Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT00604968
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT00604968
Study Brief:
Protocol Section:
NCT00604968