Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)

NCT00779285 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-07-14

Study results available
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Summary

The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.

Conditions

  • Breast Neoplasm

Interventions

DRUG

Pegylated Liposomal Doxorubicin

Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-08-31
Completion
2006-08-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00779285 on ClinicalTrials.gov