Caelyx Adjuvant in Elderly Breast Cancer

NCT00284336 | Completed Phase 2

• 2 other identifiers: 2005-002995-13S28720 UZ KUL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Elderly

Keywords

breast cancer; elderly; adjuvant chemotherapy; Caelyx

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.

Interventions

Caelyx DRUG

Also known as: liposomal doxorubicin

endoxan DRUG

Also known as: cyclophosphamide

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

UZ gent

Ghent, 9000, Belgium

Location

UH gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• hans wildiers, MD PhD

  UH gasthuisberg Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct head of clinic

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: January 31, 2006
• Study Start: January 1, 2006
• Study Completion: April 1, 2007
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

BE (2)