Neoadjuvant Therapy Breast Neoplasms
Conditions
Interventions
Complete resection (removal) of lesions using vacuum-assisted biopsy with the intention of completely removing lesions or tumor beds previously marked or visible on ultrasound up to 2 cm. This is an o
s routine. The clip insertion and vacuum-assisted tumor removal procedures will take place in breast imaging clinics, lasting approximately 30 minutes, and will be performed only once for each study p
Sponsors
Empresa Brasileira de Serviços Hospitalares
Empresa Brasileira de Serviços Hospitalares
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: patients (women) after neoadjuvant systemic treatment for breast cancer; with pre-systemic treatment tumors smaller than or equal to 5 centimeters; with a clinically normal armpit or with a slight suspicion of involvement by breast cancer; single vision; with post-neoadjuvant residual lesions smaller than or equal to 2 centimeters; with a clinically normal armpit or with a slight suspicion of involvement by breast cancer; no residual lesion after neoadjuvant treatment (complete clinical response); with tumor bed marked with systemic pre-treatment clip; with a clinically normal armpit or with a slight suspicion of involvement by breast cancer; over the age of 18
Exclusion criteria
Exclusion criteria: patients with locally advanced tumors; patients with breast implants undergoing percutaneous vacuum excision; legally incapable patients; pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| it is expected that the ultrasound- or mammography-guided vacuum-assisted resection method, as appropriate for each case, in the management of residual lesions up to 2.0 cm and tumor beds after neoadjuvant systemic treatment for breast cancer, will have complete resection rates similar to those of conventional surgery, allowing this technique to be considered non-inferior to the standard technique (conventional surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| secondarily, it is expected that vacuum-assisted resection will have good accuracy in predicting the rate of complete pathological response after neoadjuvant systemic treatment; that the false negative rate of percutaneous vacuum-assisted resection will be less than 10% and that resection of the excision margins will contribute to reducing this rate; that clipping of the tumor bed before neoadjuvant systemic treatment will also contribute to reducing this rate; that we can observe whether tumor characteristics are related to complete resection rates; and that we can describe the main complications and limitations of the vacuum-assisted resection technique observed in our study | — |
Countries
BR
Contacts
Public ContactKatyane Alves
Empresa Brasileira de Serviços Hospitalares
Outcome results
None listed