A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging (LITE)
February 17, 2009 updated by: Catholic University, Italy
Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
The randomized LITE study will compare liposomal doxorubin versus standard epirubicin in the treatment of female breast cancer.
In order to detect as early as possible post-chemotherapy cardiotoxicity, tissue Doppler imaging parameters elicited at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The randomized LITE study will compare liposomal doxorubin versus standard epirubicin within a comprehensive adjuvant or neo-adjuvant chemotherapy regimen in women undergoing treatment for breast cancer.
The study will enrol a total of 80 patients, randomized 1:1 to liposomal doxorubin vs epirubicin.
Standard and tissue Doppler imaging parameters will be appraised at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points.
In addition, other efficacy and safety end-points will be appraised, including disease free progression.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RM
-
Rome, RM, Italy, 00168
- Recruiting
- Catholic University
-
Contact:
- Marzia Lotrionte, MD
- Phone Number: +39-3470717591
- Email: marzial76@yahoo.it
-
Principal Investigator:
- Marzia Lotrionte, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women with age ≥18 and ≤65 years
- histological and/or cytological diagnosis of clinically non-metastatic breast cancer (c/pTall, c/pNall, cM0)
- indication for integrated treatment with surgical intervention associated with adjuvant or neo-adjuvant chemotherapy, endocrinological and radiation therapy, including adjuvant or neo-adjuvant chemotherapy with anthracycline
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2
- normal kidney, hepatic and hematological function
- normal LV ejection fraction at baseline (≥50%)
- negative pregnancy test in fecund women
Exclusion Criteria:
- metastatic breast cancer
- past radiation therapy and chemotherapy
- hypertension and other cardiovascular risk factors
- prior valvular heart disease
- cardiomyopathy
- chronic or acute congestive heart failure
- LV systolic dysfunction (ejection fraction<50%)
- abnormal complete blood count
- pregnancy
- breast-feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Liposomal doxorubicin
|
5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
|
|
Active Comparator: B
epirubicin
|
5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comparison of changes of PW-TDI systolic function parameters. The co-primary end-point ill be the comparison of changes from baseline to 12-month follow-up of PW-TDI diastolic function parameters.
Time Frame: Up to 12 months
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes of standard 2-dimensional echocardiography parameters, including LV ejection fraction, peak values of biochemical markers of cardiac damage and heart failure, ie cardiac troponin T and BNP.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marzia Lotrionte, MD, marzial76@yahoo.it
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Anticipated)
August 1, 2008
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 18, 2007
First Posted (Estimate)
September 19, 2007
Study Record Updates
Last Update Posted (Estimate)
February 18, 2009
Last Update Submitted That Met QC Criteria
February 17, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LITE Randomized Pilot Study
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