Clinical trial NCT00580112: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms
Trabectedin
Yondelis
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2007-12-24
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Participants with histologically proven diagnosis of progressive metastatic breast cancer
* 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 previous exposure to trabectedin
* 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

Primary outcomes:
measure: Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER)
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Percentage of Participants With Confirmed Objective Response (OR) by Investigators' Assessment
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Secondary outcomes:
measure: Duration of Response (DR) by Independent Expert Review (IER)
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Duration of Response (DR) by Investigators' Assessment
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Progression-Free Survival (PFS) by Independent Expert Review (IER)
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Progression-Free Survival (PFS) by Investigators' Assessment
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Number of Participants With Changes in Tumor Volume
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
measure: Number of Participants With Changes in Tumoral Radiological Density
timeFrame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to 30 days after last dose of study drug
Locations:
city: Sedona
country: United States
state: Arizona
city: Denver
country: United States
state: Colorado
city: Torrington
country: United States
state: Connecticut
city: Indianapolis
country: United States
state: Indiana
city: Westminster
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Amsterdam
country: United States
state: New York
city: New York
country: United States
state: New York
city: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Yakima
country: United States
state: Washington
city: Bourdeaux
country: France
city: Marseille
country: France
city: Saint Herblain
country: France
city: Strasbourg Cedex
country: France
city: Villejuif
country: France
city: Jerusalem
country: Israel
city: Rehovot
country: Israel
city: Tel Hashomer
country: Israel
city: Tel-Aviv
country: Israel
city: Lubin
country: Poland
city: Rybnik
country: Poland
city: Szczecin
country: Poland
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.