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A Research Protocol for a Phase II Single-Arm Clinical Trial Assessing the Feasibility and Efficacy of Neoadjuvant Anastrozole in Patients With Luminal Breast Cancer and Low Proliferative Index: The ANNE Trial.

Carlos Eduardo PaivaAlinne Tatiane Faria SilvaIzabella da Silva OliveiraVitor Souza GuimarãesDomício Carvalho LacerdaGustavo Ramos TeixeiraAnapaula Hidemi Uema WatanabeNilton OnariBianca Sakamoto Ribeiro PaivaIdam de Oliveira-JuniorMarcia Maria Chiquitelli MarquesYara Cristina de Paiva Maia
Published in: Cancer control : journal of the Moffitt Cancer Center (2024)
Postmenopausal women with luminal, HER2-tumors in stages II and III undergo neoadjuvant anastrozole treatment, evaluating continuing NET or receiving chemotherapy through early Ki67 analysis after 2 to 4 weeks. The study assesses NET extension for up to 10 months, using serial follow-ups with standardized breast ultrasound and clinical criteria-based NET suspension. Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.
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