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 @ 2:34 PM
Ignite Modification Date:
2025-12-24 @ 2:34 PM
NCT ID:
NCT00265759
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* T2-T4c, any N, M0 disease
* Clinically staged, as documented by the treating physician, as 1 of the following:
* T4a-c disease for which modified radical mastectomy with negative margins is the goal
* T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal
* T2 disease for which lumpectomy at first attempt is the goal
* Primary tumor must be palpable and measure \> 2 cm by tape, ruler, or caliper measurements in at least one dimension
* Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy
* No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
* No distant metastasis (M1)
* Isolated ipsilateral supraclavicular node involvement allowed
* No diagnosis that was established by incisional biopsy
* Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8
* Patients with \> 66.66% (two-thirds) of cells staining positive and have a minimum Allred score of 6 are eligible
PATIENT CHARACTERISTICS:
* ECOG/Zubrod performance status of ≤ 2
* Female
* Patient must be postmenopausal, verified by 1 of the following:
* Bilateral surgical oophorectomy
* No spontaneous menses ≥ 1 year
* No menses for \< 1 year with FSH and estradiol levels in postmenopausal range
* No other malignancies within the past 5 years, except for successfully treated cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral ductal carcinoma in situ that was treated with mastectomy or lumpectomy with radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of recurrence
* Must have undergone potentially curative therapy for all prior malignancies AND deemed to be at low risk for recurrence, according to the treating physician
PRIOR CONCURRENT THERAPY:
* No prior treatment for invasive breast cancer, including radiotherapy, endocrine therapy, chemotherapy, or investigational agents
* No prior sentinel lymph node biopsy (cohort B only)
* At least 1 week since prior agents with estrogenic or putatively estrogenic properties, including herbal preparations
* At least 1 week since prior hormone replacement therapy of any type, megestrol acetate, or raloxifene
* No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer
* No other concurrent anti-neoplastic therapy, including chemotherapy or radiotherapy
* No concurrent agents or herbal products that alter ER function
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00265759
Study Brief:
Protocol Section:
NCT00265759