A Study of the Use of Sentinel Lymph Node Biopsy in Women With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Breast Conservation Therapy
|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: NCT04854005|
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : October 4, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: Breast-conserving surgery|
|Study Type :||Observational|
|Estimated Enrollment :||147 participants|
|Official Title:||Selective Use of ALND in cT1-2N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Conservation: A Prospective Study|
|Actual Study Start Date :||April 20, 2021|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
Patients with cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo BCS will undergo in-house AUS to characterize suspicious-appearing lymph nodes, as is part of routine practice.
Procedure: Breast-conserving surgery
Patients will undergo SLNB with dual-tracer mapping with technetium-99m sulfur colloid and lymphazurin blue dye, in accordance with routine clinical practice.
- evaluate rates of axillary lymph node dissection [ Time Frame: 2 years ]Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.
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): NCT04854005
|Contact: Anita Mamtani, MDfirstname.lastname@example.org|
|Contact: Monica Morrow, MD||646-888-5384|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Anita Mamtani, MD 646-888-6864|
|Principal Investigator: Anita Mamtani, MD|
|Principal Investigator:||Anita Mamtani, MD||Memorial Sloan Kettering Cancer Center|