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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00588003
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal patients, defined as one or more of the following criteria:
Documented history of bilateral oophorectomy, Aged 60 years or more,
Aged 45-59 years and satisfying one or more of the following criteria:
Amenorrhea for at least 12 months and intact uterus Amenorrhea for less than 12 months and follicle stimulating hormone (FSH) concentrations within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement therapy in the past.
* Clinically palpable or non-palpable T1c or greater, ER positive invasive breast cancer diagnosed by outside core biopsy.
* Outside diagnosis of invasive breast cancer confirmed at MSKCC
* Palpable or non-palpable breast mass \> 1cm highly suspicious for invasive breast cancer based on mammographic, ultrasound and/or physical examination findings and amenable to diagnostic core biopsy.
* Core biopsy diagnosis of ER positive invasive breast cancer performed at MSKCC
* Breast conserving surgery or mastectomy scheduled at MSKCC.
* Informed consent obtained.
Exclusion Criteria:
* Co-morbid conditions which would preclude use of aromatase inhibitors such as: previous hypersensitivity, severe hepatic insufficiency (SGOT or SGPT three times the upper limit of normal), severe renal insufficiency (creatinine clearance \<10ml/min).
Prior radiation therapy to chest wall / breast.
* Neoadjuvant chemotherapy
* Hormone replacement therapy, tamoxifen or raloxifene treatment within past 3 months
* ER negative breast cancer
* History of active malignancy within the previous 5 years (except for nonmelanoma skin cancer and breast cancer)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT00588003
Study Brief:
Protocol Section:
NCT00588003