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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar S.A. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00580112 |
The purpose of this study is to evaluate the effectiveness and safety of Trabectedin in three subpopulations of breast cancer patients.
Condition | Intervention | Phase |
---|---|---|
Breast Tumors |
Drug: Trabectedin; ET 743; Yondelis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 321 |
Study Start Date: | January 2007 |
This is an open-label, clinical trial evaluating the effectiveness and safety of trabectedin in three subpopulations of breast cancer patients: Group A: triple negative profile (ER-, PR-, HER-2-), Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial BRCA1 or BRCA2 mutation carrier. Each subtype is defined according to the estrogen, progesterone, and the Human Epidermal Growth Factor Receptor- 2 (HER-2) status in the primary tumor (present or overexpressing = positive or absent or do not overexpressing = negative) or the history of having BRCA1 or BRCA2 mutation genes. Trabectedin will be administered intravenously every three weeks. Patients will be assessed weekly physical exam and / or laboratory testing. Radiological examination will occur every 6 weeks to evaluate the patient's disease. Treatment will continue as long as the patient tolerating trabectedin and their disease is stable or improving. Duration of response, progression free-survival, exploratory evaluation of changes in tumor volume and changes in tumoral radiological density, safety profile and exploratory, hypothesis-generating pharmacoecogenomic analyses will be assessed.Patients are evaluable for safety if they received at least part of one infusion of trabectedin. Safety will be assessed by adverse events, laboratory measurements, and clinical examinations
Trabectedin will be administered intravenously at a dose of 1.3 mg/m2 over 3-hours on Day 1 of every 21-day treatment cycle
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR014764 |
Study First Received: | December 20, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00580112 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Breast Cancer HER2 overexpressing tumors triple negative profile BRAC1/2 mutation carriers |
Ecteinascidin 743 Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |