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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.


Phase 2
65 Years
N/A
Not Enrolling
Female
Breast Cancer, Elderly

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Trial Information

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.


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 ┬Ámol/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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx

Principal Investigator

hans wildiers, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UH gasthuisberg Leuven

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

2005-002995-13

NCT ID:

NCT00284336

Start Date:

January 2006

Completion Date:

April 2007

Related Keywords:

  • Breast Cancer
  • Elderly
  • breast cancer
  • elderly
  • adjuvant chemotherapy
  • Caelyx
  • Breast Neoplasms

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