- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07856160
De-escalation of Axillary Dissection for Node-positive Breast Cancer
Feasibility of De-escalation of Axillary Surgery in ycN0 Breast Cancer Patients Post NAC for cN2, cN3 Disease: Evaluating the Concordance Between ypN Status From TAD and ALND
Recent studies have demonstrated the safety of de-escalation of nodal surgery for clinically node-positive breast cancer patients after a favorable response to neoadjuvant systemic therapy (NST). These studies excluded patients with clinically node-positive stage 2 or 3 (cN2, cN3) disease. Consequently, the current guidelines recommend axillary lymph node dissection (ALND) for patients with cN2/cN3 breast cancer, even after a favorable response to NST. Many cN2/cN3 patients achieve nodal pathologic complete response (pCR) after NST, and this has raised interest in less invasive surgical approaches for the management of the axilla in this setting. We aim to evaluate the pathologic concordance between lymph node status post neoadjuvant therapy (ypN) derived from targeted axillary dissection (TAD) and ALND performed sequentially under the same anesthesia in patients with cN2/cN3 who convert to clinically node-negative (ycN0) following completion of NST. If a high level of concordance is determined between the ypN status determined from the TAD and the ALND, our next step would be to expand the trial to include a larger number of patients, making it multi-institutional, in order to power the study for more meaningful analysis.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: IIT Office, MA
- 전화번호: 402-559-4596
- 이메일: IITOffice@unmc.edu
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Females
- Aged ≥ 19 years old at time of study entry.
- Patient must be able to provide study-specific informed consent prior to study enrolment.
- Histological confirmation of breast cancer diagnosis on core needle biopsy. Pathology will be confirmed by internal UNMC review if the biopsy was completed at an outside institution.
- Clinical and/or radiographic cT1-T4 N2-3 M0 disease.
- Patients must complete NST. Patients who complete all recommended cycles of NST, regardless of dose reductions, are eligible.
- Clinical and radiographic (breast MRI with and without contrast) re-evaluation following completion of NST.
- Achievement of a complete clinical and radiographic nodal response (ycN0).
Exclusion Criteria:
- Patients with metastatic disease at presentation.
- Patients unable to complete the recommended NST.
- Patients who are pregnant.
- Patients with a known allergic reaction to injectable blue dye.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment
TAD + ALND |
do alnd after tad |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To evaluate the pathologic concordance between pathologic nodal status (ypN) derived from targeted axillary dissection (TAD) and axillary lymph node dissection (ALND.)
기간: 1 month
|
Pathologic concordance between pathologic nodal status derived from TAD and ALND will be determined based on the pathological results of the two specimens collected. |
1 month
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Janelle-Cheri Millen, MBBS, University of Nebraska
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .