NCT00531973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

1.6 years

First QC Date

September 18, 2007

Last Update Submit

February 17, 2009

Conditions

Breast Cancer

Keywords

breast cancerechocardiographyneoplasia

Outcome Measures

Primary Outcomes (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.

    Up to 12 months

Secondary Outcomes (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.

    12 months

Study Arms (2)

A

EXPERIMENTAL

Liposomal doxorubicin

Drug: liposomal doxorubicin

B

ACTIVE COMPARATOR

epirubicin

Drug: epirubicin

Interventions

liposomal doxorubicinDRUG

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

A
epirubicinDRUG

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University

Rome, RM, 00168, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18572266DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

liposomal doxorubicinEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Marzia Lotrionte, MD

    marzial76@yahoo.it

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzia Lotrionte, MD

CONTACT

+39-3470717591marzial76@yahoo.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

December 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

IT(1)