NCT04556292Unknown2 期
A Phase 2, Open-Label, Multi-Center Study of SC10914 in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received More Than 2 Prior Chemotherapy Regimens for Metastatic Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This open label, multi-centre phase II study will assess the efficacy and safety of single agent SC10914 in metastatic breast cancer patients with gBRCA 1/2 mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Germline mutation in BRCA1 or BRCA2
- •Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
- •Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting
- •Patients who have received platinum (cisplatin or carboplatin, either as monotherapy or in combination) for advanced breast cancer are eligible to enter the study provided platinum-free interval at least 6 months (time from last dose of platinum chemotherapy to disease progression
- •Patients who have received platinum as potentially curative treatment for a prior cancer (e.g. ovarian cancer) or as adjuvant/neoadjuvant treatment for breast cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and eligible .
- •Patients with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy .
- •At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.
- •ECOG performance status 0-
- •Adequate bone marrow, kidney and liver function
排除标准
- •Prior treatment with PARP inhibitor.
- •Patients with HER2 positive disease
- •Untreated and/or uncontrolled brain metastases
- •Known HIV (Human Immunodeficiency Virus) infection.
- •Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia
- •Pregnant or breast feeding women
研究组 & 干预措施
SC10914 group
Experimental
干预措施: SC10914 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Assessed up to a maximum of 30 months
Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
次要结局
- Progression-free Survival (PFS)(Assessed up to a maximum of 30 months)
- Overall Survival (OS)(Assessed up to a maximum of 30 months)
研究者
研究点 (1)
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