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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT00429104
Eligibility Criteria:
Inclusion Criteria:
1. Histological confirmation of invasive carcinoma of the breast.
2. HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).
3. Stage IV breast cancer with measurable disease.
4. Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.
5. Zubrod performance status 0 or 1.
6. Adequate hematological parameters (White Blood cells-WBC \> 3,000/mm3, platelet count \> 100,000/mm3), adequate renal function (serum creatinine \< 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) \< 3 x normal).
Exclusion Criteria:
1. Active Brain metastasis.
2. No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).
3. More than 2 Herceptin containing regimens in metastatic breast cancer.
4. Known history of HIV positive.
5. Chronic active hepatitis or cirrhosis.
6. Symptomatic pulmonary disease.
7. Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00429104
Study Brief:
Protocol Section:
NCT00429104