Spots Global Cancer Trial Database for An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
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Trial Identification
Brief Title: An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
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 ID: NCT00580112
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.
Detailed Description: This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center (when more than 1 hospital or medical school team work on a medical research study) study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants: Group A: triple negative profile for estrogen receptor, progesterone receptor and human estrogen receptor, Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carrier. Participants will receive trabectedin 1.3 milligram per square meter (mg/m\^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hour 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. Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment. Participants' safety will be monitored throughout the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, 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 Cedex, , France
, Villejuif, , France
, Jerusalem, , Israel
, Rehovot, , Israel
, Tel Hashomer, , Israel
, Tel-Aviv, , Israel
, Lubin, , Poland
, Rybnik, , Poland
, Szczecin, , Poland
Contact Details
Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Role: STUDY_DIRECTOR
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