Suspended

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

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What is being tested

Pegylated liposomal doxorubicin

+ Capecitabine
Drug
Who is being recruted

Metastatic Breast Cancer

Over 60 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2004

See protocol details

Summary

Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: October 9, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleA 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 
Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: October 9, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
62 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Metastatic Breast Cancer
Criteria
4 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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 II
Active Comparator
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.
Study Objectives
Primary Objectives

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 Objectives

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 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.

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

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 27 locations
Suspended
Unknown FacilityFountain Valley, United StatesSee the location
Suspended
Unknown FacilityOxnard, United States
Suspended
Unknown FacilitySoquel, United States
Suspended
Unknown FacilityBoca Raton, United States
Suspended27 Study Centers