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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT01960803
Eligibility Criteria:
Inclusion Criteria:
* Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
* Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
* Peri or post-menopausal women age \> 50, defined as women who have experienced no menstrual period in the past 6 months or more
* BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
* Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
* Grade 1, 2, or 3 acceptable
* Associated LCIS is allowed
* Pure DCIS allowed if \<2.5 cm, low to intermediate nuclear grade and resected margins negative at \> 3 mm (per ASTRO criteria)
* Estrogen receptor (ER) status of positive
* Patient has clear margins \>2 mm on gross pathologic examination
* Patient is node-negative, defined as N0 (i-) or N0 (i+)
* Patient must be deemed functionally and mentally competent to understand and sign the informed consent
* Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy
Exclusion Criteria:
* Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years
* Immunocompromised status
* Pregnancy
* Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
* Breast cancer that involves the skin or chest wall, locally advanced breast cancer
* Invasive lobular carcinoma
* Evidence of lymphovascular invasion (LVI)
* Invasive carcinoma with extensive intraductal component (EIC)
* Neoadjuvant chemotherapy
* Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
* Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
95 Years
Study:
NCT01960803
Study Brief:
Protocol Section:
NCT01960803