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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00001193
Eligibility Criteria:
Patients must have a histologically documented diagnosis of mammary carcinoma and evaluable disease in the breast.
Diagnostic tissue must be reviewed at NIH.
All ICB patients must meet Haagensen's clinical criteria of ICB.
Patients with metastatic breast cancer must have evaluable disease.
There must be no history of prior cytotoxic therapy.
There must be no history of previous malignancy except for cured nonmelanoma skin cancer and cervical carcinoma in situ.
Performance status (Karnofsky scale) must be greater than 30 for patients with metastatic breast cancer.
Staging workup must be negative for distant metastases in Stage III patients.
WBC count greater than 4000 per mm(3) and platelet count greater than 100,000 per mm(3).
Normal hepatic and renal function, unless due to tumor involvement.
Patients must be willing to give informed consent and be geographically accessible for follow up.
No history of other malignant neoplasms except for curatively treated nonmelanoma skin cancer or surgically cured carcinoma of the cervix in situ.
Patients must not be poor medical or psychiatric risks because of non-malignant systemic disease which would preclude them being subjected to any of the treatments in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001193
Study Brief:
Protocol Section:
NCT00001193