Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005980
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: pegylated liposomal doxorubicin hydrochloride Phase 2

Detailed Description:


  • Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.
  • Assess the side effects of these treatment regimens in this patient population.
  • Determine the duration of response in these patients treated with these regimens.
  • Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
  • Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
Study Start Date : April 2000
Actual Primary Completion Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically proven progressive or recurrent metastatic breast cancer
  • Bidimensionally measurable disease with at least one target lesion

    • If previously irradiated lesions:

      • No preirradiated only lesions
      • Clear progression prior to study
      • New lesions in a previously irradiated region allowed
  • Refusal of or medical contraindication to standard anthracycline containing regimen
  • Hormone receptor status:

    • Not specified



  • Any age


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • Transaminases less than 2 times upper limit of normal


  • Creatinine normal


  • Left ventricular ejection fraction normal by echocardiography or MUGA scan
  • No significant cardiac history including:

    • Clinically significant atrial or ventricular arrhythmias requiring treatment
    • Medically controlled congestive heart failure
    • Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
    • Clinically significant valvular disease


  • No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2
  • No greater than one regimen of prior chemotherapy for metastatic disease
  • No prior anthracyclines for metastatic disease
  • No other concurrent cytotoxic therapy

Endocrine therapy:

  • No concurrent hormonal therapy
  • At least 4 weeks since prior progestins, estrogens, or androgens


  • See Disease Characteristics
  • Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field


  • Not specified


  • Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
  • No other concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005980

Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, Austria, A-1100
Institut Bergonie
Bordeaux, France, 33076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Institut Curie - Section Medicale
Paris, France, 75248
Centre Henri Becquerel
Rouen, France, 76038
University of Ioannina
Ioannina, Greece, GR-45110
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel, 49100
Mario Negri Institute for Pharmacological Research
Milano (Milan), Italy, 20157
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Clinique De Genolier
Genolier, Switzerland, Ch-1272
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Robert E. Coleman, MD, FRCP Cancer Research Centre at Weston Park Hospital
Study Chair: Maurizio D'Incalci, MD Mario Negri Institute for Pharmacological Research
Study Chair: Christian Dittrich, MD Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

Publications of Results:
Other Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00005980     History of Changes
Other Study ID Numbers: EORTC-10993-16998
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action