EUCTR2011-006342-32-NL进行中（未招募）1 期
Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH / PHM: an open-label multicentre randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 80
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
- •-Patients with histologically proven HER-2 positive (IHC 3+ or or HER-2 gene amplification by in situ hybridization [FISH, SIS-Patients must have measurable (RECIST v. 1.1) or evaluable disease (please refer to chapter 7)
- •-Performance status (PS) 0-3 (WHO)
- •-Age = 70 years of age, or = 60 years old with required number of dependencies as described below :
- •65 – 69 in combination with functional restriction defined as limitation in at least 2 of 8 iADL or 1 of 6 ADL or Charlson comorbidity score > 2
- •60 – 64 in combination with functional restrictions defined as limitation in at least 3 of 8 iADL 2 of 6 ADL or Charlson comorbidity score > 3
- •-Life expectancy of more than 12 weeks
- •-Previous adjuvant chemotherapy/anti HER-2 therapy after surgery is allowed, given that the time interval from end of previous treatment to initiation of treatment for metastatic disease is =6 months.
- •-Up to one line of anti-HER therapy (trastuzumab or lapatinib) is allowed in combination with hormone therapy for hormone sensitive metastatic breast cancer.
- •-Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: (patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry [with the EXCEPTION of Glomerular Filtration Rate] are acceptable)
- •-Absolute neutrophil count > 1500 cells/mm3
- •-Platelet count > 100,000 cells/mm3
- •-Hemoglobin > 8.5 g/dL
- •-Total bilirubin = 1.5 upper limit of normal (ULN)
- •-SGOT (AST), SGPT (ALT), and alkaline phosphatase = 2.5× ULN (for alkaline phosphatase limit applies in the absence of bone metastases)
- •-Glomerular Filtration Rate (GFR) = 30 ml/min according to MDRD formula or Cockcroft and Gault Formula (see Appendix D)
- •-Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •-Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •mula or Cockcroft and Gault Formula (see Appendix D)H or CISH]) invasive breast cancer, based on the results of local laboratories of the participating centers. All histologies are eligible.
- •-Newly diagnosed or recurrent (after surgery) stage IV disease (TNM/AJCC v.7).
- •Evaluate the evolution of potential ageing biomarkers and their predictive potential for toxicity, decline in functionality and fraility status and outcome.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •-Current symptomatic brain metastases.
- •-Prior chemotherapy for metastatic disease.
- •-Prior treatment with pertuzumab.
- •-History of exposure to the following cumulative doses of anthracyclines:
- •Doxorubicin or liposomal doxorubicin > 360 mg/m2
- •Epirubicin > 720 mg/m2
- •Mitoxantrone > 120 mg/m2
- •Idarubicin > 90 mg/m2
- •If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.
- •-History of palliative radiotherapy within 14 days of /prior to randomization.
- •-History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin.
- •-Current uncontrolled hypertension (persistent systolic > 180 mmHg and/or diastolic > 100 mmHg) (with or without medication).
- •-LVEF below 50%.
- •-History of significant cardiac disease defined as:
- •Symptomatic CHF (NYHA classes II-IV, see Appendix C)
- •High-risk uncontrolled arrhythmias, i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
- •History of myocardial infarction within 6 months prior to randomization
- •Clinically significant valvular heart disease
- •angina pectoris requiring anti-angina treatment
- •-Peripheral neuropathy of Grade =3 per NCI CTCAE version 4.0.
- •current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures, known infection with HIV, active hepatitis B and/or hepatitis C virus)
- •-Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.
- •-History of receiving any investigational treatment within 28 days of randomization.
- •-History of intolerance (including Grade 3-4 infusion reaction) to trastuzumab.
- •-Unwillingness or inability to comply with the requirements of the protocol as assessed by the investigator.
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