EUCTR2013-000568-28-BE进行中（未招募）1 期
A phase II randomized, double-blind study of neoadjuvant letrozole plus GDC-0032 versus letrozole plus placebo in postmenopausal women with ER-positive/HER2-negative, early stage breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
- •– Primary tumor = 2 cm in largest diameter (cT1-3) by MRI. In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be = 2 cm and designated as the target” lesion for all subsequent tumor evaluations.
- •– Stage I to operable Stage III breast cancer
- •– Documentation confirming the absence of distant metastasis (M0) as
- •determined by institutional practice (in patients where there may be a
- •reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms).
- •ER-positive and HER2-negative breast cancer, as per local laboratory or regional definition
- •Breast cancer eligible for primary surgery
- •Tumor tissue from FFPE core biopsy of breast primary tumor that is confirmed as evaluable for PIK3CA mutation status by central histopathology laboratory
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Fasting glucose =125 mg/dL
- •Adequate hematological, renal, and hepatic function, as follows:
- •– Absolute neutrophil count = 1500/µL
- •– Platelets count =100,000/µL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 198
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •Any prior treatment for primary invasive breast cancer
- •Patients with cT4 or cN3 stage breast tumors
- •Metastatic (Stage IV) breast cancer
- •Bilateral invasive breast cancer
- •Multicentric breast cancer (the presence of more than one tumor in different quadrants of the breast)
- •Patients who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes
- •Patients who have undergone sentinel lymph node biopsy prior to study treatment
- •Patients for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment
- •Patients for whom immediate surgery is indicated
- •Type 1 or 2 diabetes requiring antihyperglycemic medication
- •Inability or unwillingness to swallow pills
- •Malabsorption syndrome or other condition that would interfere with enteric absorption
研究者
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