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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT00994968
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed invasive primary breast cancer
* Clinical (radiologic) stage II or III disease
* No T4d disease
* No inflammatory breast cancer
* ErbB2-negative disease OR patient cannot receive trastuzumab treatment
* ErbB2-positive disease defined as either immunohistochemistry 3+, or FISH- or CISH-positive; immunohistochemistry 2+ is to be determined according to FISH or CISH results
PATIENT CHARACTERISTICS:
* Mobile
* ECOG performance status 0-1
* Normal cardiac function (LVEF \> 50%)
* Hemoglobin ≥ 10.0 g/dL
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 10 x 10\^4/μL
* Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Total bilirubin ≤ 1.5 times ULN
* AST/ALT ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow tablet whole with water
* No prior motor or sensory neurotoxicity CTCAE ≥ grade 2
* No other serious disease or medical condition
* No uncontrolled or serious cardiovascular disease, including any of the following:
* Myocardial infarction within the past 6 months
* New York Heart Association class III or IV heart failure
* Uncontrolled angina pectoris
* Clinically significant pericardial disease
* Cardiac amyloidosis
* No history of symptomatic or therapy-requiring cardiac arrhythmia CTCAE grade 3 (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation)
* No asymptomatic sustained ventricular tachycardia
* History of atrial fibrillation or cardiac arrhythmia controlled by medication allowed
* No uncontrolled infection, unstable peptic ulcer, uncontrolled diabetes, or any other contraindication to corticosteroid administration
* No history of infection or any other serious medical event which may cause any functional injury in the affected patient and consequently, interfere with continuing the study treatment
* No history of hypersensitivity to taxanes, fluorouracil, or S-1
* No significant gastrointestinal malfunction that will affect S-1 absorption
* No history of other cancer within the past 5 years except properly treated carcinoma in situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
* No severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
* No psychological, social, family, or geographical condition, or difficult circumstance that would preclude follow-up or compliance with the protocol
PRIOR CONCURRENT THERAPY:
* No prior systemic treatment for this cancer (e.g., radiotherapy, chemotherapy, hormone therapy, or biological therapy)
* No prior preoperative topical treatments (e.g., incomplete surgery or radiotherapy) for this cancer
* No concurrent drug(s) that may potentially cause changes in the pharmacological activity of S-1 formulation, including any of the following:
* Allopurinol
* Phenytoin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00994968
Study Brief:
Protocol Section:
NCT00994968