Selective Use of ALND in N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 78
- Locations
- 19
- Primary Endpoint
- evaluate rates of axillary lymph node dissection
Study Overview
Brief Summary
The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery. The study researchers think that, if AUS before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥18 years with biopsy-proven invasive breast cancer
- •Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery
- •Patients with tumors of the HR+/HER2- subtype, defined as:
- •HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei
- •HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay
Exclusion Criteria
- •Patients with prior ipsilateral breast cancer
- •Patients who are pregnant
- •Patients with stage IV disease at presentation
- •Patients with advanced regional disease (cN2/cN3)
Arms & Interventions
Breast Cancer
Patients with cTx/cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo AUS at the enrolling institution to characterize suspicious-appearing lymph nodes, as is part of routine practice.
Intervention: Breast surgery (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported