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• W3026259685 abstract "In pts with HR+ EBC who are candidates to receive adjuvant CT, endocrine therapy (ET) is currently administered following CT completion. This recommendation is based on preclinical and clinical data suggesting a potential negative interaction between tamoxifen and CT when given concomitantly. However, there is no evidence to support this recommendation with the use of modern CT regimens containing taxanes or when AIs are given as adjuvant ET. Therefore, the optimal timing for integrating modern adjuvant CT and ET with AIs has not been defined yet. GIM 10 – CONSENT is an ongoing prospective, two-arm randomized, multicenter, open-label, phase III trial in postmenopausal pts with surgically removed HR+ EBC who are candidates to adjuvant CT. Pts with HER2+ BC are eligible only if scheduled to receive adjuvant trastuzumab. Pts are randomized 1:1 to receive ET with an AI following completion of CT (sequential arm) or concurrently with CT (concurrent arm). The choice of CT regimen is at physician discretion; anastrozole, letrozole or exemestane are given for at least 5 years. Primary study endpoint is disease-free survival (DFS). Invasive DFS, distant DFS, distant relapse-free survival, overall survival and toxicity are secondary endpoints. Tumor collection is performed in pts defined at clinical intermediate risk (stage I-II HR+ G2) for future translational studies aiming to analyze their genomic, epigenetic and proteomic landscape. After final amendment, study hypothesis is that concurrent administration of CT and ET will be associated with a 25% relative reduction in the hazard of recurrence, with a 9.4% absolute increase in 10-year DFS. For a type I error level of .05 (two sided) and 80% power, 500 pts per arm are required to observe 350 events presumably after 5.5 years of follow-up. The study is ongoing at 55 GIM centers. Accrual was completed in June 2019 with 1,014 randomized pts; follow-up is currently ongoing. 2013-001629-23; NCT02918084. IRRCS Ospedale Policlinico San Martino." @default.
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• W3026259685 date "2020-05-01" @default.
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• W3026259685 title "95TiP Gruppo Italiano Mammella (GIM) 10 – CONSENT: A phase III randomized study comparing concurrent versus sequential administration of adjuvant chemotherapy (CT) and aromatase inhibitors (AIs) in post-menopausal patients (pts) with hormone receptor-positive (HR+) early breast cancer (EBC)" @default.
• W3026259685 doi "https://doi.org/10.1016/j.annonc.2020.03.214" @default.
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