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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumpectomy without sentinel node biopsy
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Clinical T1-2N0 ER+, Invasive breast cancer, estrogen-positive

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumpectomy without sentinel node biopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease-free survival
Overall survival

Full Information

First Posted
September 25, 2015
Last Updated
July 18, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02564848
Brief Title
Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2016 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Clinical T1-2N0 ER+, Invasive breast cancer, estrogen-positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumpectomy without sentinel node biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumpectomy without sentinel node biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Regional recurrence
Description
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
Time Frame
A regional recurrence during six years of follow-up after lumpectomy.
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years.
Title
Overall survival
Time Frame
From date of diagnosis until the date of death from any cause assessed up to 5 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Oppenheim
Phone
310-423-3713
Email
Amy.Oppenheim@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Chung, MD
Organizational Affiliation
Cedars-Sinal Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Oppenheim
Phone
310-423-3713
Email
Amy.Oppenheim@cshs.org
First Name & Middle Initial & Last Name & Degree
Alice Chung, MD
First Name & Middle Initial & Last Name & Degree
Farin Amersi, MD
First Name & Middle Initial & Last Name & Degree
Catherine Dang, MD
First Name & Middle Initial & Last Name & Degree
Armando Giuliano, MD
First Name & Middle Initial & Last Name & Degree
Scott Karlan, MD
First Name & Middle Initial & Last Name & Degree
Edward Phillips, MD
First Name & Middle Initial & Last Name & Degree
Jerrold Steiner, MD
First Name & Middle Initial & Last Name & Degree
Stephen Shiao, MD

12. IPD Sharing Statement

Learn more about this trial

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

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