GERICO11_Adjuvant systemic treatment for oestrogen-receptor (ER)-positive HER2-negative breast carcinoma in women over 70 according to Genomic Grade (GG): chemotherapy + endocrine treatment versus endocrine treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) multicentre phase III trial

oestrogen-receptor (ER)-positive HER2-negative breast carcinoma

Overall Survival (OS) with 4 years of follow-up (ie median follow-up = 4 years)

Breast cancer-specific survival (BCSS), Invasive disease-free survival (iDFS), Event-free survival (EFS), Relapse-free survival (RFS), Evaluation of Toxicity, Quality of life: Quality of life (QoL) will be assessed using the national version of EORTC QLQ-C30 (version 3) and QLQ-ELD15, a QLQ C30 supplement module for the assessment of quality of life in the elderly patient with cancer, Q-TWiST analysis, Geriatric assessment, Treatment acceptability, Predictive value of a 4-year mortality score, Usefulness of GG by RT-PCR as a prognostic signature and performance in an elderly population by comparison to standardized routine histopathological criteria and to the results obtained in the general non elderly population, Cost-effectiveness analysis, Follow-up of a cohort of elderly BC patients not treated with adjuvant chemotherapy (including non eligibility due to GG)., Ancillary study criterai (Only applicable for France): The prognostic value of HalioDx GG testing on iDFS and D-DFS/D-RFS will be assessed in the first 500 patients in the screened population (cohort group and randomized group [in both arms]) with a follow-up of 36 months.

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Belgium, France