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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Catholic University, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cephalon
Information provided by:
Catholic University, Italy
ClinicalTrials.gov Identifier:
NCT00531973
First received: September 18, 2007
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Breast Cancer
Drug: liposomal doxorubicin
Drug: epirubicin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Catholic University, Italy:

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. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531973

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

No publications provided by Catholic University, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marzia Lotrionte, Consultant, Catholic University
ClinicalTrials.gov Identifier: NCT00531973     History of Changes
Other Study ID Numbers: LITE Randomized Pilot Study
Study First Received: September 18, 2007
Last Updated: February 17, 2009
Health Authority: Italy: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014