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Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)

NCT00604968 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-06-07

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Caelyx (pegylated liposomal doxorubicin; SCH 200746)

Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-07
Primary Completion
2009-10-16
Completion
2009-10-16

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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 NCT00604968 on ClinicalTrials.gov