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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Lumpectomy without sentinel node biopsy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Disease-free survival [ Time Frame: From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years. ]
- Overall survival [ Time Frame: From date of diagnosis until the date of death from any cause assessed up to 5 years. ]
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
|Contact: Parisa Mirzadehgan||310-967-4387||Parisa.Mirzadehgan@cshs.org|
|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|
|Principal Investigator:||Alice Chung, MD||Cedars-Sinal Medical Center|