PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers (PALB2-PARPi-01)
2022年2月21日 更新者：Assistance Publique - Hôpitaux de Paris
Phase II Clinical Trial Aiming at Investigating the Effect of a PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers.
This study is designed as a multicentre one-arm two-stage phase 2 clinical trial
研究概览
研究类型
介入性
注册 (预期的)
12
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Odile Cohen Haguenauer, MD PhD
- 电话号码：+ 33 1 42 49 47 98
- 邮箱：odile.cohen-haguenauer@aphp.fr
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult patients over 18 years
- PALB2 germline heterozygous mutation carrier, wild type BRCA1&2 (breast cancer 1&2) affected with metastatic breast cancer in first metastatic treatment line or beyond
- Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
- Triple Negative breast cancer; Patients affected with triple negative cancers should have received anthracyclines and taxanes in neo/adjuvant therapy.
- Or patients with Hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) breast cancer, with treatment failure after a second line of therapy; Estrogen Receptor/ProgesteroneReceptor breast cancer positive patients must have received and progressed on currently recommended therapies in this indication (endocrine therapy, CDK4/6 inhibitors (adjuvant or metastatic)), or have a disease form that the treating physician believes to be inappropriate for recommended therapies in this indication.
- Prior therapy with an anthracycline and a taxane in an adjuvant setting.
- Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow, kidney and liver function.
- Patients without visceral crisis
Exclusion Criteria:
- Patients with HER2 positive disease.
- Untreated and/or uncontrolled brain metastases.
- Patients in visceral crisis requiring chemotherapy
- Cytopenia, defined with the following thresholds: (i) Neutrophil count < 1500/mm3; Platelet count< 100 000/mm3; Hemoglobin <9g/dL
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS) or stage I grade 1 endometrial cancer allowed.
- Known HIV (Human Immunodeficiency Virus) infection.
- Pregnant or breast-feeding women.
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Niraparib
PARP-inhibitor, Niraparib Dosage : starting 300 mg/day for patients with body weight ≥77kg and platelet counts ≥ 150 000/µl or 200 mg when body weight inferior to 77kg and/or platelet counts ≤ 150 000/µl and > 100 000/µl Pharmaceutical form : 100 mg capsules Posology : single dose daily Route of administration : oral Administration procedures : oral, daily single dose Duration of treatment : 12 cycles of 28 days each
|
Niraparib, once daily
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate
大体时间：4 months
|
Complete or partial tumour response according to RECIST 1.1 criteria accounting for objective response rate in solid tumours at 4 cycles., based on the CT-Scan
|
4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival
大体时间：12 months
|
Time from inclusion to progression or death (all-cause) or last follow-up whichever occurs first
|
12 months
|
|
Overall survival
大体时间：12 months
|
Time from inclusion to death (all-cause) or last follow-up whichever occurs first
|
12 months
|
|
Tumoral response
大体时间：12 months
|
Partial Response or Complete Response or Stable Disease, as per to RECIST 1.1 criteria for tumoral response, based on CT-Scan
|
12 months
|
|
Duration of response
大体时间：12 months
|
Time to treatment failure, defined as time between inclusion and treatment discontinuation (any reason: death, disease progression, toxicity) or last follow-up
|
12 months
|
|
Adverse event rate
大体时间：72 months
|
Adverse events (clinical and biological) between inclusion and 72 months
|
72 months
|
|
Quality of Life variation
大体时间：12 months
|
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire, evaluated every 3 months, from inclusion to 12 month
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年5月1日
初级完成 (预期的)
2024年9月1日
研究完成 (预期的)
2030年5月1日
研究注册日期
首次提交
2022年1月28日
首先提交符合 QC 标准的
2022年1月28日
首次发布 (实际的)
2022年2月9日
研究记录更新
最后更新发布 (实际的)
2022年3月8日
上次提交的符合 QC 标准的更新
2022年2月21日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.