2024-518811-20-00尚未招募2 期
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment with Inavolisib Combinations in Patients with Untreated, Early-Stage, PIK3CA-Mutated Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 14
- 主要终点
- Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading scale
研究概览
简要总结
To evaluate the safety and tolerability of inavolisib-based treatment combination(s)
研究设计
- 分配方式
- Randomized
- 主要目的
- Open-label, Multicenter Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
- •Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- •Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- •Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, assessed locally and defined as ≥ 1% of tumor cells stained positive for ER
- •Documented HER2-negative tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, assessed locally
- •Documented Ki-67 score ≥ 5% as per local assessment
- •Confirmed PIK3CA mutation, as documented through central laboratory testing of a representative formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample
排除标准
- •Stage IV (metastatic) breast cancer
- •Inflammatory breast cancer (cT4d)
- •Bilateral invasive breast cancer
- •History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
- •Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
- •Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
结局指标
主要结局
Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading scale
Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading scale
Change from baseline in selected clinical laboratory test results
Change from baseline in selected clinical laboratory test results
Tolerability, as assessed by the overall treatment exposure and the incidence of dose modifications
Tolerability, as assessed by the overall treatment exposure and the incidence of dose modifications
次要结局
- Pathologic Complete Response (pCR) rate in breast and axilla (ypT0/Tis ypN0) according to local pathologist assessment following the American Joint Committee on Cancer (AJCC) TNM staging system (Amin et al. 2017; NCCN 2024)
- Tumor overall objective response rate (ORR)
- Changes in Ki-67 by immunohistochemistry (IHC)
- Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed through use of the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
- Proportion of participants reporting each response option at each assessment timepoint for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General (FACT-G)
- Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of PRO-CTCAE and the FACT-G GP5 item
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (14)
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