NCT01220570已完成1 期
A Clinical Trial to Qualify the Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- The population mean change from baseline in GFS (Growth Factor Signature) score
研究概览
简要总结
This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score among participants with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has operable Stage I-IIIa invasive breast cancer of the following subtype: ER-positive, HER2-negative tumor with histologic grade 2 or 3 and Ki67 ≥ 15%
- •Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
- •Participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
- •Participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
- •Participant must have adequate organ function
排除标准
- •Participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
- •Participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
- •Participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
- •Participant is unable to swallow capsules and/or absorb oral medications
- •Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
- •Participant is known to be Human Immunodeficiency Virus (HIV)-positive
- •Participant has known history of active Hepatitis B or C.
- •Participant is concurrently using growth hormone (GH) or growth hormone inhibitors
- •Participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months
研究组 & 干预措施
Ridaforolimus + Dalotuzumab
Experimental
Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646)
干预措施: Ridaforolimus + Dalotuzumab (Drug)
Ridaforolimus
Experimental
Ridaforolimus (MK-8669)
干预措施: Ridaforolimus (Drug)
Dalotuzumab
Experimental
Dalotuzumab (MK-0646)
干预措施: Dalotuzumab (Drug)
结局指标
主要结局
The population mean change from baseline in GFS (Growth Factor Signature) score
时间窗: Baseline and Day 15
次要结局
- The correlation between change in Ki67 expression and change in GFS after two weeks of treatment with ridaforolimus/dalotuzumab (MK-8669/MK-0646) combination therapy, ridaforolimus (MK-8669) monotherapy and/or dalotuzumab (MK-0646) monotherapy(Baseline and Day 15)
- The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy(Baseline and Day 15)
研究者
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