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临床试验/EUCTR2008-008276-14-FR
EUCTR2008-008276-14-FR进行中（未招募）1 期

A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapy

F. Hoffmann-la Roche Ltd0 个研究点目标入组 40 人开始时间: 2009年3月24日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
40
研究概览入排标准研究者记录与标识符相似试验

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

  • •Signed Informed Consent Form
  • •Age = 18 years
  • •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • •Histologically documented breast cancer
  • •Locally advanced or metastatic breast cancer that has progressed on the patient’s most recent prior regimen
  • •- For the purposes of this study, locally advanced breast cancer is defined as unresectable local or regional disease that has previously been treated with radiation therapy, chemotherapy, and HER2-directed therapy.
  • •HER2-positive breast cancer documented as fluorescence in situ hybridization (FISH)-positive, immunohistochemistry (IHC) 3 + or chromogenic in situ hybridization (CISH)-positive by local laboratory assessment
  • •Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central
  • •laboratory HER2 status testing and other exploratory assessments
  • •Prior trastuzumab in any line of therapy
  • •Prior chemotherapy combined with HER2-targeted therapy for locally advanced or metastatic disease
  • •No prior T-DM1 or pertuzumab therapy
  • •Measurable disease, defined as at least one lesion = 2 cm on computed tomography (CT) scan or = 1 cm on spiral CT scan
  • •Cardiac ejection fraction = 55% by either ECHO or MUGA scan
  • •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to first study treatment:
  • •- Absolute neutrophil count = 1500 cells/mm3
  • •- Platelet count = 100,000 cells/mm3
  • •- Hemoglobin = 9.0 g/dL
  • •- Albumin = 2.5 g/dL
  • •- Total bilirubin = 1.5 × ULN
  • •- SGOT (AST) and SGPT (ALT) = 2.5 × ULN, with the following exception: Patients with documented liver metastases: AST and/or ALT = 5 × ULN
  • •- Serum creatinine = 1.5 mg/dL, or creatinine clearance = 50 mL/min based on Cockroft-Gault glomerular filtration rate (GFR) estimation:
  • •- (140 - age) × (weight in kg) × (0.85 if female)/72 × serum creatinine
  • •For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner [e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants]), and to continue its use for the duration of the study
  • •Life expectancy = 90 days
  • •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

  • •Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions:
  • •- Hormone-replacement therapy or oral contraceptives
  • •- Palliative radiation therapy involving = 25% of marrow-bearing bone within 14 days prior to first study treatment
  • •History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
  • •Peripheral neuropathy of Grade = 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy
  • •History of exposure to the following cumulative doses of anthracyclines:
  • •- Doxorubicin > 500 mg/m2 (or the relevant equivalent dose of another anthracycline)
  • •- Liposomal doxorubicin > 900 mg/m2
  • •- Epirubicin > 720 mg/m2
  • •History of clinically significant cardiac dysfunction, including:
  • •- Current uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg), or unstable angina
  • •- History of symptomatic CHF (Grade > 3 by NCI CTCAE or Class > II by New York Heart Association [NYHA] criteria, or serious cardiac arrhythmia requiring treatment, with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia
  • •- History of myocardial infarction within 6 months prior to first study treatment
  • •- Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
  • •Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • •Pregnancy or lactation
  • •Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
  • •Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment
  • •Symptomatic hypercalcemia requiring use of bisphosphonate therapy at the time of, or within 21 days of, the first study treatment
  • •- Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
  • •Brain metastases that are either:
  • •- Untreated or
  • •- Require any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days of the first study treatment.
  • •History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome

研究者

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