EUCTR2007-000794-31-PL进行中（未招募）不适用
Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) inMetastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers
Pharma Mar, S.A.0 个研究点目标入组 321 人开始时间: 2007年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 321
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. Patient´s written informed consent before any clinical trial-specific procedure.
- •2. Woman 18 years-of-age or older.
- •3. Histologically proven diagnosis of progressive metastatic breast cancer either in
- •documented:
- •Group A: triple negative phenotype [Estrogen Receptor, Progesterone Receptor
- •and HER-2 negative status (surrogate of basal-like type)]. Patients will
- •be eligible if they had received prior therapy with an anthracycline and taxanes, including adjuvant or neoadjuvant therapy, but no more than three
- •prior chemotherapy regimens for metastatic disease. NOTE: re-treatment with
- •the same regimen or its components after a progression-free interval of 6 months
- •or longer will be considered a second regimen. This arm is closed for recruitment.
- •Group B: HER-2 overexpressing breast cancer. Patients will be eligible if they
- •have progressive metastatic disease following treatment with trastuzumab-based
- •regimens or other HER-2 targeted therapy containing regimens, but no more than three prior regimens that contain HER-2 directed therapy and chemotherapy for metastatic disease are allowed. NOTE: re-treatment with the same regimen or its components after a progression-free interval of 6 months or longer will be considered as second regimen.
- •Group C: Familial BRCA1 or BRCA2 mutation carriers. Patients will be eligible if
- •they have developed progressive metastatic disease after at least one prior
- •chemotherapy regimen in the adjuvant or metastatic setting. There is no limit to the
- •maximal number of prior therapies allowed
- •4. Measurable disease as defined by the radiological (CT-scan and MRI) Response
- •Evaluation Criteria in Solid Tumors (RECIST) Guidelines. If the only indicator lesion
- •is in a previously irradiated area, the recurrence must be biopsy proven.
- •5. Patients with bone metastases currently receiving biphosphonates for palliation
- •will be eligible if other sites of measurable disease are present.
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- •7. Hematologic variables:
- •Hemoglobin =9 g/dL
- •Absolute neutrophil count (ANC) =1,500/µL, and
- •Platelet count =100,000/µL.
- •8. Serum creatinine = 1.5 mg/dL or creatinine clearance = 30 mL/min
- •9. Creatinine phosphokinase (CPK) = 2.5 ULN.
- •10. Hepatic function variables
- •Total bilirubin = ULN.
- •Total alkaline phosphatase = 2.5 ULN, or if > 2.5 ULN consider alkaline
- •phosphatase liver fraction or GGT or 5’ nucleotidase must be = ULN, if the
- •elevation could be osseous in origin.
- •AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine
- •transaminase [SGPT]) must be =2.5 x ULN.
- •11. Albumin = 25 g/l.
- •12. Complete recovered from the acute toxicity of any prior treatment. The presence
- •of alopecia or NCI-CTC grade 1 symptomatic peripheral neuropathy is allowed.
- •13. Patients may have CNS metastases if stable (no evidence of progression) for at
- •least 3 months after local therapy.
- •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 exposure to trabectedin.
- •2. Known hypersensitivity to any of the components of the trabectedin i.v.
- •formulation or dexamethasone.
- •3. More than three prior chemotherapy regimens for metastatic disease for group A
- •and B. NOTE:re-treatment with the same regimen or its components after a
- •progression-free interval of 6 months or more is considered a second regimen.
- •4. Pregnant or lactating women or any women of childbearing potential who is not
- •employing adequate contraception. Acceptable methods of contraception include;
- •IUD, and double barrier (condom with a contraceptive sponge or contraceptive
- •suppository). Use of hormonal contraception is not acceptable during this clinical
- •5. Completion of prior therapy: less than 2 weeks from radiation therapy (radiated
- •lesions may not serve as measurable disease) or last dose of hormonal therapy, less
- •than 3 weeks from prior chemotherapy or biological therapy (all acute toxicities must
- •be adequately recovered as per inclusion criteria # 12), less than 4 weeks with any
- •investigational agent.
- •6. History of another neoplastic disease (except basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer.Group C patients can be enrolled with less than 5 years remission from another neoplastic disease; however, appropriate biopsy confirming current metastasic breast cancer is mandatory.
- •7. Patients with known leptomeningeal disease.
- •8. Other serious illnesses, such as:
- •Congestive heart failure or angina pectoris; myocardial infarction within 1 year
- •before enrollment; uncontrolled arterial hypertension or arrhythmias
- •Psychiatric disorder that prevents compliance with protocol
- •Active viral hepatitis; or chronic liver disease
- •Active infection
- •Any other unstable medical conditions
- •9. Patients with a life expectancy < 3 months.
研究者
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