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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT00001493
Eligibility Criteria:
Patients with stage IV breast cancer are eligible provided they have not received chemotherapy for metastatic disease. Patients with stage IV breast cancer who have received prior adjuvant chemotherapy are eligible.
Patients who have received prior doxorubicin therapy will be eligible. Patients who have received a lifetime doxorubicin dose greater than 550 mg/m(2) or who have an initial MUGA ejection fraction of between 40% and less than 50% will receive vinblastine instead of doxorubicin.
Age greater than or equal to 18.
ECOG performance status of 0-2.
Adequate cardiac function as defined by an LVEF greater than or equal to 40% on MUGA scan or an echocardiogram which demonstrates normal LV function.
Adequate hematologic function with neutrophils greater than 1,200/mm(3) and platelets less than 100,000/mm(3) unless due to metastatic bone marrow involvement.
Adequate renal and hepatic function with creatinine less than 2.0 mg/dl, bilirubin less than 1.8 mg/dl, and hepatic transaminases less than 2 times the upper limit of normal unless due to metastatic cancer.
A 12-24 hour creatinine clearance greater than 50 ml/min.
No prior chemotherapy or radiation therapy within 3 weeks before starting protocol therapy and patients must have recovered from any toxicity from any prior therapy.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001493
Study Brief:
Protocol Section:
NCT00001493