Clinical trial NCT00082095: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Breast Cancer
Pegylated Liposomal Doxorubicin
Capecitabine
DOXIL
Xeloda
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
First posted: 2004-04-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time to disease progression
timeFrame: Up to disease progression or death
Secondary outcomes:
measure: Overall Response rate
timeFrame: Up to disease progression or death
measure: Overall survival
timeFrame: Up to 2 years after last patient is enrolled or death
measure: Number of patients with adverse events
timeFrame: Up to 1 month after intake of last dose of study medication
measure: The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30
timeFrame: Day 1 and end of treatment
measure: Subjective Significance Questionnaire (SSQ)
timeFrame: Day 1 and end of treatment
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Soquel
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Hazard
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Scarborough
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Clinton Township
country: United States
state: Michigan
city: St Louis Park
country: United States
state: Minnesota
city: Lebanon
country: United States
state: New Hampshire
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Armonk
country: United States
state: New York
city: New City
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Colchester
country: United States
state: Vermont
city: Everett
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
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.