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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT00826267
Eligibility Criteria:
Inclusion criteria:
1. Female, age 18 years or older.
2. Histologically proven breast cancer who have not received any prior therapy.
3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
4. HER2-positive.
Exclusion criteria:
1. Absolute neutrophil count (ANC) less than 1500/mm3.
2. Platelet count less than 100 000/ mm3.
3. Hemoglobin level less than 9.0 g/dl.
4. Bilirubin greater than 1.5 mg/dI.
5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
6. Serum creatinine greater than 1.5 times of the upper normal limit.
7. Significant or recent acute gastrointestinal disorders with diarrhea
8. Pregnancy or breast-feeding.
9. Organ system dysfunction including cardiac (LVEF \< 50%).
10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
11. Other malignancies diagnosed within the past five years.
12. Serious active infection. HIV, active hepatitis B or C.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00826267
Study Brief:
Protocol Section:
NCT00826267