NCT03575065已完成2 期
An Open Label, Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
BeiGene20 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年6月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 20
- 主要终点
- Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)
研究概览
简要总结
This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
- •Locally advanced or metastatic breast cancer despite standard therapy and the following:
- •Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
- •≤ 2 prior lines of chemotherapy in advanced or metastatic setting
- •Prior platinum therapy allowed as long as no disease progression while on treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last platinum to relapse
- •Prior therapy with an anthracycline and/or a taxane in neoadjuvant/adjuvant or metastatic setting
- •Archival tumor tissues will be collected from all patients, if available
- •For HR(+)/HER2(-) breast cancer only: patients must have received and progressed on at least one endocrine therapy either in adjuvant or metastatic setting, or have disease that the treating physician believes to be inappropriate for endocrine therapy
- •Measurable disease as defined per RECIST, version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Adequate hematologic and organ function
排除标准
- •Unresolved acute effects of prior therapy of ≥ Grade 2
- •Prior treatment with a poly[ADP-ribose] polymerase (PARP) inhibitor
- •Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1
- •Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
- •Diagnosis of myelodysplastic syndrome (MDS)
- •Other diagnosis of malignancy
- •Untreated and/or active brain metastases.
- •Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
- •Clinically significant cardiovascular disease
- •Pregnancy or nursing
- •Known history of intolerance to the excipients of the BGB-290 capsule
研究组 & 干预措施
Cohort 1: Triple-negative breast cancer (TNBC)
Experimental
Locally advanced or metastatic TNBC
干预措施: BGB-290 (Drug)
Cohort 2: HR(+)/HER2(-) breast cancer
Experimental
Locally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
干预措施: BGB-290 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)
时间窗: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)
ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
次要结局
- Progression-free Survival (PFS) as Assessed by IRC and Investigator(From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months))
- Duration of Response (DOR) as Assessed by IRC(From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months))
- Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator(Approximately 2 years and 10 months)
- Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator(From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months))
- Overall Survival (OS)(From the first dose of pamiparib until death (approximately 2 years and 10 months))
- Duration of Response (DOR) as Assessed by the Investigator(From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months))
- Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)(Up to approximately 2 years and 10 months)
- ORR as Assessed by Investigator(From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months))
- Disease Control Rate (DCR) as Assessed by IRC and Investigator(From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months).)
研究者
研究点 (20)
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