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A Study of Effectiveness of Trabectedin for the Treatment of Patient With Specific Subtypes of Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., December 2008
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar S.A.
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
Drug: Trabectedin; ET 743; Yondelis
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Ecteinascidin 743
U.S. FDA Resources
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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • To determine the objective response rate with trabectedin in patients with the following metastatic breast cancer subtypes:Group A: triple negative profile (ER-, PR-, HER-2-) Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-+)

Secondary Outcome Measures:
  • Duration of response, Progression-free survival, Exploratory evaluation of changes in tumor volume and changes in tumoral radiological density, Safety profile, Exploratory, hypothesis-generating pharmacogenomic analyses

Estimated Enrollment: 321
Study Start Date: January 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's written informed consent before any clinical trial-specific procedure
  • Diagnosis of progressive metastatic breast cancer
  • Measurable disease (Patients with bone metastases currently receiving biphosphonates for palliation will be eligible if other sites of measurable disease are present)
  • Adequately recovered from the acute toxicity of any prior treatment

Exclusion Criteria:

  • Prior exposure to trabectedin
  • More than three prior chemotherapy regimens for metastatic disease
  • Pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
  • 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)
  • Known clinically relevant CNS metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580112

Contacts
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

  Show 28 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar S.A.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Metastatic Breast Cancer
HER2 overexpressing tumors
triple negative profile
BRAC1/2 mutation carriers

Study placed in the following topic categories:
Ecteinascidin 743
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009