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Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer

Elderly individuals make up a large part of the breast cancer population. When treated with
chemotherapy for metastatic disease they derive similar benefits to their younger
counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy
with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin
improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity
and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination
with cyclophosphamide as first-line therapy for metastatic breast cancer

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic breast adenocarcinoma

- No more than one prior therapy regimen (other than hormonal therapy) for metastatic
breast cancer is acceptable.

- Measurable disease as defined by the presence of at least one measurable lesion
(except bone metastases, ascites or pleural effusions)

- Performance status (WHO) 0-2

- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT
<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or
<5 times the upper normal limit in the presence of liver metastases)

- Adequate renal function (serum creatinine <1.5 times the upper normal limit)

- Adequate cardiac function (LVEF within normal limits)

- Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109

- No radiation of measurable disease (except brain metastases)

- No progressive brain metastases according to clinical or radiological criteria

- No brain metastases without prior radiation therapy

- Written informed consent

Exclusion Criteria:

- Active infection

- History of significant cardiac disease (unstable angina, congestive heart failure,
myocardial infarction within the previous 6 months, ventricular arrhythmias)

- Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during
the previous 12 months period

- Other invasive malignancy except non-melanoma skin cancer

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

Objective responses confirmed by CT or MRI every 3 months

Safety Issue:


Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete


Greece: National Organization of Medicines

Study ID:




Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Elderly
  • Chemotherapy
  • Cardiotoxicity
  • Breast Neoplasms