Evaluating lymph node biopsy accuracy after chemotherapy for advanced breast cancer
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study
This study is testing how well a specific type of lymph node biopsy can find leftover cancer in women with advanced breast cancer after they have received chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Miami, Florida and 7 other locations) |
| Trial ID | NCT03255577 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of the sentinel lymph node biopsy (SLNB) procedure in detecting residual cancer cells in patients with locally advanced breast cancer who have undergone neoadjuvant chemotherapy. Female patients over 18 years with biopsy-proven breast cancer and specific clinical characteristics will be included. The study will involve surgical intervention to perform SLNB and evaluate its effectiveness in identifying remaining cancer post-chemotherapy. The findings could help refine treatment approaches for this patient population.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 with biopsy-confirmed locally advanced breast cancer who have received neoadjuvant chemotherapy.
Not a fit: Patients with a history of ipsilateral breast cancer or persistent palpable axillary nodes after chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of cancer staging and treatment decisions for patients with locally advanced breast cancer.
How similar studies have performed: Previous studies have shown promise in using SLNB after neoadjuvant chemotherapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients over 18 years of age with biopsy-proven breast cancer * Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging * Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies * Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam Exclusion Criteria: * Patients with a prior history of ipsilateral breast cancer * Pregnant patients * Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam * Patients not consenting to ALND
Where this trial is running
Miami, Florida and 7 other locations
- BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami, Florida, United States (Recruiting)
- Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent only and Follow Up) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent only and Follow Up) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Barrio, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Andrea Barrio, MD
- Email: barrioa@mskcc.org
- Phone: 646-888-5117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.