 years with hormone receptor-positive, human epidermal growth factor-receptor-2–negative advanced breast cancer (ABC) recurring/progressing during/after prior non-steroidal aromatase inhibitors were enrolled. The primary objective was safety of EVE plus EXE based on frequency of adverse events(AEs),andserious AEs(SAEs).The secondaryobjectivewastoevaluateAEs ofgrade3/4 severity. Results: The median treatment duration was 5.1 months [95% confidence interval (CI) 4.8–5.6] for EVE and 5.3 months (95% CI 4.8–5.6) for EXE. Overall, 2131 patients we...
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