EUCTR2005-003493-19-GB进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
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
入选标准
- •1. Histologically confirmed breast cancer.
- •2. HER2-positive tumors. HER2 status must be re-confirmed 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 dose of Herceptin must have been given = 9 weeks prior to study day 1.
- •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:
- •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 10(9)/L, Platelet count < 100 x 10(9)/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 serum 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 investigators to be unable or unwilling to comply with the requirements of the protocol.
研究者
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