Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
18 Years
65 Years
Female
Breast Cancer
Trial Information
Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
Up to 12 months
Safety Issue:
No
Principal Investigator
Marzia Lotrionte, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
marzial76@yahoo.it
Authority:
Italy: Ministry of Health
Study ID:
LITE Randomized Pilot Study
NCT ID:
NCT00531973
Start Date:
January 2007
Completion Date:
December 2009
Related Keywords:
- Breast Cancer
- breast cancer
- echocardiography
- neoplasia
- Breast Neoplasms
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