Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without
 sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative
 breast cancer. Clinically node-negative means that during a physical exam your doctor cannot
 feel or see that any lymph nodes near the breast area are swollen and there is also no
 imaging evidence, such as from a mammogram, of nodal involvement.
The primary objective of the study is to determine whether omission of sentinel node biopsy
 in patients who meet eligibility criteria results in an acceptable regional recurrence rate
 over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral
 axillary nodes, supraclavicular nodes or internal mammary nodes.

 Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy
 followed by radiation and hormonal therapy or have already undergone the procedure prior to
 enrollment in the study. She may also receive chemotherapy as determined by her treating
 physician. A physical examination of the affected breast and regional lymph nodes will be
 conducted every six months for the first two years of follow up and then yearly for the last
 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery
 per standard of care.
Inclusion Criteria:

 -  Female age 65 and older

 -  Staging:

 1. Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0 ER+ invasive
 breast cancer as determined by treating physician. DCIS or LCIS may be present
 with invasive cancer.

 2. Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+ invasive breast cancer.
 DCIS or LCIS may be present with invasive cancer.

 -  Plan to undergo lumpectomy within 3 months of study registration, or underwent
 lumpectomy within 60 days of study registration (without sentinel node biopsy)

 -  Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal
 tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven
 nodal metastases are excluded

 Exclusion Criteria:

 -  Patients with diagnosis of ductal or lobular carcinoma in situ

 -  Patients with diagnosis of inflammatory breast cancer

 -  Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer
 (past treatments for other cancers are acceptable)

 -  Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast

 -  Prior history of ipsilateral (invasive or DCIS) breast cancer

 -  Diagnosis of clinical T3 or T4 breast cancer