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. - ND

• Conditions: Metastatic Breast Cancer with triple negative profile (ER-, PR-, HER2-),HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers.; MedDRA version: 6.1Level: PTClassification code 10055113

• Registration Number: EUCTR2007-000794-31-IT
• Lead Sponsor: PHARMA MAR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 321

Inclusion Criteria

1.PatientŽs 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 regimen. 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 more than or equal to 9 g/dL Absolute neutrophil count (ANC) more than or equal to 1,500/µL, and Platelet count more than or equal to 100,000/µL. 8. Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance more than or equal to 30 mL/min 9. Creatinine phosphokinase (CPK) less than or equal to 2.5 ULN. 10. Hepatic function variables Total bilirubin less than or equal to ULN. Total alkaline phosphatase less than or equal to 2.5 ULN, or if > 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5? nucleotidase must be less than or equal to ULN, if the elevation could be osseous in origin. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be less than or equal to 2.5 x ULN. 11 Albumin more than or equal to 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

Exclusion Criteria

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 trial. 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 ble during this clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified