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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT00328432
Eligibility Criteria:
Inclusion Criteria:
* women with a recent diagnosis of T1 or T2 non-invasive breast cancer by large core needle or excisional biopsy
* confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments
* reexcision planned within 10 days to 6 weeks from study start
* if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
Exclusion Criteria:
* no hormone replacement therapy within the 90 days prior to biopsy
* if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
* no evidence of metastatic malignancy of any kind
* no history of asthma, allergy ASA, NSAIDS, celecoxib or other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study.
* no celecoxib or rofecoxib use within one month of biopsy
* no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
* no current anticoagulants
* no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
* no aromatase inhibitor in the six months prior to participation
* no concomitant lithium
* no known significant bleeding disorder
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00328432
Study Brief:
Protocol Section:
NCT00328432