Shayna L. Showalter, MD, (left) and Trish Millard, MD (photo credit Harry Moxley)
Shayna L. Showalter, MD, is a professor of surgery in the UVA Department of Surgery, Division of Surgical Oncology. As a breast surgical oncologist, she specializes in the multi-disciplinary treatment of breast cancer. She is also the associate chief medical officer for Surgical Ambulatory Services for UVA Health.
In addition to her clinical and leadership duties, Dr. Showalter leads the multi-site, phase III clinical trial, “The Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women with Early-Stage Breast Cancer: The POWER II Trial.” Trish Millard, MD, an associate professor in the Department of Medicine, Division of Hematology & Oncology, serves as principal investigator for the study’s UVA site. Drs. Showalter and Millard see patients at the UVA Health Breast Care Center, which offers the latest technology, medical and surgical expertise, and support services for breast cancer patients.
In the Power II Trial, Drs. Showalter and Millard and their clinical research team are focused on the treatment of early-stage breast cancer in older women (65+). The goal of the study is to tailor treatment to each individual patient, rather than a “one-size fits all” model.
We recently talked with Dr. Showalter about the Power II Trial for our Medicine in Motion series “A Healthier Future — One Clinical Trial at a Time.”
Q. What do you hope to learn from this study? Will the results potentially change the standard of care for future patients?
Showalter: Early-stage breast cancer is traditionally treated by lumpectomy followed by radiation therapy and 7-10 years of adjuvant endocrine therapy. Previous studies have shown that it is safe to omit radiation therapy in women 65 and older who take adjuvant endocrine therapy. However, due to side effects, adherence to endocrine therapy is low, especially in older women. Therefore, many women are still treated with radiation therapy, raising concern for over-treatment. Conversely, there are patients who omit radiation therapy and are not able to tolerate adjuvant endocrine therapy and thus are at risk for under-treatment and worse oncologic outcomes.
In the POWER I Trial, a multi-site phase II trial that we designed and recently completed, patients were treated with 90 days of pre-operative endocrine therapy (pre-ET) as a window to establish tolerance. We found that 90 days of pre-ET influenced both patient and physician preferences regarding radiation therapy. The POWER I trial validated pre-ET as a tool to inform radiation therapy decisions.
In the POWER II trial, participants are randomized to be treated with pre-ET prior to lumpectomy or standard of care, in which case they will proceed directly to breast surgery. In both arms of trial, the patients and their physicians will decide about radiation therapy.
The purpose of the POWER II trial is to determine whether 90 days of pre-ET results in a decrease in both over- and under-treatment of early-stage breast cancer in older women.
Q. Does your trial give novel treatment or other opportunities to your/our patients?
Showalter: Yes, this trial is aimed to determine if patients that are treated with pre-ET, prior to making decisions about radiation therapy, will decrease over- and under-treatment of breast cancer by informing their decisions based on the side effects experienced in the pre-operative window. This is a randomized trial, so 50% of the patients will receive pre-ET and 50% will be treated with the standard order of treatments.
Q. What is novel about your study design/treatment/intervention?
Showalter: The concept of pre-ET, which allows patients to experience the side effects of endocrine therapy prior to making decisions about radiation therapy is novel. We first introduced pre-ET in the POWER I Trial, which validated it as a tool to inform adjuvant therapy decisions by patients and recommendations by physicians.
Q. How will you ensure inclusion of a diverse subject population?
Showalter: At the UVA Breast Care Center, we are committed to offering clinical trials to all eligible patients throughout our catchment area. To make the POWER II trial as easy as possible for participants we have streamlined processes. We screen patients in advance of their initial surgical oncology appointment and coordinate the requisite medical oncology appointments in advance to avoid patients needing to make multiple trips. We treat a significant number of patients that travel several hours to UVA and this structure facilitates efficient care and does not add burden to the patients who are already dealing with the stress of a new breast cancer diagnosis.
The Power II Trial has recently opened at Virginia Commonwealth University, which will also increase the diversity of the participants. We plan to expand the trial to an additional 4-5 sites.
Filed Under: Research