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 MaiaPublished 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.
Keyphrases
- phase ii
- clinical trial
- phase iii
- open label
- locally advanced
- rectal cancer
- lymph node
- study protocol
- randomized controlled trial
- neoadjuvant chemotherapy
- double blind
- oxidative stress
- placebo controlled
- squamous cell carcinoma
- medical education
- radiation therapy
- gestational age
- replacement therapy
- contrast enhanced ultrasound
- smoking cessation
- oxide nanoparticles