Status:
COMPLETED
Caelyx Adjuvant in Elderly Breast Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Breast Cancer
Elderly
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
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 cyclophos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00284336
Start Date
January 1 2006
End Date
April 1 2007
Last Update
December 9 2014
Active Locations (2)
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1
UZ gent
Ghent, Belgium, 9000
2
UH gasthuisberg
Leuven, Belgium, 3000