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

NCT ID: NCT00082095

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-12-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (doxorubicin)

Pegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle. Cycle is repeated every 28 days, up to one year.

Group Type: EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type: DRUG

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.

Group 2 (capecitabine )

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.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

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.

Interventions

Pegylated liposomal doxorubicin

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

Capecitabine

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.

Intervention Type: DRUG

Other Intervention Names

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Fountain Valley, California, United States

Oxnard, California, United States

Soquel, California, United States

Boca Raton, Florida, United States

New Port Richey, Florida, United States

Plantation, Florida, United States

Atlanta, Georgia, United States

Springfield, Illinois, United States

Hazard, Kentucky, United States

Shreveport, Louisiana, United States

Scarborough, Maine, United States

Baltimore, Maryland, United States

Clinton Township, Michigan, United States

Saint Louis Park, Minnesota, United States

Lebanon, New Hampshire, United States

Voorhees Township, New Jersey, United States

Albuquerque, New Mexico, United States

Armonk, New York, United States

New City, New York, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Fort Worth, Texas, United States

Fredericksburg, Texas, United States

Burlington, Vermont, United States

Colchester, Vermont, United States

Everett, Washington, United States

Vancouver, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34037241 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=613&filename=CR004645_CSR.pdf

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

Other Identifiers

DO03-21-022

Identifier Type: OTHER

Identifier Source: secondary_id

CR004645

Identifier Type: -

Identifier Source: org_study_id