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 3b, Open-Label, Single-Arm, Expanded-Access Multicenter Trial (BALLET)

Jerusalem, G; Mariani, G; Ciruelos, EM; Martin, M; Tjan-Heijnen, VCG; Neven, Patrick; Gavila, JG; Michelotti, A; Montemurro, F; Generali, D; Simoncini, E; Lang, I; Mardiak, J; Naume, B; Camozzi, M; Lorizzo, K; Bianchetti, S; Conte, P

doi:10.1093/annonc/mdw249

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 3b, Open-Label, Single-Arm, Expanded-Access Multicenter Trial (BALLET)

Author:

Jerusalem, G

Mariani, G ; Ciruelos, EM ; Martin, M ; Tjan-Heijnen, VCG ; Neven, Patrick ; Gavila, JG ; Michelotti, A ; Montemurro, F ; Generali, D ; Simoncini, E ; Lang, I ; Mardiak, J ; Naume, B ; Camozzi, M ; Lorizzo, K ; Bianchetti, S ; Conte, P

Keywords:

Science & Technology, Life Sciences & Biomedicine, Oncology, advanced breast cancer, BMI, elderly, everolimus, hormone-receptor positive, stomatitis, POSTMENOPAUSAL WOMEN, MTOR INHIBITION, BOLERO-2, SURVIVAL, THERAPY, TAMOXIFEN, EFFICACY, Aged, Aged, 80 and over, Androstadienes, Antineoplastic Combined Chemotherapy Protocols, Aromatase Inhibitors, Breast Neoplasms, Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions, ErbB Receptors, Everolimus, Female, Humans, Male, Neoplasm Metastasis, Neoplasm Recurrence, Local, Postmenopause, Receptor, ErbB-2, Receptors, Estrogen, Sirolimus, Receptor, erbB-2, 1112 Oncology and Carcinogenesis, Oncology & Carcinogenesis, 3202 Clinical sciences, 3211 Oncology and carcinogenesis

Abstract:

This European phase 3b, expanded-access multicenter trial evaluated the safety of EVE plus EXE in a patient population similar to BOLERO-2.