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

NCT ID: NCT00531973

Last Updated: 2009-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Liposomal doxorubicin

Group Type: EXPERIMENTAL

liposomal doxorubicin

Intervention Type: DRUG

5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)

B

epirubicin

Group Type: ACTIVE_COMPARATOR

epirubicin

Intervention Type: DRUG

5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)

Interventions

liposomal doxorubicin

5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)

Intervention Type: DRUG

epirubicin

5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: collaborator

Catholic University, Italy

OTHER

Sponsor Role: lead

Responsible Party

Catholic University

Principal Investigators

Marzia Lotrionte, MD

Role: PRINCIPAL_INVESTIGATOR

marzial76@yahoo.it

Locations

Catholic University

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marzia Lotrionte, MD

Role: CONTACT

marzial76@yahoo.it

+39-3470717591

Facility Contacts

Marzia Lotrionte, MD

Role: primary

marzial76@yahoo.it

+39-3470717591

References

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.

Reference Type: DERIVED

PMID: 18572266 (View on PubMed)

Other Identifiers

LITE Randomized Pilot Study

Identifier Type: -

Identifier Source: org_study_id