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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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)



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 19, 2007    Key Record Dates
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