Myocet Plus Endoxan for Older Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01120171
First received: May 5, 2010
Last updated: June 21, 2014
Last verified: June 2014

May 5, 2010
June 21, 2014
September 2009
December 2014   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01120171 on ClinicalTrials.gov Archive Site
  • Toxicity profile [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Myocet Plus Endoxan for Older Patients With Breast Cancer
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Cyclophosphamide

    Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

    Therapy will continue until maximum response,or unacceptable toxicity.

    Other Name: Endoxan
  • Drug: Liposomal-encapsulated doxorubicin

    Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.

    Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

    Therapy will continue until maximum response or unacceptable toxicity.

    Other Name: Myocet
Experimental: 1
Cyclofosfamide/Liposomal-encapsulated doxorubicin
Interventions:
  • Drug: Cyclophosphamide
  • Drug: Liposomal-encapsulated doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
December 2014
December 2014   (final data collection date for primary outcome measure)

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 /L)
  • 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
Female
18 Years and older
No
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Greece
 
NCT01120171
CT/08.32
No
Hellenic Oncology Research Group
Hellenic Oncology Research Group
Not Provided
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
Hellenic Oncology Research Group
June 2014

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