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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT01199432
Eligibility Criteria:
Inclusion Criteria:
* Female patients, age ≦ 65 years old
* Histologically or cytologically confirmed primary breast cancer by core biopsy
* Disease stage appropriate for neoadjuvant chemotherapy (T2～T3，N0～2，M0)
* No previous treatment for breast cancer
* No history of other malignancies
* No currently uncontrolled diseased (e.g., ongoing cardiac dysrhythmias, unstable diabetes) or active infection
* No history of other malignancies
* No currently uncontrolled diseased or active infection
* Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
* Adequate cardiovascular function reserve without a myocardial infarction within the past six month
* Adequate hematologic function with:
1. Absolute neutrophil count (ANC) ≥ 1500/mm3
2. Platelets ≥ 100,000/ mm3
3. Hemoglobin ≥ 10 g/dL
* Adequate hepatic and renal function with:
1. Serum bilirubin ≤ 1.5×UNL
2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
3. Serum creatinine ≤ 1.7 mg/dl
* Knowledge of the investigational nature of the study and Ability to give informed consent
* Ability and willingness to comply with study procedures
Exclusion Criteria:
* Known or suspected distant metastases
* Concurrent malignancy or history of other malignancy
* Uncontrolled diseases or active infection
* Hepatic or renal dysfunction as detailed above
* Geographical, social, or psychological problems that would compromise study compliance
* Known or suspected hypersensitivity to cyclophosphamide, epirubicin and fluorouracil
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01199432
Study Brief:
Protocol Section:
NCT01199432