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

• ClinicalTrials.gov Identifier: NCT02564848
• Recruitment Status: Recruiting
• First Posted: October 1, 2015
• Last Update Posted: January 18, 2023
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Alice Chung, Cedars-Sinai Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Lumpectomy without sentinel node biopsy	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: IIT2015-06-Chung: Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Clinical T1-2 Estrogen-Positive Breast Cancer Over Age 65
• Actual Study Start Date: January 22, 2016
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lumpectomy without sentinel node biopsy; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Regional recurrence [ Time Frame: A regional recurrence during six years of follow-up after lumpectomy. ]
   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

Secondary Outcome Measures :

1. Disease-free survival [ Time Frame: From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years. ]
2. Overall survival [ Time Frame: From date of diagnosis until the date of death from any cause assessed up to 5 years. ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Amy Oppenheim; 310-423-3713; Amy.Oppenheim@cshs.org

Locations

United States, California

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Amy Oppenheim 310-423-3713 Amy.Oppenheim@cshs.org

Principal Investigator: Alice Chung, MD

Sub-Investigator: Farin Amersi, MD

Sub-Investigator: Catherine Dang, MD

Sub-Investigator: Armando Giuliano, MD

Sub-Investigator: Scott Karlan, MD

Sub-Investigator: Edward Phillips, MD

Sub-Investigator: Jerrold Steiner, MD

Sub-Investigator: Stephen Shiao, MD

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Alice Chung, MD; Cedars-Sinal Medical Center

More Information

• Responsible Party: Alice Chung, Assistant Professor of Surgery, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02564848
• Other Study ID Numbers: IIT2015-06-Chung-SNBO
• First Posted: October 1, 2015
• Last Update Posted: January 18, 2023
• Last Verified: January 2023

Keywords provided by Alice Chung, Cedars-Sinai Medical Center:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases