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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00005957
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven invasive carcinoma of the breast
* No evidence of T4, N2-3, or M1 disease prior to surgery
* Node positive or high-risk node negative
* Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT
* Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision
* Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site
* Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria
* If node positive, then a level I and II axillary dissection must be performed
* No evidence of residual disease in axilla after dissection
* Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy
* High risk of regional and systemic recurrence due to one of the following:
* Pathologically positive axillary lymph nodes
* Pathologically negative axillary lymph nodes with one of the following:
* Primary tumor greater than 5 cm
* Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:
* Estrogen receptor negative
* Skarf-Bloom-Richardson grade 3
* Lymphovascular invasion
* Hormone receptor status:
* Estrogen and progesterone receptor status known
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Sex:
* Female
Menopausal status:
* Premenopausal or postmenopausal
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years
Hematopoietic:
* Not specified
Hepatic:
* SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)\*
* Alkaline phosphatase no greater than 3 times ULN\* NOTE: \* Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations
Renal:
* No serious nonmalignant renal disease
Cardiovascular:
* No serious nonmalignant cardiovascular disease
Pulmonary:
* No serious nonmalignant pulmonary disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy
* No other malignancy except:
* Nonmelanomatous skin cancer
* Carcinoma in situ of the cervix or endometrium
* Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
* Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
* No psychiatric or addictive disorder that would preclude informed consent or study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Concurrent standard adjuvant chemotherapy allowed
Endocrine therapy:
* See Disease Characteristics
* Concurrent standard adjuvant hormonal therapy allowed
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
120 Years
Study:
NCT00005957
Study Brief:
Protocol Section:
NCT00005957