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

Phase 4
18 Years
65 Years
Open (Enrolling)
Breast Cancer

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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:


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:


Principal Investigator

Marzia Lotrionte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:


Italy: Ministry of Health

Study ID:

LITE Randomized Pilot Study



Start Date:

January 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • echocardiography
  • neoplasia
  • Breast Neoplasms