Breast Oncologists Aim to Address Key Unanswered Questions With Novel Research Efforts

During the 2020 OncLive^® State of the Science Summit^™ on Breast Cancer, we asked experts from Virginia Cancer Specialists, Georgetown University, Dana-Farber Cancer Institute, and Johns Hopkins Medicine to provide insight on some of the pivotal research being conducted at their respective institutions.

Neelima Denduluri, MD

Neelima Denduluri, MD: Associate Chair of Breast Medical Oncology and Medical Oncologist, Virginia Cancer Specialists, US Oncology Network

“One trial that we’re very excited about is speaking to the theme of hormone receptor (HR)—positive, HER2-negative early breast cancer. While we know that endocrine therapy certainly improves outcomes, as does chemotherapy in selected populations, we still have room to improve. CDK4/6 inhibitors have really moved the field forward in stage IV breast cancer, and we really need to see how that translates into the early breast cancer setting.

Can we improve outcomes beyond endocrine therapy, chemotherapy, and proper localized therapy in these patients? To this end, we have the NATALEE trial open, which is looking at adding a CDK4/6 inhibitor, particularly ribociclib (Kisqali), to endocrine therapy [as adjuvant treatment] in [HR-positive, HER2-negative] early breast cancer that is anatomic stage II or III to see if it improves outcomes.”

Filipa Lynce, MD

Filipa Lynce, MD: Medical Oncologist and Associate Professor of Medicine at Georgetown University, Medstar Health

“Historically, at Lombardi Comprehensive Cancer Center, we have a strong focus on immunotherapy. Many of our clinical trials being developed by our own investigators are focused on immunotherapy, and that is very exciting. In breast cancer in particular, we currently have 2 trials looking at the role of immunotherapy both in the adjuvant setting and in the metastatic setting. In the adjuvant setting, [we’re examining this approach] in combination with chemotherapy or as single agents. In the metastatic setting, [we’re looking at immunotherapies] in combination with PARP inhibitors.”

Sara Tolaney, MD

Sara Tolaney, MD: Associate Director, Susan F. Smith Center for Women’s Cancers, Director, Clinical Trials, Breast Oncology, Senior Physician, Breast Medical Oncologist, Dana-Farber Cancer Institute, and Assistant Professor of Medicine, Harvard Medical School

“Many research efforts are ongoing. One important question that remains unanswered is whether utilizing CDK4/6 inhibitors beyond disease progression would be beneficial. To this end, 1 trial that is being run by a colleague of mine, Erica L. Mayer, MD, MPH, of Dana-Farber Cancer Institute, is the PACE trial; this trial is really trying to address that question of whether or not there is benefit to [CDK4/6] continuation. It’s taking patients who have progressed on up-front aromatase inhibition and CDK4/6 inhibition, and then randomizing them to receive either fulvestrant (Faslodex), fulvestrant with palbociclib (Ibrance), or fulvestrant with palbociclib and avelumab (Bavencio). I’m hopeful that when we get data from this trial, they will really help us answer that [unknown and it will provide us with insight on] how to appropriately treat our patients after CDK4/6 inhibitors.”

Anne Favret, MD

Anne Favret, MD: Medical Oncologist, Virginia Cancer Specialists, The US Oncology Network

“A great trial, the NATALEE trial, is looking at the adjuvant use of a CDK4/6 inhibitor for high-risk disease. We know that these drugs are unbelievably effective in the metastatic setting, so obviously, we want to know if we can cure more patients. If I were a woman with node-positive, estrogen receptor­—positive, HER2-negative breast cancer, I would clamor for this trial, and we have it.”

Jean Wright, MD

Jean Wright, MD: Director of Breast Cancer Program, Department of Radiation Oncology and Molecular Radiation Sciences, and Associate Professor of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine

“I will say that we have opened a proton center in October 2019, and we are going to be enrolling patients on this RadComp study, which is a randomized study between [2 FDA-approved radiation therapies for the treatment of patients with breast cancer]: proton therapy and photon therapy. We’re very excited about that.

Coming back to the worry about the heart [with these therapies], people immediately leap to the [conclusion] that protons must be better because [that approach] could potentially protect the heart better than photons. However, this is an open question that this study aims to answer. It’s our take at Johns Hopkins Medicine that we don’t plan to start treating everyone with protons. We’re really interested in finding out the answer to this question.

We also have an open study that’s looking at omitting radiation therapy in lower-risk women who are between 50 and 75 years of age, based on genomic profiling. A number of the studies that I discussed in my presentation are [trials] that we have available at our center that offer patients many options to consider.”