EUCTR2007-001105-13-AT进行中（未招募）不适用
A randomised, multicenter, multinational Phase II study on trastuzumab plus docetaxel versus trastuzumab plus docetaxel plus pertuzumab versus trastuzumab plus pertuzumab versus pertuzumab and docetaxel in patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. - NEOSPHERE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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. Female patients =18 years with locally advanced, inflammatory or early
- •stage, unilateral and histologically confirmed invasive breast cancer.
- •2. Primary tumor >2cm in diameter.
- •3. HER2 positive confirmed by a central laboratory. Tumors must be HER2+++
- •by IHC or FISH/CISH + (FISH/CISH mandatory for HER2 ++ tumors).
- •4. Availability of FFPE tissue for central confirmation of HER2 eligibility (FFPE
- •tumor tissue will subsequently be used for assessing status of biomarkers).
- •5. Baseline LVEF of = 55% (measured by echocardiogram or MUGA).
- •6. Performance status ECOG Scale = 1.
- •7. At least 4 weeks since major unrelated surgery, with full recovery.
- •8. A negative pregnancy test must be available for pre-menopausal women and for
- •women less than 2 years after the onset of menopause.
- •9. Signed informed consent.
- •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. Metastatic disease (Stage IV) or bilateral breast cancer.
- •2. Previous anticancer therapy or radiotherapy for any malignancy.
- •3. Other malignancy, except for carcinoma in situ of the cervix or basal cell
- •4. Inadequate bone marrow function (e.g. Absolute Neutrophil Count (ANC)
- •<1.5 x 1,000,000,000/L, Platelet count < 100 x 1,000,000,000/L and
- •Hb < 9 g/dL ).
- •5. Impaired liver function: (e.g. serum [total] bilirubin > 1.25 x ULN (with the
- •exception of Gilbert’s syndrome), AST, ALT > 1.25 x ULN, albumin < 25 g/L
- •6. Inadequate renal function, serum creatinine >1.5 x ULN.
- •7. Uncontrolled hypertension (systolic > 150 and/or diastolic > 100), unstable
- •angina, CHF of any NYHA classification, serious cardiac arrhythmia requiring
- •treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia),
- •history of myocardial. infarction within 6 months of enrollment, or LVEF < 55%.
- •8. Dyspnea at rest or other diseases which requires continuous oxygen therapy.
- •9. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant
- •cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture).
- •10. Subjects with insulin-dependent Diabetes
- •11. Pregnant and/or lactating women.
- •12. Subjects with reproductive potential not willing to use highly effective non-hormonal method of contraception or two effective forms of non-hormonal contraception. Contraception use must continue for the duration of study treatment and for at least 6 months post discontinuation of study treatment. For details please see section 7.2.4.
- •13. Received any investigational treatment within 4 weeks of study start.
- •14. Subjects with known infection with HIV, HBV, HCV.
- •15. Known hypersensitivity to any of the study drugs or excipients.
- •16. Subjects assessed by the investigator to be unable or unwilling to comply with
- •the requirements of the protocol.
研究者
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