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Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65

Active Not RecruitingNA

Sponsor: Cedars-Sinai Medical Center

Conditions: Breast Cancer

Interventions: Lumpectomy without sentinel node biopsy

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 65 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female age 65 and older
* Staging:

  1. 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.
  2. 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

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

Locations (1)

Los Angeles, California, United States