An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
NCT ID: NCT00580112
Last Updated: 2014-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2007-06-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
Participants with triple negative phenotype: estrogen receptor, progesterone receptor and human estrogen receptor-2 (HER-2) negative status for breast cancer (abnormal tissue that grows and spreads in the body until it kills) will receive trabectedin 1.3 milligram per meter square (mg/m\^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hours (hrs) every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72hrs after the start of study drug infusion from Day 1 to 3.
Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Trabectedin
Trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Group B
Participants with overexpressing HER-2 breast cancer will receive trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 milligram (mg) orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Trabectedin
Trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Group C
Participants with familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carriers cancer will receive trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Along with study drug participants will be given dexamethasone 4 mg orally 24 hrs and 12hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion from Day 1 to 3.
Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Trabectedin
Trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Interventions
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Dexamethasone
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Trabectedin
Trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
* Participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
* Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
* Participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)
Exclusion Criteria
* Participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
* Pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
* Completion of previous therapy : Less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
* Participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis
18 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Sedona, Arizona, United States
Denver, Colorado, United States
Torrington, Connecticut, United States
Indianapolis, Indiana, United States
Westminster, Maryland, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Amsterdam, New York, United States
New York, New York, United States
Bedford, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Norfolk, Virginia, United States
Salem, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Yakima, Washington, United States
Bourdeaux, , France
Marseille, , France
Saint-Herblain, , France
Strasbourg, , France
Villejuif, , France
Jerusalem, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Lubin, , Poland
Rybnik, , Poland
Szczecin, , Poland
Countries
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References
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Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Goncalves A, Campone M, Lardelli P, Kahatt C, Nieto A, Cullell-Young M, Lubinski J. Activity of trabectedin in germline BRCA1/2-mutated metastatic breast cancer: results of an international first-in-class phase II study. Ann Oncol. 2014 Jun;25(6):1152-8. doi: 10.1093/annonc/mdu134. Epub 2014 Apr 1.
Related Links
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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
Other Identifiers
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ET-B-027-06
Identifier Type: OTHER
Identifier Source: secondary_id
CR014764
Identifier Type: -
Identifier Source: org_study_id
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