Breast CancerPhase 4LITENCT00531973
A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging
A Phase 4 study testing liposomal doxorubicin and epirubicin in people with Breast Cancer, run by Catholic University, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- liposomal doxorubicin and epirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- LV systolic dysfunction (ejection fraction<50%)
- abnormal complete blood count
- pregnancy
- breast-feeding
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University
Rome, RM, 00168
Marzia Lotrionte, MD, +39-3470717591, marzial76@yahoo.it
Marzia Lotrionte, MD
About this study
Official title: Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
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.
Read the 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
- Being tested
- liposomal doxorubicin, epirubicin
- Keywords
- breast cancer, echocardiography, neoplasia
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal doxorubicinDrug
5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC)
epirubicinDrug
5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Liposomal doxorubicin Receives: Drug: liposomal doxorubicin |
| B | Active comparator | epirubicin Receives: Drug: epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Investigators
- Marzia Lotrionte, MD, Principal investigator, marzial76@yahoo.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531973
- Sponsor's protocol ID
- LITE Randomized Pilot Study
- Acronym
- LITE
- Status last verified
- Feb 2009
- First submitted
- 18 Sep 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18572266
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT00531973
- Acronym / sponsor ID
- LITE / LITE Randomized Pilot Study
- Conditions
- Breast Cancer
- Keywords
- breast cancer, echocardiography, neoplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Catholic University, ItalyUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: liposomal doxorubicinLiposomal doxorubicin |
| B | Active comparator | Drug: epirubicinepirubicin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- metastatic breast cancer
- past radiation therapy and chemotherapy
- hypertension and other cardiovascular risk factors
- prior valvular heart disease
- cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal doxorubicin5-fluorouracil (500 mg/m²) + pegylated liposomal doxorubicin (50 mg/m²) + cyclophosphamide (500 mg/m²) + adjuvant radiation therapy ± endocrinological therapy (FalipoC) | Drug | A |
| epirubicin5-fluorouracil (500 mg/m²) + epirubicin (90 mg/ m²) + cyclophosphamide (500 mg/ m²) + adjuvant radiation therapy ± endocrinological therapy (FEC90) | Drug | B |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Derived from this study: PubMed 18572266Lotrionte 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzia Lotrionte, MD principal investigator
marzial76@yahoo.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liposomal doxorubicin and epirubicin in people with Breast Cancer, run by Catholic University, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzia Lotrionte, MD (+39-3470717591, marzial76@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00531973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.