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Breast CancerPhase 3NCT00266799

The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)

A Phase 3 study testing Pegylated liposomal doxorubicin (SCH 200746) and Capecitabine in people with Breast Cancer, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pegylated liposomal doxorubicin (SCH 200746) and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
13 Jan 2006to 18 Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients must be female.
  • Patients must have metastatic disease of a cytological or histological confirmed breast cancer.
  • Patients must be 18 years or older.
  • Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Patients must have a sufficient life expectancy to be treated with chemotherapy.
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  • Patients must be willing and able to complete study questionnaires.
  • Patients must have adequate renal function as evidenced by serum creatinine <=1.5 mg/dL, or a creatinine clearance of >=45 mL/min (if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL).
  • Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin >=9.0 g/dL, and platelet count >=100x10^9/L.
  • Patients must have adequate liver function as evidenced by bilirubin of <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase <=3 times, ULN unless related to liver metastasis.
  • Patients must have Sodium and Potassium values within normal limits.
  • Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy.
  • Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Who cannot join

  • History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had
  • hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy).
  • Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded.
  • Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients.
  • Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency.
  • Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine.
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  • Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted.
  • Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result
  • immunologically Her2neu 3+ positive
  • Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive
  • History of treatment with capecitabine
  • History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine).
  • Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy.
  • Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy.
  • Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.
  • Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <=5 x ULN).
  • Dyspnea on exertion.
  • History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an left ventricular ejection fraction (LVEF) below 50%.
  • Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application. All methods based on hormonal contraception are not permitted.
  • Existing pregnancy or lactation (note on pregnancy test). A negative pregnancy test for women of childbearing potential has to be in place prior randomization (Note: A pregnancy test has to be done for patients who are not postmenopausal. Postmenopausal is defined as those not having a menstrual period for 12 months in a row).
  • Existing doubts on ability and willingness of the subject for cooperation.
  • Participation of the subject at a clinical study within the last 30 days.
  • Participation of the subject in the same clinical study at an earlier date.
  • Concomitant participation in another study than the one described here.
  • Abuse of drugs, alcohol, or pharmaceuticals.
  • Any condition, whether medical or non-medical, that may interfere, in the opinion of the investigator, with aim of this study.

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 (PELICAN Trial)

This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall survival, quality of life, time to treatment failure, and safety and tolerability will also be assessed.

Conditions
Breast Cancer
Being tested
Pegylated liposomal doxorubicin (SCH 200746), Capecitabine
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 doxorubicin (SCH 200746)Drug

    pegylated liposomal doxorubicin (50 mg/m^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity

  • CapecitabineDrug

    capecitabine (1250 mg/m^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity

Study groups in NCT00266799
Study groupRoleWhat they receive
Pegylated liposomal doxorubicinExperimentalNot described
Receives: Drug: Pegylated liposomal doxorubicin (SCH 200746)
CapecitabineActive comparatorNot described
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 (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)

    TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ \& >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.

    Measured: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death

Secondary outcomes (4)

  1. Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups

    Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ \& >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.

    Measured: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death

  2. Overall Survival Time in the PLD and Capecitabine Treatment Groups

    Survival time was defined as duration time from onset of treatment with the study drug until death.

    Measured: From Day 1 (Cycle 1) until Death

  3. Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups

    Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.

    Measured: From Day 1 (Cycle 1) until End of Treatment

  4. Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))

    QoL questionnaire was an EORTC QLQ-C30 \& SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle \& rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.

    Measured: From Screening to Day 1 of every Treatment Cycle up to 12 Cycles

Timeline

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

  1. First posted19 Dec 2005 (estimated)
  2. Study start13 Jan 2006
  3. Primary completion29 Sep 2010
  4. Study completion18 Oct 2010

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
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00266799
Sponsor's protocol ID
P04445
Status last verified
May 2017
First submitted
15 Dec 2005
Last updated
8 Jun 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

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 (SCH 200746) and Capecitabine in people with Breast Cancer, run by Merck Sharp & Dohme LLC.

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 13 inclusion and 26 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: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 16 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease 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 NCT00266799, 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 8 Jun 2017.

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