Clinical Utility of a Next Generation Sequencing-based "Oncochip" for Therapeutic Decision in Metastatic Breast Cancer. Study SHARP
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Comparison of progression-free survival
研究概览
简要总结
The present trial clinical proposes to randomize patients with cancer metastatic disease of the breast progressing on standard therapy to receive a treatment selected from 4 "targeted" drugs (a MEK kinase inhibitor, an mTOR kinase inhibitor, an of the enzyme involved in DNA repair PARP and an androgen receptor inhibitor) on the basis of possible presence of mutations in a panel of 61 genes analyzed on metastatic tissue from biopsy, or receive standard chemotherapy.
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
- Single (Investigator)
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
- •Patients (women or men) with histologically confirmed metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Written informed consent obtained prior to enrollment
- •Age ≥ 18 years
- •Blood and tumor tissue sample available for research
- •Measurable disease
- •Other site accessible for biopsy, except bone lesions if this is the only accessible site, or biopsy obtained within the previous 6 months
- •Medical history, blood parameters and clinical conditions do not indicate major dysfunctions of organ
- •To treatment:
- •Maintenance of screening inclusion criteria
排除标准
- •Presence of visceral crisis, defined according to ABC3/ESMO guidelines
- •Patients with local recurrence that can be treated with surgery and/or radiotherapy alone
- •Patients who have previously received palliative radiotherapy on the only site accessible to biopsy
- •Patients with metastatic disease limited to bone
- •Patients with metastatic disease limited to the brain, unless planned a surgical excision, in which case tissue can be collected for screening
- •Severe hematopoietic, renal and/or hepatic insufficiency
- •Known contraindication to biopsy
- •Neoplastic pathology of different histology in the previous 5 years, except carcinoma in situ of cervical basal or squamous cell carcinoma of the skin, if adequately treated
研究组 & 干预措施
AZD2014
Selective and potent inhibitor of mTOR kinase
干预措施: Chemotherapy (Drug)
Selumetinib
selective and potent inhibitor of MEK1/2 kinases
干预措施: Chemotherapy (Drug)
Olaparib
Inhibitor of the PARP enzyme involved in DNA repair
干预措施: Chemotherapy (Drug)
Bicalutamide
nonsteroidal antiandrogen
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Comparison of progression-free survival
时间窗: from baseline to the end of treatment (up to 12 months)
Comparison of progression-free survival in the experimental arm vs control arm
次要结局
未报告次要终点