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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02564848
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Alice Chung, MD, Cedars-Sinai Medical Center

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.

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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 : January 2022
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

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.




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. ]


Information from the National Library of Medicine

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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+ 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+ 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564848


Contacts
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Contact: Parisa Mirzadehgan 310-967-4387 Parisa.Mirzadehgan@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Parisa Mirzadehgan    310-967-4387    Parisa.Mirzadehgan@cshs.org   
Principal Investigator: Alice Chung, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Alice Chung, MD Cedars-Sinal Medical Center
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Responsible Party: Alice Chung, MD, 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    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Alice Chung, MD, Cedars-Sinai Medical Center:
Clinical T1-2N0 ER+
Invasive breast cancer
estrogen-positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases