EUCTR2010-021191-29-IT进行中（未招募）不适用
A multicenter, open label study to assess the effect of trastuzumab + Whole Brain Radiotherapy (WBRT) on brain metastases from HER-2 positive breast cancer. - bHERt2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
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
- All
入选标准
- •1. Written informed consent;
- •2. Patients aged = 18 years;
- •3. Able to comply with the protocol procedures;
- •4. Patients with prior histological and/or cytological diagnosis of
- •breast carcinoma with HER-2 over expression (IHC 3+; IHC 2+
- •and amplified FISH or CISH or SISH) who have first evidence of
- •disease progression to the brain, regardless of control of
- •extracranial disease if present;
- •5. At least one measurable brain metastasis evaluated with brain
- •contrast MRI;
- •6. Patients for whom, according to investigator assessment, WBRT
- •is the best therapeutic option;
- •7. Symptomatic brain lesions and/or brain lesions as the only site
- •of metastatic disease and/or controlled extra-cerebral disease
- •with brain metastases;
- •8. Patients are eligible regardless of the type and number of prior
- •or concomitant trastuzumab-based therapies received. Patients
- •who received trastuzumab in the adjuvant setting can be
- •included in the study; 9. Performance Status (WHO) = 2;
- •10. Left ventricular ejection fraction (LVEF) = 50% at baseline
- •(assessed within 2 weeks prior to ICF signature ) as determined
- •by either 2D echocardiogram (ECHO) or MUGA;
- •11. Prior maximum cumulative dose of doxorubicin < 360 mg/m2 or
- •maximum cumulative dose of epirubicin < 720 mg/m2 or
- •equivalent.
- •12. Life expectancy = 3 months;
- •13. Adequate haematological function:
- •- Absolute neutrophils count (ANC) = 1.5 x 109/L AND
- •- Platelet count = 100 x 109/L AND
- •- Hemoglobin = 9 g/dL
- •14. Adequate liver function:
- •- Total bilirubin < 1.5 x upper limit of normal (ULN) AND
- •- Aspartate aminotransferase (AST), alanine aminotransferase
- •(ALT) < 5 x ULN;
- •15. Adequate renal function:
- •- Serum creatinine = 1.5 mg/dL
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of neoplastic meningitis;
- •2. Any prior radiotherapy to the brain;
- •3. Patients with non-controlled extra-cerebral disease who at the
- •time of enrolment, according to investigator judgment, are
- •eligible to a chemotherapy treatment not compatible with the
- •study protocol related timelines;
- •4. Patients for whom, according to investigator assessment,
- •stereotactic radiotherapy is the best therapeutic option;
- •5. Previous neoplasm, other than breast carcinoma, within 5 years
- •since the enrolment. Patients with previous diagnosis of in situ
- •carcinoma of the cervix and/or non-melanoma carcinomatous
- •lesions of the skin can be included into the study;
- •4. Uncontrolled claustrophobia;
- •5. Uncontrolled hypertension (systolic > 180 mmHg and/or
- •diastolic > 100 mmHg);
- •6. Clinically significant (i.e. active) cardiovascular disease, e.g.
- •cerebrovascular accident (CVA) and myocardial infarction (= 6
- •months before enrollment), unstable angina, congestive heart
- •failure NYHA class = II, serious cardiac arrhythmia requiring
- •medication during the study which might interfere with
- •regularity of the study treatment, or not controlled by
- •medication;
- •7. Pregnant or lactating females;
- •8. For women of childbearing potential (women < 2 years after last
- •menstruation) not able or willing to use an effective form of
- •contraception (patient and/or partner, e.g., surgical sterilization,
- •a reliable barrier method, birth control pills, or contraceptive
- •hormone implants) and to continue its use for the duration of
- •study treatment and for 6 months after the last dose of study
- •9. Known hyper-sensitivity to trastuzumab and any of its excipients or any other contraindications to treatment with
- •trastuzumab;
- •10. Evidence of ongoing or active infection, any other disease,
- •neurological, endocrine, pulmonary, hepatic or metabolic
- •dysfunction; physical examination finding or laboratory finding
- •giving reasonable suspicion of a disease or condition that
- •contraindicates the use of an investigational drug or puts the
- •patient at high risk for treatment-related complications;
- •11. Treatment with any other investigational agent, or participation
- •in another clinical trial within 28 days prior to enrollment.
- •12. High steroids dose (equivalent to dexamethasone > 16 mg/day).
- •13. Treatment with chemotherapy and/or lapatinib within 2 weeks
- •prior to ICF signature.
研究者
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