Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operativ
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual diseas
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery 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 p |
| Who can participate | Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor) and all ER negative (ER \< 10%) breast cancers * Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0 * Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy * Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or on registration) as described in the trial specific MR-Imaging instructions (available on the welcome page of the study specific SecuTrial link) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Klinik Hirslanden, Zurich |
| Locations | Salzburg, Austria; Schwaz, Austria; Vienna, Austria; Frankfurt, Germany; Heidelberg, Germany; Rostock, Germany (+20 more sites) |
| Start date | 2020-08-17 |
| NCT ID | NCT04289935 |
| Official listing | https://clinicaltrials.gov/study/NCT04289935 |