Clinical trial NCT00284336: Caelyx Adjuvant in Elderly Breast Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Elderly
Keywords: breast cancer
elderly
adjuvant chemotherapy
Caelyx
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 16
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx
measure: The relation between cardiac SRI and classical ejection fraction measurement.
measure: The relation between strain rate and blood markers such as troponin-I and BNP
Secondary outcomes:
measure: To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ gent
city: Leuven
country: Belgium
facility: UH gasthuisberg
Study officials:
affiliation: UH gasthuisberg Leuven
name: hans wildiers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: