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Metastatic Breast CancerPhase 3NCT00082095

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

A Phase 3 study testing Pegylated liposomal doxorubicin and Capecitabine in people with Metastatic Breast Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Pegylated liposomal doxorubicin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
27 sitesUnited States
Study dates
Apr 2004to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Armonk, New York

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Boca Raton, Florida

  • Study site

    Burlington, Vermont

  • Study site

    Clinton Township, Michigan

  • Study site

    Colchester, Vermont

  • Study site

    Everett, Washington

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Fredericksburg, Texas

  • Study site

    Hazard, Kentucky

  • Study site

    Lebanon, New Hampshire

  • Study site

    New City, New York

  • Study site

    New Port Richey, Florida

  • Study site

    Oxnard, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    Scarborough, Maine

  • Study site

    Shreveport, Louisiana

  • Study site

    Soquel, California

  • Study site

    Springfield, Illinois

  • Study site

    Vancouver, Washington

  • Study site

    Voorhees Township, New Jersey

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Pegylated liposomal doxorubicin, Capecitabine
Keywords
Metastatic breast cancer, Breast Cancer, Pegylated Liposomal Doxorubicin, Capecitabine, DOXIL, Xeloda
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated liposomal doxorubicinDrug

    Also called DOXIL

    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.

  • CapecitabineDrug

    Also called Xeloda

    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.

Study groups in NCT00082095
Study groupRoleWhat they receive
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.
Receives: Drug: Pegylated liposomal doxorubicin
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.
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to disease progression or death

Secondary outcomes (5)

  1. 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.

    Measured: Up to disease progression or death

  2. 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.

    Measured: Up to 2 years after last patient is enrolled or death

  3. Number of patients with adverse events

    Safety evaluated as "number of patients with adverse events" is compared between 2 treatment groups (doxorubicin and capecitabine).

    Measured: Up to 1 month after intake of last dose of study medication

  4. 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.

    Measured: Day 1 and end of treatment

  5. 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.

    Measured: Day 1 and end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionDec 2005
  4. Study completionDec 2005

Why it stopped: The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082095
Sponsor's protocol ID
CR004645
Other IDs
DO03-21-022
Status last verified
Oct 2014
First submitted
29 Apr 2004
Last updated
9 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34037241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated liposomal doxorubicin and Capecitabine in people with Metastatic Breast Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to disease progression (time frame: Up to disease progression or death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.

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