2024-516196-32-00招募中3 期
Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) - an international randomized phase III trial
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting10 个研究点 分布在 2 个国家目标入组 172 人开始时间: 2025年1月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 10
- 主要终点
- Overall survival, defined as the time from randomization to death from any cause in all patients.
研究概览
简要总结
To investigate whether neoadjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mCTC) (and adjuvant capecitabine for patients without (near) pathologic complete response) compared to AC-CP chemotherapy (and adjuvant capecitabine for patients without (near) pathologic complete response) followed by 1-year olaparib monotherapy substantially improves overall survival (OS) in patients with stage III, HER2-negative, HR impaired or HR deficient breast cancer.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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
- •Males or females ≥18 and <66 years of age and fit to undergo autologous stem cell transplantation
- •Histologically confirmed adenocarcinoma of the breast
- •The tumor must be: HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 at immunohistochemistry);AND Hormone receptor negative; or in case of a histological grade III tumor an estrogen receptor of <50% and progesterone receptor of <50% (Unless BRCA1 or BRCA2 germline mutation carrier)
- •Patients treated in the neoadjuvant setting
- •Women and men with stage III adenocarcinoma of the breast (according to AJCC staging manual 7th edition; Stage IIIA: T0-2N2 or T3N1-2; Stage IIIB: T4N0-2; Stage IIIC: any TN3) harboring signs of a breast cancer with features of homologous recombination deficiency (HRD) Based on the results of the preliminary work, the following HRD working definition will be employed: The patient is a known BRCA1 or BRCA2 mutation carrier; and/or the tumor exhibits a BRCA1 promoter hypermethylation, and/or the tumor exhibits a BRCA1-like DNA copy number profile
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Provision of informed consent
排除标准
- •Evidence of distant metastases
- •Previous radiation therapy
- •Previous chemotherapy (except for ddAC cycles 1-3 for the current breast cancer, or another third generation chemotherapy cycle 1
- •Any previous treatment with a PARP-inhibitor, including olaparib
- •Pre-existing neuropathy from any cause > Grade 1
- •Pregnant; or breastfeeding and not willing to stop breastfeeding in order to be able to participate in the study
结局指标
主要结局
Overall survival, defined as the time from randomization to death from any cause in all patients.
Overall survival, defined as the time from randomization to death from any cause in all patients.
次要结局
- Key secondary endpoint: Overall survival, defined as the time from randomization to death from any cause in patients without a germline BRCA1/2 mutation.
- Recurrence-free interval, defined as time from randomization to invasive ipsilateral breast tumor recurrence, locoregional- or distant recurrence, or death from breast cancer, whichever comes first, in all patients, regardless of germline BRCA1/2 status.
- Recurrence-free interval defined as time from randomization to invasive ipsilateral breast tumor recurrence, locoregional- or distant recurrence, or death from breast cancer, whichever comes first, in patients with an HR impaired tumor (i.e. harboring a BRCA1-like copy number profile or BRCA1 promotor hypermethylation, in the absence of a known germline BRCA1/2 mutation).
- (non-)hematological toxicity determined according to CTCAE v4.03.
- cost-effectiveness measured by costs per quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER).
- Patient reported outcomes; including an interview, quality of life (QoL) determined by a comprehensive panel of QoL questionnaires and cognitive function
- Several potential biomarkers
- The difference in overall survival between patients treated in the SUBITO trial and patients with the same characteristics treated outside of the trial in the Netherlands (using data from the Netherlands Cancer Registry (NCR)).
研究者
Prof. Dr. S.C. Linn
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (10)
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