EUCTR2009-012019-17-PT进行中（未招募）1 期
A randomised, multicentre, multinational Phase II study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy or concomitantly with a non-anthracycline based chemotherapy regimen, as neoadjuvant therapy for patients with locally advanced, inflammatory or early stage HER2-positive breast cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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 with locally inflammatory or early stage, unilateral and histologically confirmed invasive breast cancer. The initial breast cancer asessment should be performed by a physician with experience in surgery for breast cancer. Patients with inflammatory breast cancer must be able to have a core needle biopsy.
- •2. Primary tumor > 2cm in diameter.
- •3. HER-pos breast cancer confirmed by a central laboratory. Tumors must be HER2 3+ by IHC or FISH/CISH +(FISH/CISH pos mandatory for HER 2 2+ tumors).
- •4. Availability of FFPE tissue for central confirmation of HER2 eligibility.
- •5. Female patients, age>=18 years.
- •6. Baseline LVEF>=55%.
- •7. Performance status ECOG<=1.
- •8. At least 4 weeks since major unrelated surgery, with full recovery.
- •9. A negative pregnancy test must be available for pre-menopausal women and for women less than 12 months after the onset of menopause.
- •10. For women of childbearing potential agreement to use a highly effective , non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment.
- •11. 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, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- •4. Inadequate bone marrow function (e.g. Absolute Neutrophil Count (ANC) < 1.5 x 109/L, Platelet count < 100 x 109/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 (exceptions: 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 require continuous oxygen therapy.
- •9. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture).
- •10. Patients with insulin-dependent diabetes.
- •11. Pregnant and/or lactating women.
- •12. Patients with reproductive potential not willing to use a ‘highly effective’ method of contraception or two ‘effective’ methods of contraception as described in General Inclusion Criterion number 10.
- •13. Received any investigational treatment within 4 weeks of study start.
- •14. Patients with known infection with HIV, HBV, HCV.
- •15. Current chronic daily treatment with corticosteroids (dose of >10 mg methylprednisolone, or equivalent [excluding inhaled steroids])
- •16. Known hypersensitivity to any of the study drugs or excipients.
- •17. Patients assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
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