Celebrating new therapies, addressing challenges, and committing to patient advocacy
I was thrilled to attend the 2024 San Antonio Breast Cancer Symposium (SABCS) December 10-13, 2024. With the increasing need to develop new therapies for breast cancer, the SABCS has grown rapidly. This year the symposium experienced record-breaking attendance with more than 11,000 delegates and over 110 exhibitors from more than 100 countries. Additionally, more than 2,100 abstracts were presented.
In addition to celebrating approvals for new treatments for human epidermal growth factor receptor 2 (HER2) breast cancer, significant themes at SABCS included the need to reduce ovarian toxicity, focus on prevention and early detection measures, and enhance patient advocacy, clinical trial education, and diversity initiatives.
Increasing treatments for HER2 breast cancer
Everyone was abuzz at SABCS about the significant cyclin-dependent kinases (CDK) 4/6 inhibitor treatments for HER2 breast cancer approved in 2024 by the U.S. Food and Drug Administration (FDA). CDK 4/6 inhibitors, such as palbociclib and ribociclib, can slow down and halt the proliferation of cancer cells. While the first CDK 4/6 inhibitor received approval a decade ago, and CDK 4/6 inhibitors are now considered standard treatment for breast cancer, these latest approvals represent promising advancements in their use and effectiveness.
- Palbociclib (Ibrance): Palbociclib, approved in December, targets enzymes CDK 4 and 6, which play crucial roles in cell division and growth. Palbociclib was granted approval based on the results of the PATINA trial, which validated significant delay—26%—in cancer progression when used in combination with HER2-targeted and hormonal-based therapies for treating HER2-positive, hormone receptor (HR)-positive metastatic breast cancer.
- Ribociclib (Kisqali): Ribociclib received approval in September in combination with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative early breast cancer at high risk of recurrence. The approval was supported by the NATALEE trial that demonstrated significant improvement in invasive disease-free survival (iDFS) for patients—25% reduction in the risk of recurrent invasive disease compared to hormone therapy alone.
Reducing ovarian toxicity
A pressing topic at this year’s SABCS was the continued need to reduce ovarian toxicity in breast cancer therapy. Dr. Antonio Wollf, Professor of Oncology at Johns Hopkins University and Director of Breast Cancer Trials in the Women’s Malignancies Program at the Johns Hopkins Kimmel Comprehensive Cancer Center, highlighted this important topic in a special session.
While chemotherapy can be an effective treatment for breast cancer, the side effects can cause serious side effects on ovaries and overall gynecological health including hot flashes, genitourinary (GU) symptoms, early menopause, menstrual cycle changes, sexual dysfunction, accelerated bone loss, and cardiovascular disease. With more women waiting to have children, the harmful effects of chemotherapy on fertility have also become critical issues.
Researchers are tackling this issue in a few different ways. One approach is the use of gonadotropin-releasing hormone (GnRH) agonists alongside chemotherapy to suppress ovarian function during treatment. There is also a push to collect and more carefully monitor data on ovarian function during breast cancer trials. The FDA has also emphasized the need to address ovarian toxicity with its November 2024 draft guidance.
Committing to patient advocacy
A breast cancer diagnosis can be stressful for patients, their families and caregivers. SABCS dedicated valuable time in this year’s program to highlight the important role patient advocacy plays in breast cancer treatment and support.
- The Metastatic Breast Cancer Alliance held a workshop on “The Do’s and Don’ts of Communication on Advanced/Metastatic Breast Cancer.” During the session, presenters walked session attendees through best practices and helpful tips for communicating with their patients about disease diagnosis, progression, and clinical trial opportunities.
- Alamo Breast Cancer Foundation and the National Breast Cancer Coalition Fund partnered for the Project LEAD Advanced Topics education class at SABCS. This educational program provides patient advocates with clinical science updates and prepares them to attend and effectively engage in the SABCS sessions.
Focusing on prevention and early detection
While promising treatments for breast cancer are a cause for celebration, most agree that the optimal scenario remains early detection or prevention altogether.
For example, the COMET trial, which compared active monitoring with standard treatment (surgery with or without radiation) for patients with HR-positive, HER2-negative, low-risk ductal carcinoma in situ (DCIS), found that patients who opted for active monitoring had similar clinical outcomes as those receiving standard treatment. This outcome suggests that active monitoring might be a viable option for managing low-risk DCIS.
Enhancing clinical trial education
The need to increase awareness and education about clinical trials was another major theme at SABCS. Patients can become disheartened by their breast cancer diagnosis. Add a failure to respond positively to the standard treatment, then layer on available clinical trial options, and patients can become overwhelmed or confused.
To counter patient disillusionment, clinical research professionals must find ways to connect with patients, their caregivers, and healthcare practitioners in a systematic way to disseminate information and recommendations for suitable clinical trials.
Addressing diversity in clinical trials
Despite all of the promising advancements in breast cancer research, progress in diversity and inclusion initiatives is still needed.
Key findings from the NATALEE trial were presented at SABCS and emphasized the importance of addressing diversity in clinical trials. Trial participants included a diverse population with early breast cancer, which ensured results could be applied across a range of demographic groups, and ultimately, provide equitable access to effective cancer treatments.
The FDA’s recent guidance to include Diversity Action Plans (DAPs) in late-phase trials indicates the growing importance of diversity and inclusion in clinical trials.
I thoroughly enjoyed my time at SABCS and found the shared enthusiasm around the recent approvals truly inspiring. Despite the progress, there is much work yet to be done. Developing therapies that are less harmful to women’s gynecological health must be prioritized, and we must focus more on prevention and early detection measures, as well as enhancing patient advocacy and diversity. It will be exciting to watch the progress in the years to come.
We can help
Connect with us to learn more about Catalyst Oncology’s experience with breast cancer trials, and how we can support your next breast cancer study.
