A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER - WO43571

F. Hoffmann-La Roche AG0 个研究点目标入组 812 人开始时间: 2022年2月24日最近更新: 2024年7月22日

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•Participants (females, regardless of menopausal status, and males) who are aged >=18 years at the time of signing Informed Consent Form, Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection, At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Disease-free interval from completion of adjuvant or neoadjuvant systemic nonhormonal treatment to recurrence of >=6 months, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, Left ventricular ejection fraction (LVEF) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)

•Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting, Previous treatment with approved or investigative anti- human epidermal growth factor receptor 2 (HER2) agents, Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better, Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy, History of persistent Grade >=2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy, For pre- and perimenopausal women, and men: 1) Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa) 2) Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy (ET) that requires gonadal function suppression, Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B, Refrain from consumption of grapefruit or grapefruit juice, grapefruit supplements, or Seville oranges (potent CYP3A enzyme inhibitors) for at least 3 days prior to initiation of giredestrant in Arm B and throughout the maintenance phase

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