MRI-Guided De-Escalation of Chemotherapy and Immunotherapy in Stage II-III Triple Negative Breast Cancer A Phase 2 Study Evaluating Early Surgery After Initial Treatment Response

What this Trial Is About

Triple-negative breast cancer TNBC is an aggressive form of breast cancer lacking estrogen receptor, progesterone receptor, and HER2 expression, accounting for about 15% of cases and linked to higher risks of early recurrence and death. This trial explores a new approach to treating stage II-III TNBC by using MRI to guide the reduction of chemotherapy intensity after initial treatment, aiming to avoid the more toxic anthracycline drugs in patients who respond well early on. Participants will receive four cycles of paclitaxel-carboplatin combined with pembrolizumab, followed by a breast MRI to assess their response. Those showing a complete radiologic response will proceed directly to surgery, skipping the second phase of anthracycline-containing chemotherapy, while others will complete the full regimen. After surgery, additional treatments may be given based on pathology results and decisions by the patient and doctor. Throughout the study, participants will undergo regular assessments including imaging, blood tests for tumor DNA, and quality of life questionnaires to monitor treatment effects and recovery. The main goal is to measure the rate of complete disappearance of invasive cancer in those with a complete MRI response who have early surgery. The study also tracks survival outcomes and patient experiences over several years, involving about 54 patients in total.

MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC