A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
60 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
This is an open-label (all people know the identity of the intervention), randomized (the
study medication is assigned by chance), multicenter study comparing with pegylated
liposomal doxorubicin (PLD) with capecitabine as first line chemotherapy of metastatic
breast cancer in women 60 years and older. The study consists of a screening Phase (up to 14
days prior to treatment), treatment phase (up to 1 year), and post-treatment follow-up
phase. The planned duration of treatment was 1 year in the absence of disease progression or
unacceptable toxicity. Approximately 300 patients will be enrolled and randomly assigned to
receive 1 of 2 treatment groups (PLD or capecitabine). Safety evaluations will consist of
vital sign examination, physical examination, incidence and severity of adverse events, and
laboratory tests findings and will be followed throughout the study.
Inclusion Criteria:
- Clinically or pathologically proven metastatic breast cancer
- Eastern Cooperative Oncology Group performance status between 0-2
- Adequate bone marrow, renal and liver functions within normal limits
- Left ventricular ejection fractions more than 45% measured by multiple gated
acquisition scan or echocardiogram within 6 weeks of randomization
Exclusion Criteria:
- Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant
setting and hormonal therapy in metastatic setting is allowed)
- Prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant
setting (prior anthracyclines up to certain dose limit is allowed)
- Evidence of brain metastases unless previously treated and asymptomatic for 3 months
or greater
- History of cardiac disease with New York Heart Association Class II or greater or
clinical evidence of congestive heart failure
- Anthracycline resistant disease (locally recurrent or metastatic disease while on
adjuvant anthracycline therapy or relapse less than 18 months after therapy
completion)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to disease progression
Outcome Description:
Time to disease progression is the duration in months from the date of randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study. Time to disease progression will be compared between patients treated with doxorubicin and capecitabine.
Outcome Time Frame:
Up to disease progression or death
Safety Issue:
No
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR004645
NCT ID:
NCT00082095
Start Date:
April 2004
Completion Date:
December 2005
Related Keywords:
- Metastatic Breast Cancer
- Metastatic breast cancer
- Breast Cancer
- Pegylated Liposomal Doxorubicin
- Capecitabine
- DOXIL
- Xeloda
- Breast Neoplasms
Name | Location |
|---|
