AzTrials
AzTrials

Breast CancerPhase 2NCT00284336

Caelyx Adjuvant in Elderly Breast Cancer

A Phase 2 study testing Caelyx and endoxan in people with Breast Cancer and Elderly, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open label Phase II study in elderly patients (65y or older) with early breast cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin (Caelyx) and cyclophosphamide (endoxan) will be used. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Cancer, Elderly
What is being tested?
Caelyx and endoxan
How many people
16 participants
Where
2 sitesBelgium
Study dates
Jan 2006to Apr 2007
Phase
Phase 2
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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria).
  • Age > 65 years
  • Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
  • Performance status 0 to 2 (WHO scale)
  • The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
  • Adequate organ function (as defined by neutrophils > 1.5 x109/L, Platelets > 100 x 109/L, Hemoglobin > 10 g/dl, total bilirubin > 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL, alkaline phosphatase > 2.5 UNL, creatinine > 1.5 mg/dl (150 µmol/L)
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  • Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
  • Patients must be accessible for treatment and follow-up.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

  • Metastatic disease (M1)
  • Prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
  • Prior radiation therapy for breast cancer.
  • Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria.
  • Serious illness or medical condition:
  • Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias
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  • History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
  • Active uncontrolled infection
  • Active peptic ulcer, unstable diabetes.
  • Past (less than 5 years) or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix.
  • Concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry
  • Concurrent treatment with other experimental drugs. No participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
  • Concurrent treatment with any other anti-cancer therapy.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • UZ gent

    Ghent, 9000

  • UH gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: An Open Label Phase II Trial to Investigate the Cardiac Effects of Pegylated Liposomal Doxorubicine (Caelyx) in Elderly Breast Cancer Patients With New Imaging and Biochemical Techniques.

This is an open label Phase II study in elderly patients (65y or older) with early breast cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin (Caelyx) and cyclophosphamide (endoxan) will be used. The aim is to study the cardiac effects of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical echocardiography, and special blood tests measuring troponin I and BNP.

Being tested
Caelyx, endoxan
Keywords
breast cancer, elderly, adjuvant chemotherapy, Caelyx
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaelyxDrug

    Also called liposomal doxorubicin

  • endoxanDrug

    Also called cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx

  2. The relation between cardiac SRI and classical ejection fraction measurement.

  3. The relation between strain rate and blood markers such as troponin-I and BNP

Secondary outcomes (1)

  1. To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Study completionApr 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00284336
Sponsor's protocol ID
2005-002995-13
Other IDs
S28720 UZ KUL, 2005
Status last verified
Dec 2014
First submitted
23 Dec 2005
Last updated
9 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caelyx and endoxan in people with Breast Cancer and Elderly, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

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 10 inclusion and 13 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: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx. The study lists 3 primary outcomes in all. 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 NCT00284336.

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 9 Dec 2014.

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