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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT00527293
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer, including the following histologic subtypes:
* Invasive ductal carcinoma
* Medullary ductal carcinoma
* Papillary ductal carcinoma
* Colloid (mucinous) ductal carcinoma
* Tubular ductal carcinoma
* The following histologic subtypes are not allowed:
* Invasive lobular carcinoma
* Extensive lobular carcinoma in situ
* Ductal carcinoma in situ (DCIS)
* Nonepithelial breast malignancies, such as lymphoma or sarcoma
* No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
* Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
* Lesion ≤ 3 cm
* No more than 3 positive lymph nodes
* Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
* Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
* Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
* Unifocal breast cancer
* No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
* No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
* No skin involvement of disease
* No Paget's disease of the nipple
* No distant metastatic disease
* Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* Not pregnant or lactating
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
* No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
* No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
* No other malignancy within the past 5 years, except non-melanomatous skin cancer
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy to the breast
* No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
* Concurrent hormonal therapy allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00527293
Study Brief:
Protocol Section:
NCT00527293