About this trial
S1418/BR006 is a randomized Phase III Trial to evaluate the efficacy and safety of pembrolizumab as adjuvant therapy for Triple Receptor-Negative Breast Cancer with > 1 cm residual invasive cancer or positive lymph nodes (>pN1mic) after neoadjuvant chemotherapy.Why this trial is important
The prognosis of patients with triple-negative breast cancer (TNBC) who have extensive residual cancer after neoadjuvant chemotherapy is poor. The risk of distant recurrence can be as high as 40-50% within the first 3-5 years and metastatic recurrences are uniformly fatal. Pembrolizumab has been well tolerated and has shown promising results in the early phase trials in breast cancer. The I-SPY2 pembrolizumab trial has shown better pCR rates in patients with locally advanced breast cancer receiving pembrolizumab with paclitaxel in the neoadjuvant setting.Who qualifies
Patients who have TNBC with residual invasive breast cancer, as defined by the 2010 and 2013 ASCO CAP guidelines, after completion of neoadjuvant chemotherapy. Residual disease must be ≥ 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) on pathologic exam. Patients may receive postoperative adjuvant chemotherapy with 6-8 cycles of capecitabine before enrolling in the study.Frequently asked questions (FAQ) about this trial:
Is central path review required for S1418?
Can a patient enroll if she is receiving Xeloda?
Can a patient enroll if she is currently receiving radiotherapy?
How do you sequence radiotherapy and pembrolizumab in this study?
Are BRCA1/2 mutation carriers eligible for S1418?
How do I talk to patients about this trial?
Clinical trials offer an opportunity to receive tomorrow’s therapies today. Patients whose TNBC is not completely eradicated by preoperative chemotherapy are at risk for metastatic recurrence. You can reduce this risk by taking capecitabine chemotherapy for 4-6 months after chemotherapy. However, one in five patients will still relapse despite capecitabine, with large amounts of residual cancer this risk could be even higher.
We are not happy with this outcome and try to explore additional treatment options to reduce risk of recurrence. Immunotherapy drugs that “rev up“ the immune system against cancer emerged as the most exciting advance in cancer and several of these drugs are now approved to treat various cancers, but not yet breast cancer. You have the opportunity to participate in a trial that randomly assigns half of the patients to receive one year of immunotherapy or no further treatment beyond what is the best current standard of care. In other words, everybody completes the best standard of care but half of the patients will continue to receive additional therapy. The goal of the study is to test if patients who receive the immunotherapy have fewer recurrences, or not. Are you interested to learn more about the trial and would consider participating?
About the PI (Lajos Pusztai, MD, PhD)
