Omitting breast surgery for certain breast cancer patients after treatment
Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial
This study is testing if certain breast cancer patients who show no signs of cancer after treatment can safely skip surgery and still stay cancer-free for five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 533 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05505357 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether breast cancer patients who achieve a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy can safely omit breast surgery without compromising their 5-year disease-free survival. The study is a prospective, multicenter, single-arm non-inferiority trial that will compare outcomes of patients who meet specific imaging criteria to those who undergo traditional surgical intervention. By utilizing advanced imaging techniques and biopsy methods, the trial seeks to optimize treatment approaches for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 20 and older with invasive ductal carcinoma who are expected to achieve a pathologic complete response after neoadjuvant chemotherapy.
Not a fit: Patients with multifocal lesions, distant metastasis, or contraindications to radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgery in select breast cancer patients, leading to improved quality of life and reduced treatment burden.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating that patients meeting stringent imaging criteria may safely forego surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sex: female * Age: 20 years and older * Patients with no clinical/radiologic distant metastasis * Tumor type: Invasive ductal carcinoma * Tumor subtype: HER2 positive(including luminal B type, triple negative * Extent of disease: initial tumor size ≤ 5cm, cN0-2 * Patients with measurable tumor size * Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6) * Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy * Patients with informed consent who are competent to make a voluntary decision Exclusion Criteria: * Multifocal lesion (≥2) * Extent of residual microcalcification after neoadjuvant chemotherapy \> 2cm * Bilateral breast cancer or inflammatory breast cancer * Contraindication to radiotherapy * History of previous contralateral breast cancer * Breast cancer patients with distant metastasis * Allergic history to MRI contrast * Male breast cancer * Patients incapable of giving informed consent owing to poor general conditions * Patients with BRCA mutation * Patients willing to receive breast surgery * Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Han-Byoel Lee — Seoul National University Hospital
- Study coordinator: Han-Byoel Lee
- Email: hblee80@gmail.com
- Phone: +82-2-2072-3447
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.