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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Collaborator: |
PharmaMar |
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00580112 |
Purpose
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 Breast Tumor |
Drug: Trabectedin; ET 743; Yondelis Drug: Trabectedin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Start Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Trabectedin Trabectedin 1.3mg/m2 3-hr iv infusion on Day 1 of every 21-day treatment cycle. Dexamethasone 4mg PO 24h and 12h before trabectedin followed by dexamethasone 20 mg iv 30 minutes before trabectedin followed by dexamethasone 4mg PO 24h 36h 48h 60h and 72h after the start of trabectedin
|
Drug: Trabectedin; ET 743; Yondelis
Drug: Trabectedin
Trabectedin, 1.3mg/m2 3-hr iv infusion on Day 1 of every 21-day treatment cycle. Dexamethasone, 4mg, PO 24h and 12h before trabectedin followed by dexamethasone 20 mg, iv 30 minutes before trabectedin, followed by dexamethasone, 4mg, PO 24h,36h,48h,60h,and 72h after the start of trabectedin
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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 (iv) 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 (iv) at a dose of 1.3 mg/m2 over 3-hours (hrs) on Day 1 of every 21-day treatment cycle. In addition, patients will be administered dexamethasone on Day 1 of each treatment cycle as follows: 4mg orally (PO) 24h and 12h before the trabectedin iv infusion, 20 mg, iv 30 minutes before the trabectedin infusion, and 4 mg PO 24h, 36h, 48h, 60h, 72h, after the start of trabectedin infusion.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 33 Study Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | Sr. Director Compound Development Team Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00580112 History of Changes |
| Other Study ID Numbers: | CR014764, ET-B-027-06 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Metastatic Breast Cancer triple negative profile HER2 overexpressing tumors |
BRAC1/2 mutation carriers Triple negative profile Neoplasm Metastasis |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Dexamethasone Trabectedin Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |