2022-500014-26-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 72
- 主要终点
- 1. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
研究概览
简要总结
To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo based on progression-free survival (PFS)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Long Term Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
1. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
1. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
次要结局
- 1. OS, defined as the time from randomization to death from any cause
- 2. ORR (following randomization), defined as the proportion of participants with a CR or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1
- 3. DOR (following randomization), defined as the time from the first occurrence of a documented objective response (complete response (CR) or partial response (PR) to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- 4. CBR (following randomization), defined as the proportion of participants with SD or non-CR/non-PD for ≥ 24 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1
- 5. Mean and mean changes from baseline score in function (role, physical) and health-related quality of life (HRQoL) by cycle and between treatment arms as assessed through the use of the Functional and GHS/QoL scales of the EORTC QLQ-C30
- 6. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
- 7. Change from baseline in targeted clinical laboratory test results
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (72)
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