Caelyx Adjuvant in Elderly Breast Cancer
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ClinicalTrials.gov Identifier: NCT00284336 |
Recruitment Status :
Completed
First Posted : January 31, 2006
Last Update Posted : December 9, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Elderly | Drug: Caelyx Drug: endoxan | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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. |
Study Start Date : | January 2006 |
Study Completion Date : | April 2007 |

- Drug: Caelyx
Other Name: liposomal doxorubicin
- Drug: endoxan
Other Name: cyclophosphamide
- 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
- To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284336
Belgium | |
UZ gent | |
Gent, Belgium, 9000 | |
UH gasthuisberg | |
Leuven, Belgium, 3000 |
Principal Investigator: | hans wildiers, MD PhD | UH gasthuisberg Leuven |
Responsible Party: | prof. dr. Hans Wildiers, adjunct head of clinic, Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00284336 |
Other Study ID Numbers: |
2005-002995-13 S28720 UZ KUL |
First Posted: | January 31, 2006 Key Record Dates |
Last Update Posted: | December 9, 2014 |
Last Verified: | December 2014 |
breast cancer elderly adjuvant chemotherapy Caelyx |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Doxorubicin Liposomal doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |