2025-523013-28-00招募中2 期
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 29
- 主要终点
- Investigator-Assessed Confirmed ORR
研究概览
简要总结
To evaluate the efficacy of inavolisib plus ribociclib and fulvestrant compared with placebo plus ribociclib and fulvestrant with respect to investigator-assessed confirmed objective response rate (ORR)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
- •Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as ≥1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)
- •Patients must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen.
- •Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
排除标准
- •Metaplastic breast cancer (BC)
- •Radiotherapy within 2 weeks before randomization
- •Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., patients with visceral crisis)
- •Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- •Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible
- •Any history of leptomeningeal disease or carcinomatous meningitis
研究组 & 干预措施
FULVESTRANT
Test
干预措施: FULVESTRANT (Drug)
RIBOCICLIB, RIBOCICLIB
Test
干预措施: RIBOCICLIB (Drug)
Inavolisib placebo
Placebo
干预措施: Inavolisib placebo (Drug)
INAVOLISIB, INAVOLISIB
Test
干预措施: INAVOLISIB (Drug)
结局指标
主要结局
Investigator-Assessed Confirmed ORR
Investigator-Assessed Confirmed ORR
次要结局
- PFS
- OS
- Investigator-assessed DOR
- Investigator-assessed CBR
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- Change from baseline in targeted vital signs
- Change from baseline in targeted clinical laboratory test results
- Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities as assessed through use of the National Cancer Institute (NCI) Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument
- Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General questionnaire (FACT-G)
- Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of the PRO-CTCAE and FACT-G GP5 item, respectively
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (29)
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