Omitting breast surgery for certain breast cancer patients after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.