To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

Johnson & Johnson (J&J)

Status and phase: Terminated; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Capecitabine; Drug: Pegylated liposomal doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082095

DO03-21-022 (Other Identifier)

CR004645

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Group 1 (doxorubicin)

Experimental group

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.

Treatment:

Drug: Pegylated liposomal doxorubicin

Group 2 (capecitabine )

Active Comparator group

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.

Treatment:

Drug: Capecitabine