Clinic Conversation of the Week: How to Talk With Patients About the FDA Approval of Datopotamab Deruxtecan for Breast Cancer

Jasmin Hundal, MD, MS, MPH: Welcome to this Clinic Conversation of the Week, where we discuss groundbreaking research with our patients in the clinic. Today, I’ll be discussing the recent FDA approval of datopotamab deruxtecan (Dato-DXd) for hormone receptor (HR)–positive, HER2-negative metastatic breast cancer. This approval is based on the phase 3 TROPION-Breast01 trial, which evaluated Dato-DXd in patients whose cancer had progressed despite prior hormone therapy and chemotherapy. The goal of this series is to discuss the data with patients as if they were our own in the clinic, having real conversations about what this new treatment means for them. In this edition, I’ll talk about how Dato-DXd works, what the clinical trial showed, and how we can balance the excitement of this approval with a discussion of side effects and practical considerations in patient care.

Here’s What I Would Say

“Breast cancer that continues to grow after multiple treatments can be really difficult to manage, and I know that can feel overwhelming. I want to talk with you about a new treatment option that was recently approved, called datopotamab deruxtecan, or Dato-DXd. It’s a type of therapy designed specifically for patients with HR-positive, HER2-negative metastatic breast cancer who have already been treated with hormone therapy and at least one or two lines of chemotherapy.

Dato-DXd is a targeted therapy known as an antibody-drug conjugate, or ADC. That means it works a little differently from traditional chemotherapy. Instead of affecting all rapidly dividing cells, it delivers chemotherapy directly to cancer cells by targeting a protein called Trop2, which is found on many breast cancer cells. By doing this, it helps to destroy the cancer while minimizing harm to healthy cells. The idea is that this approach may help reduce some of the side effects that we see with standard chemotherapy.

The approval of this drug was based on a large clinical trial called TROPION-Breast01. In this study, patients who received Dato-DXd had more time before their cancer worsened compared to those who got standard chemotherapy. It also helped shrink tumors in more patients and delayed the need for another treatment. This is a really promising option for people whose cancer has become resistant to other therapies.

Of course, like any treatment, Dato-DXd does come with some side effects. The most common ones we saw in the trial were nausea, mouth sores, fatigue, and dry eyes. Some patients did experience more serious side effects, like lung inflammation, though this was rare, but it requires careful monitoring. Compared to traditional chemotherapy, Dato-DXd had fewer severe side effects overall, which is an important consideration when choosing a treatment.

So, what does this mean for you? If your cancer has continued to grow after hormone therapy and chemotherapy, Dato-DXd may be a good option. It works differently than standard chemotherapy, which means it could provide a better balance between effectiveness and side effects. Your oncologist can help you decide whether this treatment makes sense for you based on your medical history and overall health. We’ll work together to make sure you have all the information you need to make the best decision for your care.”

About Dr. Hundal

Jasmin Hundal, MD, MS, MPH, is a second-year Hematology/Oncology Fellow at the Cleveland Clinic in Cleveland, Ohio. Previously, she completed her Internal Medicine Residency at the University of Connecticut. Dr. Hundal’s main area of interest is the overlap between cardiometabolic health and cancer, particularly for breast cancer patients and survivors. Outside of work, she enjoys traveling, cooking, and hiking.