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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02450058
Eligibility Criteria:
Inclusion Criteria:
* Women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
* Lymph node-positive disease with less than 10 involved axillary lymph nodes
* Surgery performed not more than 5 weeks before randomization
* ECOG performance status 0
* Absolute neutrophil count ≥ 2,000/mm³
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* Postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
* Written informed consent
Exclusion Criteria:
* Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
* Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
* Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
* Pregnant or nursing
* Other serious medical illness requiring medication, uncontrolled infections
* Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
* Recent myocardial infarction, congestive heart failure, or serious arrhythmia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02450058
Study Brief:
Protocol Section:
NCT02450058