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Caelyx Adjuvant in Elderly Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284336
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE December 23, 2005
First Posted Date  ICMJE January 31, 2006
Last Update Posted Date December 9, 2014
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx
  • The relation between cardiac SRI and classical ejection fraction measurement.
  • The relation between strain rate and blood markers such as troponin-I and BNP
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Caelyx Adjuvant in Elderly Breast Cancer
Official Title  ICMJE 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.
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Elderly
Intervention  ICMJE
  • Drug: Caelyx
    Other Name: liposomal doxorubicin
  • Drug: endoxan
    Other Name: cyclophosphamide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 30, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00284336
Other Study ID Numbers  ICMJE 2005-002995-13
S28720 UZ KUL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hans wildiers, MD PhD UH gasthuisberg Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP