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
Principal Investigator: Alice Chung, MD, Cedars-Sinai Medical Center, Los Angeles, California
Description: The primary objective of the study is to determine whether not conducting sentinel node biopsy in patients who meet eligibility criteria results in an acceptable regional recurrence rate over a period of 6 years. For the purpose of the trial, researchers defined a regional recurrence as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes, or internal mammary nodes.
Enrolled patients will undergo standard of care lumpectomy without sentinel node biopsy followed by radiation and hormonal therapy. Some patients may have already undergone the procedure prior to enrollment in the study. The patients physician may also determine that the patient requires the receipt of chemotherapy. Researchers will conduct a physical examination of the affected breast and regional lymph nodes every 6 months for the first 2 years of follow up and then every year for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.
While the primary outcome of the trial is regional recurrence, secondary outcome measures include disease-free survival and overall survival.
To review the full list of inclusion and exclusion criteria please refer to the reference.
Status: This trial is ongoing and recruiting patients as of October 1, 2015.
This study is sponsored by Cedars-Sinai Medical Center.
Clinicaltrials.gov. Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65. NCT02564848. https://clinicaltrials.gov/ct2/show/NCT02564848. Accessed October 15, 2020.