EUCTR2017-003216-39-IT进行中（未招募）1 期
Clinical utility of a next generation sequencing-based oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP - SHARP
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
- 400
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
- •1.Provision of signed, written and dated informed consent for genetic research.
- •2.Patients with histologically confirmed breast adenocarcinoma.
- •3.Patient has radiologic evidence of inoperable locally advanced, or metastatic BC
- •4.Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier.
- •5.Presence of measurable target lesion according to RECIST criteria v1.1.
- •6.Age > 18 years and <75 years.
- •8.Patient must have received a minimum of 1 line of chemotherapy and\or endocrine therapies in the metastatic setting. Patients with HER2+ disease must have received 3 or more line of antiHER2 treatment (including dual blockade with pertuzumab/trastuzumab if reimbursed, TDM1 and lapatinib).
- •9.Life expectancy =3 months.
- •10.For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug.
- •11.Ability to swallow oral capsules
- •12.Normal echocardiogram at baseline (left ventricular ejection fraction [LVEF] >50% and shortening fraction [SF] >15%).
- •PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE
- •1) Patients who still meet the screening phase inclusion criteria
- •2) Patients will have had a minimum of 21 days gap from last chemotherapy or biological therapy administration prior to therapy modification.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients with known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti-convulsant medications for at least 2 weeks prior to the first dose of study medication.
- •2. History of clinically significant or uncontrolled cardiac disease, including angina, coronary artery bypass graft, angioplasty, vascular stent , myocardial infarction, atrial fibrillation within 6 months or history of ventricular arrhythmia, Congestive Cardiac Failure (CCF) or Ischaemic Heart Disease (IHD) with no limit of time (New York Heart Association [NYHA] functional classification = 3. Uncontrolled arterial hypertension (defined as systolic blood pressure = 140mmHg and/or diastolic blood pressure = 90mmHg with optimized antihypertensive therapy or patient treated with more than 2 antihypertensive agents) or systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg :
- •4. Participation in another clinical study with an investigational product (IP) during the last 30 days.
- •5. Bone metastases as the only site of biopsiable disease
- •6. Previous treatment with the study drugs or drugs of this class (e.g. Everolimus)
- •PATIENT RANDOMIZATION IN THE THERAPEUTIC PHASE
- •1) Patients who still meet the screening phase exclusion criteria
- •2) Residual toxicities of grade > 2 from previous treatments, with the exception of alopecia.
- •3) Major surgery within 30 days prior to entry into the study (excluding placement of vascular access or minor surgery within 14 days of entry into the study.
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