In June of 2022, news outlets all over the world reported the results of the DestinyBreast04 trial, which redefined breast cancer—but more about that soon.

I stood alongside my colleagues as we gave the results of the DestinyBreast04 trial to a standing ovation, and I watched everyone celebrate the advances in breast cancer treatment in awe. More recently, I watched as Katie Couric shared her story of breast cancer, which she made look seamless from the audience’s perspective.

As I watched, I found myself wondering, “How many people understand everything that brought us to this point in breast cancer treatment?”

The importance of clinical trials 

Advances like new definitions of breast cancer, new targeted therapies, or even simpler treatments are only possible through cancer research and clinical trials. Everyone—the community of doctors, patient advocates, non-profit organizations, and government agencies—agrees that clinical trials are not only important, valuable steps in our Cancer Moonshot, but also effective treatment for cancer of any stage, at any time point in a patient’s cancer journey. 

There are many different types of clinical trials. Some compare one medicine to another, while other trials evaluate a medication for the first time. Some clinical trials may assess interventions like technology support tools or lifestyle changes to improve care, while others try to decrease the severity of traditional cancer treatments. 

Furthermore, clinical trials typically look at a specific situation. For example, a trial may focus on a certain type of cancer in women of a certain age group. This kind of trial helps to ensure the treatment(s) being studied is appropriate for the patients potentially volunteering for the clinical trial. 

So how important are clinical trials? The treatments that are considered the current standard of care for a disease, along with all the information in those package inserts that accompany prescriptions, come directly from clinical trials.

What breast cancer research is being done at Lifespan Cancer Institute?

Clinical trials are one of the things that I love about being a medical oncologist. I love that our field is always trying to make cancer care better—better outcomes, fewer or more favorable side effects, better patient experience. 

What predicts the side effects someone might have on immunotherapy? How do older adults with cancer make their decisions about care and how can we better support those decisions? Is oral therapy for breast cancer better if taken longer? Can new medications improve outcomes for patient’s breast cancer? These are all the sorts of trials we have open at the Lifespan Cancer Institute and Legorreta Cancer Institute right now! 

The DestinyBreast04 trial and Enhertu

Back to the DestinyBreast04 trial. This clinical trial looked at a drug called Enhertu® or trastuzumab deruxtecan to determine if it was better than traditional chemotherapy for patients with a certain type of breast cancer known as HER2-Low metastatic breast cancer. 

This trial was novel for two reasons. First, “HER2-Low” is a brand-new concept. Traditionally, breast cancers were considered either HER2 positive or HER2 negative—a binary approach. HER2-low acknowledges that it is more of a grayscale. HER2 expression can range from truly absent, to slightly present, to abundantly present.

Second, the drug Enhertu is what is known as an antibody-drug-conjugate, which means it is chemotherapy bound to a targeting agent, helping the chemotherapy to be delivered to the cancer more effectively. Well, the results earned a standing ovation as I mentioned, for good reason. Enhertu was shown to improve survival for patients with HER2-low breast cancer and is now our new standard of care.

At the Lifespan Cancer Institute and Legorreta Cancer Institute at Brown University, we continue to participate in additional DestinyBreast trials. We now have other generations of these trials, studying this drug in other disease settings and earlier lines of therapy.

Additionally, we have other trials using a new antibody drug conjugate with the same drug (deruxtecan) but a different antibody target. I am excited for patients to be able to access clinical trials like this right at home in Rhode Island, getting cutting edge treatments as they are first being explored. 

Are breast cancer clinical trials right for me? 

Clinical trials are a benefit to patients. Patients always undergo informed consent prior to starting a clinical trial. That means patients understand in advance that their participation is voluntary, what is being studied, and the risks and benefits of participating in the trial.

It’s important that patients: 

  • Be open to clinical trials. Patients should always ask if there are clinical trials available to them and be open to considering such trials.
  • Ask about clinical trials. Patients can and should ask their doctor questions about what makes the trial a good option for them. I want everyone to know that clinical trials are not a “last hope,” but a great treatment option. 
  • Get involved. I also want patients to think about ways they can get involved in clinical research. Are they interested in getting involved in fundraising for cancer research? Or would they consider serving as a patient advocate, providing input and feedback into clinical trials or cancer care delivery? Is there a non-profit organization that you can volunteer time or effort with?

I get excited when I look to the future of breast cancer treatment. I think we are getting better at “right-sizing” treatment for each patient individually. Improvements in care delivery result in better support for patients at every step. 

Visit our website for more information on the Lifespan Cancer Institute and our research studies.

Stephanie Graff, MD

Stephanie L. Graff, MD

Dr. Stephanie Graff is the director of breast oncology at the Lifespan Cancer Institute. Dr. Graff was named "Woman Disruptor of the Year" during the 2022 American Society of Clinical Oncology conference.