Project

SAKK 23/18 Vision I

Ongoing - recruitment active ยท 2020 until 2024

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Status
Ongoing - recruitment active
Start Date
2020
End Date
2024
Financing
Others
Keywords
Vacuum assisted biopsy, before Surgery as an Intra- or pre-Operative surrogate, patient response to Neoadjuvant chemotherapy, breast cancer
Homepage
Brief description/objective

Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option of breast conserv-ing surgery, has lately become common practice in the primary treatment of breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as it depends on several factors such as biological subtype, the used chemotherapy regimen and anatomic stage. The most common imaging methods beside clinical examination are breast ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery (and the standardized assessment of resected tissue) is so far the only valid option to either ascertain complete response or to remove the complete residual disease. Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. We will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.