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

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ClinicalTrials.gov Identifier: NCT00005980
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):

July 5, 2000
January 27, 2003
July 18, 2012
April 2000
July 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005980 on ClinicalTrials.gov Archive Site
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Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer

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.


  • 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.

Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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July 2002   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Greece,   Israel,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
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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
European Organisation for Research and Treatment of Cancer - EORTC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP