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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00148720
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation of primary invasive breast cancer
* Stage I-III operable breast cancer.
* Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
* Women greater than 18 years of age
* ECOG performance status 0-1
* WBC \> 4000/mm3
* Platelet count \> 100,000/mm3
* SGOT \< 2x ULN
* Calculated creatinine clearance \> 50ml/min
Exclusion Criteria:
* Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
* Pregnant or breast-feeding women
* Inflammatory breast cancer
* HER2 positive disease
* History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency
* Uncontrolled intercurrent illness
* Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
* Excisional biopsy performed prior to enrollment
* Uncontrolled coagulopathy
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00148720
Study Brief:
Protocol Section:
NCT00148720