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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT00001504
Eligibility Criteria:
DISEASE CHARACTERISTICS:
All patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.
Patients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.
Patients may have stage IV with ER/PR-positive or -negative tumor.
No CNS metastases, pseudotumor cereri, or seizures.
PRIOR/CONCURRENT THERAPY:
Patients who have ecovered from the toxic effects of prior therapy will be eligible.
Patients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Sex: Men and women.
Menopausal status: Any status.
Patients must have a performance status of ECOG 0-2.
Patients must have Hematopoietic criteria of:
ANC at least 1,500/mm(3).
Platelet count at least 90,000/mm(3).
Patients must have Hepatic criteria of:
In the absence of tumor involvement:
Bilirubin no greater than twice normal;
SGOT no greater than twice normal;
Alkaline phosphate no greater than twice normal;
Fasting triglycerides less than 3 times normal.
Patients must have Renal criteria of:
Serum creatinine no greater than 1.5 mg/dL OR;
Creatinine clearance at least 60 mL/min.
Other:
No allergy to study medications.
No nonmalignant systemic disease that would preclude therapy.
No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.
Pregnant women will be excluded.
Negative pregnancy test required within 7 days prior to entry.
Adequate contraception required for 4 weeks prior to, during, and for 1 year after study.
Patients must give informed consent.
Patients who are poor medical or psychiatric risks will be eligible.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001504
Study Brief:
Protocol Section:
NCT00001504