Status:
TERMINATED
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00082095
Start Date
April 1 2004
End Date
December 1 2005
Last Update
October 9 2014
Active Locations (27)
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1
Fountain Valley, California, United States
2
Oxnard, California, United States
3
Soquel, California, United States
4
Boca Raton, Florida, United States