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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT00211133
Eligibility Criteria:
Inclusion Criteria:
* Female patients \>= 18 years of age with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time
* Weight \> = 40 kg (88 lbs)
* Postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study
* Must have signed an informed consent
Exclusion Criteria:
* Clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease
* Receiving dose intensification chemotherapy for bone marrow or stem cell transplantation
* Cancer of the brain or brain/spinal cord disease
* Locally advanced or inflammatory breast cancer as the only symptom of breast cancer
* Active second primary cancer or documented history of other cancer within the last 3 years
* Anemia from a cause other than cancer or radiotherapy/chemotherapy
* History of stoke, clots in the lungs or legs or any other blood clotting disorders
* Uncontrolled high blood pressure
* Untreated folate or Vitamin B12 deficiency
* Treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks
* Known hypersensitivity to epoetin alfa or any of its components
* Pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00211133
Study Brief:
Protocol Section:
NCT00211133