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

• ClinicalTrials.gov Identifier: NCT00531973
• Recruitment Status: Unknown
• First Posted: September 19, 2007
• Last Update Posted: February 18, 2009
• Sponsor: Catholic University, Italy
• Collaborator: Cephalon
• Information provided by: Catholic University, Italy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: liposomal doxorubicin; Drug: epirubicin	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
• Study Start Date: January 2007
• Estimated Primary Completion Date: August 2008
• Estimated Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Liposomal doxorubicin	Drug: liposomal doxorubicin; 5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
Active Comparator: B; epirubicin	Drug: epirubicin; 5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :

1. 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. [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Marzia Lotrionte, MD; +39-3470717591; marzial76@yahoo.it

Locations

Italy

Catholic University; Recruiting

Rome, RM, Italy, 00168

Contact: Marzia Lotrionte, MD +39-3470717591 marzial76@yahoo.it

Principal Investigator: Marzia Lotrionte, MD

Sponsors and Collaborators

Catholic University, Italy

Cephalon

Investigators

• Principal Investigator: Marzia Lotrionte, MD; marzial76@yahoo.it

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Marzia Lotrionte, Consultant, Catholic University
• ClinicalTrials.gov Identifier: NCT00531973
• Other Study ID Numbers: LITE Randomized Pilot Study
• First Posted: September 19, 2007
• Last Update Posted: February 18, 2009
• Last Verified: February 2009

Keywords provided by Catholic University, Italy:

breast cancer; echocardiography; neoplasia

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Doxorubicin; Liposomal doxorubicin; Epirubicin; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action