A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging

Study Overview
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Brief Summary
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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
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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.

Official Title
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Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: liposomal doxorubicin
* Drug: epirubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Liposomal doxorubicin | Drug: liposomal doxorubicin<br>* 5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)<br>|
| Active Comparator: B<br>epirubicin | Drug: epirubicin<br>* 5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, echocardiography, neoplasia