An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00580112
• Date of registration: 20/12/2007
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
• Scientific 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
• Date of first enrolment: June 2007
• Target sample size: 127
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00580112
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Israel, Poland, United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: Dexamethasone

Drug: Trabectedin

Primary Outcome(s)

Percentage of Participants With Confirmed Objective Response (OR) by Investigators' Assessment [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER) [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Secondary Outcome(s)

Progression-Free Survival (PFS) by Independent Expert Review (IER) [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Duration of Response (DR) by Independent Expert Review (IER) [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Duration of Response (DR) by Investigators' Assessment [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Number of Participants With Changes in Tumor Volume [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Progression-Free Survival (PFS) by Investigators' Assessment [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Number of Participants With Changes in Tumoral Radiological Density [Time Frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)]

Secondary ID(s)

CR014764

ET-B-027-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaMar