Study Stopped
The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
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
2 other identifiers
interventional
62
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2004
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 29, 2004
CompletedFirst Posted
Study publicly available on registry
April 30, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedOctober 9, 2014
October 1, 2014
1.7 years
April 29, 2004
October 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to disease progression
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.
Up to disease progression or death
Secondary Outcomes (5)
Overall Response rate
Up to disease progression or death
Overall survival
Up to 2 years after last patient is enrolled or death
Number of patients with adverse events
Up to 1 month after intake of last dose of study medication
The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30
Day 1 and end of treatment
Subjective Significance Questionnaire (SSQ)
Day 1 and end of treatment
Study Arms (2)
Group 1 (doxorubicin)
EXPERIMENTALPegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle. Cycle is repeated every 28 days, up to one year.
Group 2 (capecitabine )
ACTIVE COMPARATORCapecitabine administered orally at a dosage of 2000 mg/m2/day (1000 mg/m2 BID) for 14 consecutive days followed by a 7-day rest period. Cycle is repeated every 21 days, up to one year.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Oxnard, California, United States
Unknown Facility
Soquel, California, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Hazard, Kentucky, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Scarborough, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Clinton Township, Michigan, United States
Unknown Facility
Saint Louis Park, Minnesota, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Armonk, New York, United States
Unknown Facility
New City, New York, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Fredericksburg, Texas, United States
Unknown Facility
Burlington, Vermont, United States
Unknown Facility
Colchester, Vermont, United States
Unknown Facility
Everett, Washington, United States
Unknown Facility
Vancouver, Washington, United States
Related Publications (1)
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PMID: 34037241DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2004
First Posted
April 30, 2004
Study Start
April 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
October 9, 2014
Record last verified: 2014-10