Abstract OT3-3-10: ASTER 70s: Benefit of adjuvant chemotherapy for oestrogen receptor-positive HER2-negative breast carcinoma in women over 70 according to Genomic Grade. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) multicentre phase III trial.
Authors: Brain E , Baffert S , Bonnefoi HR , Cottu P , Girre V , Lacroix-Triki M , Latouche A , Leger-Falandry C , Peyro Saint Paul HP , Rollot F , Romieux G , Servent V , Orsini C , Bonnetain F 
Published: August 2014

Abstract
Background: Despite a high incidence of oestrogen receptor-positive (ER+) HER2-negative (HER2−) breast carcinoma (BC) in elderly women, rationale and modalities of adjuvant chemotherapy (CT) vary greatly and remain heterogeneous after 70 years, precluding evaluation of its benefit and impact on functional status and outcome. As for trials investigating innovative treatments, elderly patients are often excluded from programs evaluating new modern prognosis classifiers.
Trial design: ASTER 70s is a prospective multicentre trial that investigates the impact on overall survival (OS) of adjuvant CT in elderly ER+ HER2− BC patients selected with a modern prognosis classifier while taking into account competing risks for mortality (EudraCT 2011–004744-22). After surgery, 2,000 patients over 70 years will have genomic grade (GG) assessed centrally by qRT-PCR on formalin-fixed paraffin-embedded samples (Ipsogen). Only those with a high GG or Equivocal (estimation∼700, group I) will be randomized between endocrine treatment alone and CT followed by endocrine treatment. CT regimen is left to the choice of investigators amongst 3 regimen of same duration [4 q3w cycles, docetaxel+cyclophosphamide (TC), doxorubicin or non pegylated liposomal doxorubicin (Myocet®)+cyclophosphamide (AC or MC), all with G-CSF], as well as endocrine treatment (aromatase inhibitor±tamoxifen). Radiotherapy will follow standard guidelines. Patients with low GG or not randomized for any reason (estimation∼1,300, group II) will be followed up as an observational cohort, with endocrine treatment only.
Eligibility criteria: Any ER+ HER2− BC after complete surgery, M0, any pT or pN. Normal organ functions. No specific BC treatment before surgery. No exclusion for underlying medical condition unless potential contra-indication to study drugs.
Specific aims: OS is the primary endpoint. Secondary endpoints address competing risks for mortality, include cost-effectiveness and QTWiST analysis, geriatric questions, acceptability and quality of life (QLQ C30 and specific elderly scale ELD15). The Lee's 4-year mortality score is calculated. The G8 screening tool is also assessed and used for stratification. Translational research will focus on ageing and prognostic biomarkers, and pharmacogenetic.
Statistical methods: Sample size based on 4-year OS (87.5 vs 80%), bilateral test, α=0.05, β=0.20 and HR= 0.60.
Present accrual and target accrual: The trial has been opened to inclusion in April 2012. 14 centres have been activated with 14 patients included: 7 randomized in group I, 2 included in the cohort (group II) and 4 with GG determination ongoing.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT3-3-10.