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

NCT02564848 | Active Not Recruiting

• 1 other identifier: IIT2015-06-Chung-SNBO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Clinical T1-2N0 ER+; Invasive breast cancer; estrogen-positive

Outcome Measures

Primary Outcomes (1)

• Regional recurrence

  A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes and will be determined by physical exam and breast imaging

  A regional recurrence during six years of follow-up after lumpectomy.

Secondary Outcomes (2)

• Disease-free survival

  From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years.

• Overall survival

  From date of diagnosis until the date of death from any cause assessed up to 5 years.

Study Arms (1)

Lumpectomy without sentinel node biopsy

EXPERIMENTAL

Subjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and hormonal therapy.

Procedure: Lumpectomy without sentinel node biopsy

Interventions

Lumpectomy without sentinel node biopsy PROCEDURE

Biopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy.

Lumpectomy without sentinel node biopsy

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Chung AP, Dang CM, Karlan SR, Amersi FF, Phillips EM, Boyle MK, Cui Y, Giuliano AE. A Prospective Study of Sentinel Node Biopsy Omission in Women Age >/= 65 Years with ER+ Breast Cancer. Ann Surg Oncol. 2024 May;31(5):3160-3167. doi: 10.1245/s10434-024-15000-w. Epub 2024 Feb 12.

  PMID: 38345718 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques

Study Officials

• Alice Chung, MD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 1, 2015
• Study Start: January 22, 2016
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)