Clinical trial · Interventional
A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging
Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
NCT00531973CI-TRIAL-00002067LITEunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin | Drug | Epirubicin | ALIAS |
| liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Liposomal doxorubicin
- interventionNames
- Drug: liposomal doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- epirubicin
- interventionNames
- Drug: epirubicin
Primary outcomes (1)
- 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.
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLotrionte M, Palazzoni G, Natali R, Comerci G, Abbate A, Di Persio S, Biondi-Zoccai GG. Appraising cardiotoxicity associated with liposomal doxorubicin by means of tissue Doppler echocardiography end-points: rationale and design of the LITE (Liposomal doxorubicin-Investigational chemotherapy-Tissue Doppler imaging Evaluation) randomized pilot study. Int J Cardiol. 2009 Jun 12;135(1):72-7. doi: 10.1016/j.ijcard.2008.03.036. Epub 2008 Jun 24. PMID 18572266