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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
liposomal doxorubicin
epirubicin
Sponsored by
Catholic University, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, echocardiography, neoplasia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Liposomal doxorubicin

epirubicin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2007
Last Updated
February 17, 2009
Sponsor
Catholic University, Italy
Collaborators
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00531973
Brief Title
A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging
Acronym
LITE
Official Title
Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University, Italy
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, echocardiography, neoplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Liposomal doxorubicin
Arm Title
B
Arm Type
Active Comparator
Arm Description
epirubicin
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Intervention Description
5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
Intervention Type
Drug
Intervention Name(s)
epirubicin
Intervention Description
5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marzia Lotrionte, MD
Phone
+39-3470717591
Email
marzial76@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzia Lotrionte, MD
Organizational Affiliation
marzial76@yahoo.it
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University
City
Rome
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marzia Lotrionte, MD
Phone
+39-3470717591
Email
marzial76@yahoo.it
First Name & Middle Initial & Last Name & Degree
Marzia Lotrionte, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18572266
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.
Results Reference
derived

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

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