A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, echocardiography, neoplasia
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: liposomal doxorubicin Type: Drug
Name: epirubicin Type: Drug
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Catholic University
Rome, RM, Italy
Status: Recruiting
Contact: Marzia Lotrionte, MD - +39-3470717591 - marzial76@yahoo.it
Start Date
January 2007
Completion Date
December 2009
Sponsors
Catholic University, Italy
Source
Catholic University, Italy
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page