NL-OMON54330招募中2 期
SEQUence of Endocrine therapy in advanced Luminal Breast cancer (SEQUEL-Breast) A phase 2 study on fulvestrant beyond progression in combination with alpelisib for PIK3CA-mutated, hormone-receptor positive HER2 negative advanced breast cancer. - SEQUEL-Breast trial
BOOG Study Center0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Adult women and men (>= 18 years of age) with proven diagnosis of
- •adenocarcino-ma of the breast with locoregional recurrent or metastatic disease
- •not amenable to resection or radiation therapy with curative intent and for
- •whom chemotherapy is not clinically indicated
- •* Estrogen receptor (ER) expression >10% and/or progesterone receptor (PR)
- •expression >10% breast cancer based on local la-boratory results. Tumor must be
- •HER2- as defined by ASCO-CAP guidelines
- •* Patients must have progressed on fulvestrant as a preceding treatment line
- •(as first or second line therapy)
- •* Previous treatment with a CDK4/6 inhibitor in the advanced setting
- •* The presence of an activating PIK3CA mutation
- •* Evaluable disease* as defined per RECIST v.1.1
- •* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
排除标准
- •* Patients with advanced, symptomatic, visceral spread, who are at risk of
- •life-threatening complications in the short term
- •* Known active uncontrolled or symptomatic CNS metastases, carcinomatous
- •meningitis, or leptomeningeal disease as indicated by clinical symptoms,
- •cerebral edema, and/or progressive growth
- •* Prior treatment with an PI3K /AKT/mTOR inhibitor
- •* Prior treatment with chemotherapy in the advanced setting
- •* (prior) use of oral SERD in any setting
- •* Type 1 diabetes or uncontrolled type 2 diabetes (Hba1C > 68 mmol/mol)
- •* Clinically significant, uncontrolled heart disease and/or recent cardiac
研究者
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