EUCTR2007-000794-31-FR进行中（未招募）1 期
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6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- •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, a taxane and
- •capecitabine, 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.
- •Group B: HER-2 overexpressing breast cancer. Patients will be eligible if they
- •have progressive metastatic disease following treatment with anthracyclines,
- •taxanes and capecitabine, with trastuzumab or other HER-2 target agent , but no
- •more than three prior chemotherapy regimens 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
- •Group C: Familial BRCA1 or BRCA2 mutation carriers. Patients will be eligible if
- •they had received prior therapy with an anthracycline, a taxanes and
- •capecitabine, including adjuvant or neoadjuvant therapy, without prior lines
- •limitation.
- •4. Measurable disease as defined in the 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. Adequately recovered from the acute toxicity of any prior treatment
- •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
- •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. Less than 4 weeks from radiation therapy or last dose of hormonal therapy,
- •biological therapy, therapy with any investigational agent, or chemotherapy (6
- •weeks if a nitrosurea or mitomycin C).
- •6. History of another neoplastic disease (except basal cell carcinoma or cervical
- •carcinoma in situ adequately treated) unless in remission for 5 years or longer.
- •7. Known clinically relevant CNS metastases.
- •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
研究者
相似试验
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 carriersProgressive metastatic breast cancer previously treated in the following subpopulation of patients:Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor andHER-2 negative status (surrogate of basal-like type)Group B: HER-2 overexpressing tumors.Group C: Familial BRCA1 or BRCA2 mutation carriersMedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastaticEUCTR2007-000794-31-PLPharma Mar, S.A.321
进行中（未招募）
不适用
Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers. - NDEUCTR2007-000794-31-ITPHARMA MAR321
进行中（未招募）
1 期
A research study to reduce the use of chemotherapy in breast cancer treatment.Post menopausal patients with histologically confirmed estrogen receptor positive, HER2 positive primary breast cancerMedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-005067-40-ITINTERNATIONAL BREAST CANCER STUDY GROUP144
进行中（未招募）
1 期
A research study to reduce the use of chemotherapy in breast cancer treatment.Postmenopausal women with histologically confirmed estrogen receptor positive, HER2 positive primary breast cancerMedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-005067-40-BEETOP IBCSG Partners Foundation144
进行中（未招募）
1 期
Clinical trial to assess the efficacy and toxicity of induction and consolidation with CPX-351 for patients aged 60 to 75 years with secondary or high-risk acute myeloid leukemiaewly diagnosed secondary or high risk AMLMedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2018-004353-24-ESFundación PETHEMA59