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Trial #NCT01120171
Breast Cancer Clinical Trials

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
Study ID: CT/08.32; Source: Hellenic Oncology Research Group
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country Greece
Study type Interventional
Enrollment 46
Start date September 2009
Completion date December 2014
Phase Phase 2
Sponsor Hellenic Oncology Research Group
Summary:
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
Description:
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
Eligibility:
Gender: Female
Age: 18 Years - N/A
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
Outcome:
Primary outcome
  • Overall Response Rate
    Time frame: Objective responses confirmed by CT or MRI every 3 months
Secondary outcome
  • Overall Survival
    Time frame: 1 year
  • Time to Tumor Progression
    Time frame: 1-year
  • Toxicity profile
    Time frame: Toxicity assessment every month
Contacts:
  • Dimitris Mavrudis, MD; University Hospital of Crete (Principal Investigator)
  • Dora Hatzidaki;
    Phone: +302810392570
  • Eva Maragkoudaki;
    Phone: +302810392857
Location Country Status
University General Hospital of Alexandroupolis Alexandroupolis, Greece Recruiting
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Athens, Greece Recruiting
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Athens, Greece Recruiting
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Athens, Greece Recruiting
401 Military Hospital of Athens Athens, Greece Recruiting
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology Athens, Greece Recruiting
Air Forces Military Hospital of Athens Athens, Greece Recruiting
University Hospital of Crete Heraklion, Greece Recruiting
State General Hospital of Larissa, Dep of Medical Oncology Larissa, Greece Recruiting
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Thessaloniki, Greece Recruiting
"Diabalkaniko" hospital, Thessaloniki Thessaloniki, Greece Recruiting
Sponsors:
  • Hellenic Oncology Research Group - (Lead Sponsor)

Related trials: Terms
  • Chemotherapy
  • Breast cancer
  • Cardiotoxicity
  • Elderly
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