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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT00004205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed resectable adenocarcinoma of the breast
* pT1, pT2, pT3, or minimal dermal involvement on pathology only
* pN0, pN1, pN2, or M0
* Negative nodal status
* At least 8 nodes are negative
* Unknown nodal status
* Less than 8 nodes examined and no pathological finding
* Positive nodal status
* Any positive finding independent of the number of nodes examined
* Negative sentinel node or no prior nodal dissection allowed if all other criteria met
* Must have had total mastectomy, lumpectomy, or quadrantectomy
* Should have prior chest wall radiotherapy after segmental mastectomy or histopathologic T4 dermal involvement
* Stage I, II, or IIIa allowed if the tumor is completely removed macroscopically and margins of the resected tumor are microscopically free of tumor
* Must undergo chest wall radiotherapy or second resection if microscopic disease at the mastectomy margins
* No bilateral disease except in situ disease, either ductal or lobular of the contralateral breast
* Postmenopausal
* Regardless of prior hormonal replacement therapy (HRT) or hysterectomy:
* Bilateral oophorectomy and any age
* Radiologic castration and amenorrheic for at least 3 months and any age
* Not postmenopausal at the start of adjuvant chemotherapy AND and completed at least 6 courses of prior cyclophosphamide, methotrexate, and fluorouracil (CMF) or at least 4 courses of prior anthracycline-cyclophosphamide continuation therapy and at least age 45 with follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) postmenopausal levels
* No prior HRT:
* Prior hysterectomy and less than age 55 with FSH/LH/E2 postmenopausal levels
* Prior hysterectomy and at least age 55
* No prior HRT or hysterectomy:
* Amenorrhea more than 1 year and less than age 50
* Amenorrhea more than 6 months and at least age 50
* Prior HRT regardless of hysterectomy:
* At least 1 month since prior HRT and less than age 55 with FSH/LH/E2 postmenopausal levels
* At least 1 month since prior HRT and at least age 55
* FSH/LH/E2 postmenopausal levels and uncategorized
* No distant metastases, including bone scans showing hot spots unconfirmed as benign disease or skeletal pain of unknown cause
* At least 10% hormone receptor-positive tumor cells
* Hormone receptor status:
* Estrogen receptor positive AND/OR
* Progesterone receptor positive
PATIENT CHARACTERISTICS:
Age:
* 30 and over
Sex:
* Female
Menopausal status:
* Postmenopausal
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
Hepatic:
* Bilirubin less than 3.0 mg/dL
* SGOT or SGPT less than 1.5 times upper limit of normal
* No hepatic disease that would preclude study
Renal:
* Creatinine less than 1.8 mg/dL
* No renal disease that would preclude study
Cardiovascular:
* No cardiovascular disease that would preclude study
* Prior deep vein thrombosis allowed if medically stable
Pulmonary:
* No lung embolism
Other:
* No other prior or concurrent malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No prior noncompliance to medical regimens
* No other nonmalignant systemic diseases that would preclude follow-up
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior immunotherapy or biological response modifiers (e.g., interferon) allowed
Chemotherapy:
* See Disease Characteristics
* Prior adjuvant or neoadjuvant chemotherapy allowed
* Concurrent adjuvant chemotherapy allowed
Endocrine therapy:
* See Disease Characteristics
* Prior neoadjuvant hormonal therapy allowed (e.g., antiestrogens, progestins, or aromatase inhibitors) if no more than 4 months duration and no disease progression
* Prior corticosteroids allowed
* At least 4 weeks since prior HRT
* Prior adjuvant antiestrogen therapy allowed if less than 1 month duration and immediately after surgery, radiotherapy, and/or chemotherapy
* Prior antiestrogens for chemoprevention allowed if at least 18 months between completion of chemoprevention and diagnosis
* No other concurrent antiestrogens or aromatase inhibitors
* No concurrent raloxifene
* No concurrent systemic HRT with or without progestins of more than 3 months duration
Radiotherapy:
* See Disease Characteristics
* Concurrent radiotherapy allowed
Surgery:
* See Disease Characteristics
Other:
* At least 30 days since prior systemic investigational drugs
* At least 7 days since prior topical investigational drugs
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
120 Years
Study:
NCT00004205
Study Brief:
Protocol Section:
NCT00004205