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To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

NCT00082095 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2014-10-09

No results posted yet for this study

Summary

The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

Conditions

Interventions

DRUG

Pegylated liposomal doxorubicin

Type=exact number, unit=mg/m2, number=40, form=infusion, route=intravenous. Pegylated liposomal doxorubicin will be administered on Day 1 of each cycle. Cycle will be repeated every 28 days, up to 1 year.

DRUG

Capecitabine

Type=exact number, unit=mg, number=500, form=tablet, route=oral. Capecitabine will be administered at a dosage of 1000 mg/m2 twice daily for 14 consecutive days followed by a 7-day rest period. Cycle is repeated every 21 days, up to one year.

Sponsors & Collaborators

  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00082095 on ClinicalTrials.gov