RESPONDER AI - Reliable exclusion of residual cancer after neoadjuvant systemic treatment for women with breast cancer by an intelligent vacuum-assisted biopsy

• Applicant: Professor Dr. Jörg Heil
• Subject Area: Gynaecology and Obstetrics
• Term: since 2024
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 469936508

In recent years, neoadjuvant systemic treatments have gained clinical relevance and are nowadays recommended for women with triple-negative, HER2 positive, or (high proliferative) Luminal B breast cancers. Increasing use of neoadjuvant systemic treatment (NAST) and improved efficacy of treatment regimens have led to increasing numbers of patients without any detectable residual cancer upon surgery (pathologic complete response, pCR, ypT0 and ypN0). For these exceptional responders to NAST, surgery may be overtreatment: all local tumor has already been eradicated by NAST. Breast conserving surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) is the current standard of care. The use of NAST instead of adjuvant treatment has facilitated more BCS instead of mastectomy with equal survival. Although BCS is a low morbidity procedure compared to other oncologic surgeries, it causes morbidity relevant to patients: (1) About 30% of patients undergoing BCS and SLNB report moderate, persistent pain two years after surgery (2) the reduction in patient-reported quality of life up to 8 years after surgery is comparable between patients undergoing BCS or mastectomy. Thus, although women diagnosed with breast cancer are more likely than ever to survive their diagnosis, many must contend with the long-term effects of their treatment on quality of life. In the light of increasing ypT0 rates, current research evaluates alternative diagnostic procedures than BCS to identify these exceptional responders to NAST who achieve ypT0. For this purpose, our research group has developed a so-called intelligent vacuum-assisted biopsy (VAB). The use of a diagnostic intelligent VAB may potentially spare these women diagnostic axillary and breast surgery in the future. Quantifying the relevance of this topic, we estimate that about 10% of all breast cancer patients might be spared surgery in the future. In this multicenter, prospective, confirmatory trial we aim to prove that an intelligent VAB is as accurate as surgery to reliably exclude residual cancer after NAST. If this evidence could be obtained, a subsequent randomized controlled trial may evaluate the long-term oncologic safety of omitting breast and axillary surgery for these exceptional responders to NAST. The trial could therefore lead to a fundamental change of clinical practice for about 10% of all women with breast cancer.

• DFG Programme: Clinical Trials
• Co-Investigator: Dr. André Pfob