Back to resultsMyocet Plus Endoxan for Older Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Cyclophosphamide
Liposomal-encapsulated doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Elderly, Chemotherapy, Cardiotoxicity
Eligibility Criteria
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
Sites / Locations
- University General Hospital of Alexandroupolis
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
- "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
- 401 Military Hospital of Athens
- Air Forces Military Hospital of Athens
- University Hospital of Crete
- State General Hospital of Larissa, Dep of Medical Oncology
- "Diabalkaniko" hospital, Thessaloniki
- : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cyclofosfamide/Liposomal-encapsulated doxorubicin
Outcomes
Primary Outcome Measures
Overall Response Rate
Secondary Outcome Measures
Toxicity profile
Time to Tumor Progression
Overall Survival
Full Information
NCT ID
NCT01120171
First Posted
May 5, 2010
Last Updated
October 6, 2015
Sponsor
Hellenic Oncology Research Group
1. Study Identification
Unique Protocol Identification Number
NCT01120171
Brief Title
Myocet Plus Endoxan for Older Patients With Breast Cancer
Official Title
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to poor accrual
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Elderly, Chemotherapy, Cardiotoxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cyclofosfamide/Liposomal-encapsulated doxorubicin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal-encapsulated doxorubicin
Other Intervention Name(s)
Myocet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
Objective responses confirmed by CT or MRI every 3 months
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
Toxicity assessment every month
Title
Time to Tumor Progression
Time Frame
1-year
Title
Overall Survival
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavrudis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Crete
City
Heraklion
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
"Diabalkaniko" hospital, Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
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Myocet Plus Endoxan for Older Patients With Breast Cancer
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