EUCTR2005-003493-19-IT进行中（未招募）不适用
An exploratory phase II, single arm, multicenter study to evaluate the efficacy and safety of the combination of pertuzumab and Herceptin (trastuzumab) in patients with HER2-positive metastatic breast cancer
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
- 62
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. Histologically confirmed breast cancer. 2. HER2-positive tumors. HER2 status must be reconfirmed in a central lab before study entry. 3. Availability of a FFPE tumor tissue sample from primary tumor for eligibility (HER2-status) testing and biomarker assessment. 4. Patients with metastatic breast cancer, who have progressed on Herceptin-based therapy as last treatment for metastatic disease. 5. Patients with ≤ 3 chemotherapy regimens prior to study entry. 6. The last Herceptin dose must be ≤ 9 weeks before study day 1 for patients in cohorts 1 and 2 and ≥ 4 weeks before study day 1 for patients in cohort 3. 7. At least one measurable lesion according to RECIST. A measurable lesion in a previously irradiated area has to reveal clear signs of progression (increase in size of ≥ 50% or new lesions) 8. At least 4 weeks since prior radiotherapy, with full recovery. 9. At least 4 weeks since major surgery, with full recovery 10. LVEF of ≥ 55 % or local parameter for ≥ LLN by echocardiography or MUGA. 11. Performance status ECOG ≤ 2. 12. Age ≥ 18 years 13. Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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. Prior treatment with any targeted therapy other than Herceptin, such as cetuximab, bevacizumab, gefitinib or with anticancer vaccine. 2. Prior exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicine > 360 mg/m2, epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2 3. Known asymptomatic decreases in LVEF to below 50% absolute value during Herceptin treatment. 4. Patients with known history of any cardiac adverse event which according to the criteria of the investigator was related to Herceptin therapy. 5. History of congestive heart failure (any NYHA grading),unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease. 6. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma 7. Absolute Neutrophil Count (ANC) < 1.5 x 109/L, Platelet count < 100 x 109/L or Hb < 10 g/dL. 8. Impaired liver function: serum [total] bilirubin > 1.5 x ULN, AST, ALT > 2.5 x ULN, (> 5 x ULN in patients with liver metastases). 9. Serum creatinine > 2 x ULN 10. History or clinical evidence of brain metastases. 11. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture). 12. Patients with severe dyspnea at rest requiring supplementary oxygen therapy due to complications of advanced malignancy. 13. Positive pregnancy test in women of childbearing potential 14. Patients with reproductive potential not willing to use effective method of contraception. 15. Pregnant or lactating women. 16. Patients with known infection with HIV, HBV, HCV. 17. Known hypersensitivity to Herceptin, murine proteins, or to any of its excipients. 18. Treatment with any investigational drug within 28 days prior to the start of the study. 19. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究者
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