Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial,The Lancet Oncology

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Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial
The Lancet Oncology ( IF 41.6 ) Pub Date : 2024-08-27 , DOI: 10.1016/s1470-2045(24)00373-5
Mafalda Oliveira ₁ , Hope S Rugo ₂ , Sacha J Howell ₃ , Florence Dalenc ₄ , Javier Cortes ₅ , Henry L Gomez ₆ , Xichun Hu ₇ , Masakazu Toi ₈ , Komal Jhaveri ₉ , Petr Krivorotko ₁₀ , Sibylle Loibl ₁₁ , Serafin Morales Murillo ₁₂ , Meena Okera ₁₃ , Zbigniew Nowecki ₁₄ , Yeon Hee Park ₁₅ , Joo Hyuk Sohn ₁₆ , Eriko Tokunaga ₁₇ , Samih Yousef ₁₈ , Lyudmila Zhukova ₁₉ , Marta Fulford ₂₀ , Haylee Andrews ₂₁ , Ian Wadsworth ₂₂ , Celina D'Cruz ₂₃ , Nicholas C Turner ₂₄ ,

Affiliation

Medical Oncology Department, Vall d'Hebron University Hospital, and Breast Cancer Unit, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
The Christie NHS Foundation Trust, Manchester, UK.
Oncopole Claudius Regaud, Institut Universitaire du Cancer-Toulouse, Toulouse, France.
Oncology Department, International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain; Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain.
Departamento de Oncología Médica, Instituto Nacional de Enfermedades Neoplásicas (INEN) and Universidad Ricardo Palma, Lima, Peru.
Shanghai Cancer Center, Fudan University, Shanghai, China.
Kyoto University Hospital, Kyoto, Japan.
Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Petrov Research Institute of Oncology, St Petersburg, Russia.
GBG Forschungs GmbH, Neu-Isenburg and Centre for Haematology and Oncology, Frankfurt, Germany.
Institut de Recerca Biomèdica, Barcelona, Spain.
Icon Cancer Centre, Adelaide, SA, Australia.
Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.
Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, South Korea.
NHO Kyushu Cancer Center, Fukuoka, Japan.
Emek Medical Center, Afula, Israel.
Loginov Moscow Clinical Scientific Center, Moscow, Russia.
Oncology R&D, AstraZeneca, Warsaw, Poland.
Oncology R&D, AstraZeneca, Gaithersburg, MD, USA.
Oncology R&D, AstraZeneca, Cambridge, UK; PHASTAR, London, UK.
Oncology R&D, AstraZeneca, Waltham, MA, USA.
Royal Marsden Hospital, Institute of Cancer Research, London, UK.

CAPItello-291 is an ongoing phase 3 trial in which capivasertib–fulvestrant significantly improved progression-free survival versus placebo–fulvestrant in patients with hormone receptor-positive, HER2-negative advanced breast cancer who had relapse or disease progression during or after aromatase inhibitor treatment, in both the overall population and in patients with PIK3CA, AKT1, or PTEN-altered tumours. This study further explored patient-reported health-related quality of life (HRQOL), functioning, symptoms, and symptom tolerability in CAPItello-291.

中文翻译：

Capivasertib 和氟维司群治疗激素受体阳性、HER2 阴性晚期乳腺癌患者（CAPItello-291）：一项 3 期、随机、双盲、安慰剂对照试验的患者报告结局

CAPItello-291 是一项正在进行的 3 期试验，其中 capivasertib-氟维司群与安慰剂-氟维司群相比，在芳香化酶抑制剂治疗期间或之后出现复发或疾病进展的激素受体阳性、HER2 阴性晚期乳腺癌患者中，在总人群和 PIK3CA、AKT1 或 PTEN 突变肿瘤患者中。本研究进一步探讨了 CAPItello-291 中患者报告的健康相关生活质量（HRQOL）、功能、症状和症状耐受性。

更新日期：2024-08-27

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