Overview

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

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
PharmaMar
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Trabectedin
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