Clinical trial NCT00531973: A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging
Official title: Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: breast cancer
echocardiography
neoplasia
Lead sponsor: Catholic University, Italy
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2007-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
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
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University
state: RM
Study officials:
affiliation: marzial76@yahoo.it
name: Marzia Lotrionte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lotrionte 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.