Caelyx Adjuvant in Elderly Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00284336
First received: December 23, 2005
Last updated: February 20, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Elderly
Drug: Caelyx
Drug: endoxan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.

Estimated Enrollment: 16
Study Start Date: January 2006
Estimated Study Completion Date: April 2007
Intervention Details:
    Drug: Caelyx
    Other Name: liposomal doxorubicin
    Drug: endoxan
    Other Name: cyclophosphamide
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284336

Locations
Belgium
UZ gent
Gent, Belgium, 9000
UH gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: hans wildiers, MD PhD UH gasthuisberg Leuven
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284336     History of Changes
Other Study ID Numbers: 2005-002995-13, S28720 UZ KUL
Study First Received: December 23, 2005
Last Updated: February 20, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Gasthuisberg:
breast cancer
elderly
adjuvant chemotherapy
Caelyx

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on April 21, 2014