Current Trials for Treatment of Early Stage TNBC

EP: 1.Standard of Care for Early-Stage TNBC

EP: 2.Role of pCR in Early Stage TNBC Management

EP: 3.Key Trials in ICI-Based Therapy for Early Stage TNBC

EP: 4.Early Stage TNBC: Phase 3 IMpassion031 Study

EP: 5.Role of Immune Checkpoint Inhibitor-Based Therapy in ES TNBC

EP: 6.ICI-Based Therapy in TNBC: Immune-Related Adverse Events

EP: 7.Emerging Data on Biomarkers in ES TNBC

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EP: 8.Current Trials for Treatment of Early Stage TNBC

EP: 9.Standard of Care for Metastatic TNBC

EP: 10.KEYNOTE-355 Trial in mTNBC

EP: 11.Testing for PD-L1 Expression in mTNBC

EP: 12.Standard of Care for BRCA+ mTNBC

EP: 13.Sequencing Therapies for mTNBC

EP: 14.Phase 3 ASCENT Trial in mTNBC

EP: 15.Phase 3 ASCENT Trial in mTNBC: Managing Adverse Events

EP: 16.Future Directions for Treatment of TNBC

Joyce A. O’Shaughnessy, MD: Just to finish the early-stage setting, I’m just going to turn us to Sara Tolaney. We definitely have an unmet need. No question. Thankfully, there are a number of hypotheses being looked at. I want to get Sara’s take. What do you think are some of the more promising strategies and some of the clinical trials that are ongoing to get us to the next level of benefit?

Sara Tolaney, MD, MPH: A lot of the trials in the early disease setting are trying to say, “How can we improve outcomes for our highest-risk patients?” For example, the patients who have residual disease. Can we do better, potentially, then capecitabine is doing based on CREATE-X? We have trials that are comparing capecitabine with platinum therapy. That’s being done through the ECOG trial. I think we’ll learn more if there is a difference in outcomes.

There is a study that’s starting called the SASCIA trial, which is going to compare sacituzumab with treatment of choice in patients with residual disease. That’s particularly exciting because I think that sacituzumab seems to work really well in a refractory population. Maybe in this residual disease population that will have significant benefit. Then there are also studies that are looking at immunotherapy in patients with residual disease. This is going to be challenging because those trials are really focused on patients who didn’t get preoperative immunotherapy. We’ll learn if there is a benefit in the adjuvant setting in that population. Obviously this whole paradigm could shift if immunotherapy really does become part of the standard preoperative setting, as well as the adjuvant setting.

That was the way both IMpassion031 and KEYNOTE-522 still continued the I/O [immuno-oncology] even after surgery. The space is rapidly changing. There are also approaches about potentially trying to substitute different chemotherapies in the early disease setting. There’s even a study looking at sacituzumab in the preoperative setting. The idea is if we could see a really good pCR [pathologic complete response] with sacituzumab preoperatively, could this potentially even substitute for anthracycline as a backbone? We have a lot to learn, but definitely a lot of work is being done to see if we can improve outcomes compared with our current standards.

Joyce A. O’Shaughnessy, MD: Thank you. We’ll have to stay tuned. We’ll have to have a lot more of these discussions over the year, so don’t go anywhere anybody. We’ll have to keep talking. There is a lot of promise, but the immunotherapy is definitely the thing we’re going to be watching most closely in the curative setting. Thank you, guys, very much for a great discussion.

Transcript Edited for Clarity