Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
Running, not enrolling · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02564848
- Run by
- Cedars-Sinai Medical Center
- People needed
- 200
- Starts
- 2016-01-22
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 65 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female age 65 and older
- Staging:
- Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0, ER+, HER2-negative, invasive breast cancer as determined by treating physician. DCIS or LCIS may be present with invasive cancer.
- Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+, HER2-negative, 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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