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A Study of Effectiveness of Trabectedin for the Treatment of Patients With Specific Subtypes of Metastatic Breast Cancer
This study has been completed.

First Received on December 20, 2007.   Last Updated on December 27, 2011   History of Changes
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

Resource links provided by NLM:


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-+) [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Tumor response rate [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]

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 [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of Progression-free survival [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Changes in tumor volume [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Changes in tumoral radiological density [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to approximately 24 months ] [ Designated as safety issue: Yes ]

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

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 (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
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. Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580112

  Show 33 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 09, 2012