Back to resultsTo Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
Primary Purpose
Metastatic Breast Cancer
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pegylated liposomal doxorubicin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic breast cancer, Breast Cancer, Pegylated Liposomal Doxorubicin, Capecitabine, DOXIL, Xeloda
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 (doxorubicin)
Group 2 (capecitabine )
Arm Description
Pegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle. Cycle is repeated every 28 days, up to one year.
Capecitabine 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Response rate
Overall response rate is measured as the number of patient with complete and partial responses. It will be compared between patients treated with doxorubicin and capecitabine.
Overall survival
Overall survival is the duration from date of randomization to the date of death due to any cause during the study. It will be compared between patients treated with doxorubicin and capecitabine.
Number of patients with adverse events
Safety evaluated as "number of patients with adverse events" is compared between 2 treatment groups (doxorubicin and capecitabine).
The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30
The 30 item questionnaire to assess quality of life incorporates five functional scales: general physical symptoms, physical functioning, psychological distress, social functioning, and fatigue/malaise. Most items are rated on a 4 point Likert scale ranging from 0 = "not at all" to 4 = "very much". The effect of doxorubicin and capecitabine on the quality of life measured by the EORTC QLQ-C30 is assessed.
Subjective Significance Questionnaire (SSQ)
The SSQ consists of 4 items in which patients rate the degree to which they experienced an improvement or deterioration in their physical condition, emotional state, ability to enjoy their social life, and overall quality of life since there last QOL assessment.Each of the four items are rated on a 7 point Likert scale ranging from 0 = "very much worse" to 7 = "very much better". The effect of doxorubicin and capecitabine on the quality of life measured by the SSQ is assessed.
Full Information
NCT ID
NCT00082095
First Posted
April 29, 2004
Last Updated
October 8, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
1. Study Identification
Unique Protocol Identification Number
NCT00082095
Brief Title
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Metastatic breast cancer, Breast Cancer, Pegylated Liposomal Doxorubicin, Capecitabine, DOXIL, Xeloda
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (doxorubicin)
Arm Type
Experimental
Arm Description
Pegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle. Cycle is repeated every 28 days, up to one year.
Arm Title
Group 2 (capecitabine )
Arm Type
Active Comparator
Arm Description
Capecitabine 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.
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin
Other Intervention Name(s)
DOXIL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to disease progression
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.
Time Frame
Up to disease progression or death
Secondary Outcome Measure Information:
Title
Overall Response rate
Description
Overall response rate is measured as the number of patient with complete and partial responses. It will be compared between patients treated with doxorubicin and capecitabine.
Time Frame
Up to disease progression or death
Title
Overall survival
Description
Overall survival is the duration from date of randomization to the date of death due to any cause during the study. It will be compared between patients treated with doxorubicin and capecitabine.
Time Frame
Up to 2 years after last patient is enrolled or death
Title
Number of patients with adverse events
Description
Safety evaluated as "number of patients with adverse events" is compared between 2 treatment groups (doxorubicin and capecitabine).
Time Frame
Up to 1 month after intake of last dose of study medication
Title
The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30
Description
The 30 item questionnaire to assess quality of life incorporates five functional scales: general physical symptoms, physical functioning, psychological distress, social functioning, and fatigue/malaise. Most items are rated on a 4 point Likert scale ranging from 0 = "not at all" to 4 = "very much". The effect of doxorubicin and capecitabine on the quality of life measured by the EORTC QLQ-C30 is assessed.
Time Frame
Day 1 and end of treatment
Title
Subjective Significance Questionnaire (SSQ)
Description
The SSQ consists of 4 items in which patients rate the degree to which they experienced an improvement or deterioration in their physical condition, emotional state, ability to enjoy their social life, and overall quality of life since there last QOL assessment.Each of the four items are rated on a 7 point Likert scale ranging from 0 = "very much worse" to 7 = "very much better". The effect of doxorubicin and capecitabine on the quality of life measured by the SSQ is assessed.
Time Frame
Day 1 and end of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Fountain Valley
State/Province
California
Country
United States
City
Oxnard
State/Province
California
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United States
City
Soquel
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California
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United States
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Boca Raton
State/Province
Florida
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United States
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New Port Richey
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Florida
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United States
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Plantation
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Florida
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United States
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Atlanta
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Georgia
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United States
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Springfield
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Illinois
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United States
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Hazard
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Kentucky
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United States
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Shreveport
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Louisiana
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United States
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Scarborough
State/Province
Maine
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United States
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Baltimore
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Maryland
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United States
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Clinton Township
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Michigan
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United States
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St Louis Park
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Minnesota
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Lebanon
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New Hampshire
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United States
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Voorhees
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New Jersey
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United States
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Albuquerque
State/Province
New Mexico
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United States
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Armonk
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New York
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United States
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New City
State/Province
New York
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Portland
State/Province
Oregon
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United States
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Philadelphia
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Pennsylvania
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United States
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Fort Worth
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Texas
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United States
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Fredericksburg
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Texas
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Burlington
State/Province
Vermont
Country
United States
City
Colchester
State/Province
Vermont
Country
United States
City
Everett
State/Province
Washington
Country
United States
City
Vancouver
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34037241
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=613&filename=CR004645_CSR.pdf
Description
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
Learn more about this trial
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
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