OBJECTIVE: This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer. METHODS: Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operationfor primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness. RESULTS: Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period. CONCLUSIONS: We hereby report the study concept.
RCT Entities:
OBJECTIVE: This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer. METHODS: Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness. RESULTS:Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period. CONCLUSIONS: We hereby report the study concept.
Authors: M Luque; F Arranz; J F Cueva; A de Juan; P García-Teijido; L Calvo; I Peláez; A García-Palomo; J García-Mata; S Antolín; L García-Estévez; Y Fernández Journal: Clin Transl Oncol Date: 2013-10-02 Impact factor: 3.405
Authors: Noam Pondé; Dominique Agbor-Tarh; Lissandra Dal Lago; Larissa A Korde; Florentine Hilbers; Christian Jackisch; Olena Werner; Richard D Gelber; Aminah Jatoi; Amylou C Dueck; Alvaro Moreno-Aspitia; Christos Sotiriou; Evandro de Azambuja; Martine Piccart Journal: Breast Cancer Res Treat Date: 2020-09-19 Impact factor: 4.872