Breast Cancer
Conditions
Keywords
breast cancer, echocardiography, neoplasia
Brief 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.
Interventions
DRUGliposomal doxorubicin
5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
DRUGepirubicin
5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
Sponsors
Cephalon
Catholic University, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | Up to 12 months |
Secondary
| 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. | 12 months |
Countries
Italy
Contacts
Primary ContactMarzia Lotrionte, MD
Outcome results
None listed