Caelyx(R) in Breast Cancer in the Elderly. Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer.
65 Years
N/A
Female
Breast Neoplasms
Trial Information
Caelyx(R) in Breast Cancer in the Elderly. Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer.
Inclusion Criteria:
- Patients meeting the following criteria will be eligible for enrollment.
- Female patients with histologic or cytologic diagnosis of breast cancer that is
locally advanced or metastatic, and not amenable to surgery.
- Age >= 65 years.
- World Health Organization (WHO) Performance Status 0 - 2
- Measurable disease in accordance with Response Evaluation Criteria in Solid
Tumors (RECIST) criteria. Patients with bone metastasis can also be included but
will be evaluated according to WHO criteria. Patients with non-measurable
disease can also be included.
- Left ventricular ejection fraction (LVEF) >= 50% verified by ultrasound
cardiography (UCG); no clinical signs of heart disease.
- Normal organ function, except due to disease involvement, however maximum
deviation:
- S-creatinine <= 1.5 x upper normal limit;
- Bilirubin <= 2 x upper normal limit;
- Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) <=
3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT <= 5
x upper normal limit.
- Adequate bone marrow function, ie:
- Platelets >= 100 x 10^9/L;
- Neutrophils >= 1.5 x 10^9/L;
- White Blood Cell (WBC) >= 3.0 x 10^9/L;
- Hemoglobin > 90 g/L.
- Life expectancy >= 12 weeks.
- Patients having received oral and written information and having provided
written informed consent.
Exclusion Criteria:
- Patients will not be enrolled if any of the following conditions apply.
- Previous chemotherapy for metastatic disease. (The patient may have received
previous endocrine therapy or single-drug Herceptin. Intrapleural or
intrapericardial Novantrone is allowed.)
- Recurrence <= 12 months after adjuvant anthracycline-containing treatment and/or
prior doxorubicin > 300 mg/m^2 or epirubicin > 540 mg/m^2.
- Myocardial infarction within 6 months of planned inclusion.
- Symptomatic brain metastases.
- Human Epidermal growth factor Receptor 2 (HER-2) positivity eligible for
treatment with trastuzumab, or estrogen receptor (ER) positivity eligible for
hormonal therapy.
- Allergy to anthracyclines.
- Uncontrolled infection.
- Other not radically treated malignancy.
- Other disease or condition contraindicating treatment or not allowing follow-up.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors {RECIST} or World Health Organization {WHO} Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).
Outcome Description:
Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.
Outcome Time Frame:
Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Safety Issue:
No
Authority:
Sweden: Medical Products Agency
Study ID:
P05059
NCT ID:
NCT00604968
Start Date:
February 2007
Completion Date:
October 2009
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
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