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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00665457
Eligibility Criteria:
Inclusion Criteria:
* Pathologic evidence of invasive breast cancer
* Stage II-III disease
* Resectable disease
* Must have a primary tumor estimated by mammogram, ultrasound or palpation to be ≥ 3 cm and/or palpable axillary nodes \> 1 cm for whom neoadjuvant chemotherapy is appropriate
* ECOG performance status 0-1
* Absolute granulocyte count \> 2,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum bilirubin \< 1.5 times upper limit of normal (ULN)
* Serum creatinine \< 1.5 times ULN
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors
Exclusion Criteria:
* Not pregnant or nursing/negative pregnancy test
* No allergies to sulfa medication, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
* No uncontrolled concurrent illness that might jeopardize the patient's ability to receive the chemotherapy program outlined in this protocol, including any of the following:
* Active infection requiring intravenous antibiotics
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Serious, uncontrolled cardiac arrhythmia
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
* No prior chemotherapy or radiation therapy for ipsilateral breast cancer
* No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections
* No concurrent participation in another therapeutic clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
120 Years
Study:
NCT00665457
Study Brief:
Protocol Section:
NCT00665457