What’s New in Breast Cancer
This section gives an overview of new breast cancer treatment breakthroughs and recent developments in research that are fueling new ways to assess risk, and prevent, detect, diagnose and treat breast cancer. Advances in breast cancer care are evaluated through a rigorous process that includes clinical trials and regulatory approvals before being considered standards of care and included in breast cancer care guidelines. Komen’s research team monitors the rapidly evolving breast cancer landscape, and here we will highlight new breast cancer treatment breakthroughs, innovations in technology or key advances that may be added or are new to guidelines. We will share these research advancements to empower patients with knowledge to help them make informed decisions with their doctors.
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Treatments and Drugs
For patients, new treatments can mean more options and more hope. Researchers are working to develop new breast cancer treatment breakthroughs, such as more effective drugs that will specifically target breast cancer cells, minimize side effects and prevent breast cancer cells from coming back. While some treatments increase the effectiveness of existing drugs, others may offer new, innovative strategies for attacking tumor cells.
As of August 2023, the following new treatments and drugs are currently in clinical trials and have not yet received FDA approval:
- Datopotamab deruxtecan (Dato-DXd): A new TROP2-targeting antibody-drug conjugate
- A new antibody-drug conjugate called datopotamab deruxtecan (Dato-DXd) is currently being evaluated in three Phase 3 clinical trials for advanced estrogen receptor-positive (ER+)  breast cancer, metastatic triple negative  breast cancer and early triple negative  breast cancer (TNBC). Dato-DXd specifically targets a protein called TROP2, a biomarker that can be used to target cancer cells instead of healthy cells. Another TROP2-targeting therapy called sacituzumab govitecan has already been approved for TNBC and estrogen-receptor-positive breast cancer. Dato-DXd uses a different chemotherapy drug and delivery system compared to sacituzumab govitecan.
- Patritumab deruxtecan (HER3-DXd): An emerging antibody-drug conjugate targeting HER3
- HER2 is a common treatment target for breast cancer. This new drug targets HER3, a biomarker related to HER2, which is associated with poor breast cancer outcomes. About 10% to 20% of newly diagnosed breast cancers are HER2-positive. At the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, researchers announced positive results for a Phase 2 clinical trial studying HER3-DXd, a new HER3-targeting antibody-drug conjugate for people with metastatic breast cancer. . While the study found that 35% of patients responded positively to HER3-DXd, researchers will continue to evaluate which patients could benefit most from this drug through future Phase 3 clinical trials.
- Trilaciclib – A new CDK4/6 inhibitor being tested in TNBC
- CDK4/6 inhibitors are commonly used to treat estrogen receptor-positive breast cancer, but a new CDK4/6 inhibitor called trilaciclib is being tested to treat TNBC. Results from a Phase 2 clinical trial showed that trilaciclib improved outcomes for people with advanced TNBC, and the drug is currently being evaluated in the Phase 3 PRESERVE 2 clinical trial . Researchers believe that unlike currently available CDK4/6 inhibitors, trilaciclib may improve response to immunotherapy and mitigate some of the side effects of chemotherapy. If this clinical trial is successful, this would be the first CDK4/6 inhibitor approved for people with TNBC.
- Cerianna (Fluoroestradiol F-18) – A diagnostic imaging agent to detect estrogen-receptor (ER) positive breast cancer metastases
- Doctors may use PET scans, or positron emission tomography, to scan for evidence that breast cancer has spread or metastasized. Once breast cancer has spread, the metastases may have evolved to a different type of breast cancer than the original tumor. These differences mean the metastases and the original tumor may not respond to the same treatments. A diagnostic imaging agent called Cerianna (fluoroestradiol F-18 or FES PET) allows doctors to use PET scans to learn if estrogen receptors are present in metastatic lesions. If a person has metastatic lesions that are estrogen receptor-positive, they may respond well to hormone therapy. This agent was recently incorporated in the National Comprehensive Cancer Network (NCCN) guidelines  as an option for some people with metastatic or recurrent estrogen receptor-positive breast cancer to consider .
- Breast Cancer Index – A test to personalize treatment for ER-positive breast cancer
- Ovarian suppression increases the effectiveness of hormone therapy in some premenopausal women but comes with additional side effects that can affect quality of life. A study presented at the 2022 San Antonio Breast Cancer Symposium  suggests that the Breast Cancer Index, a tumor profiling test that looks at genes to predict how likely a cancer is to metastasize, may be able to identify premenopausal women that would benefit most from ovarian suppression. This test would give doctors a new tool to personalize treatment for premenopausal women with estrogen receptor-positive breast cancer. More data are needed to confirm these results.
- HER2DX – A test to personalize treatment for HER2-positive breast cancer
- Doctors are getting closer to identifying which patients with early HER2-positive breast cancer can safely avoid chemotherapy by using the HER2DX genomic test. HER2DX is the first test specifically designed to identify HER2-positive patients at high and low risk for recurrence. For some people, being able to avoid chemotherapy without comprising long-term outcomes will lead to a better quality of life.
Approaches to Care
With knowledge gained from clinical trials, researchers are seeking new ways to improve patient outcomes while using existing drugs. Some new breast cancer treatment breakthroughs are the result of combining certain drugs, finding which patients can skip certain elements of treatment or changing the order of their treatments to maximize effectiveness or minimize side effects.
- Early estrogen receptor-positive breast cancer – A new approach to stop breast cancer from coming back
- Patients with early estrogen receptor-positive breast cancer generally have a good prognosis, but some people have a higher risk of recurrence for as long as 20 years. Researchers are seeking new strategies to reduce this risk of recurrence. CDK4/6 inhibitors are used to treat advanced breast cancer, but the Phase 3 NATALEE clinical trial, presented at the 2023 American Society of Clinical Oncology Annual Meeting , found that using the CDK4/6 inhibitor ribociclib for two years in the adjuvant setting reduced the risk of recurrence for people with estrogen receptor-positive breast cancer.
- Inflammatory breast cancer diagnostic tool – A new tool for diagnosing an aggressive breast cancer
- Inflammatory breast cancer is difficult to diagnose because its symptoms often mimic infections. Additionally, because some medical professionals don’t see it often, they may lack experience in recognizing and treating inflammatory breast cancer. In partnership with the Inflammatory Breast Cancer Research Foundation and the Milburn Foundation, Susan G. Komen launched a first-of-its kind diagnostic tool for inflammatory breast cancer. Through this scoring system, the tool considers the defining features of inflammatory breast cancer and provides data that can help providers accurately determine whether a person has inflammatory breast cancer. The goal of this tool is to increase the accuracy of diagnosing inflammatory breast cancer so that people will receive the appropriate care they need to treat this aggressive disease.
- Immunotherapy – A new option for estrogen receptor-positive breast cancer
- Immunotherapy targets the immune system to help the body fight off tumors. Immunotherapy is currently only available for some patients with triple negative breast cancer, but researchers are aiming to bring this cutting edge therapy to more people. In a recent announcement , positive results were announced for a clinical trial that evaluated the immunotherapy drug pembrolizumab in patients with early estrogen receptor-positive breast cancer. Komen will be closely monitoring the results of this study at upcoming scientific conferences and hopes to see more promising data suggesting that a new treatment option may soon be available for patients with early estrogen receptor-positive breast cancer.
- A new chemotherapy schedule to decrease side effects and improve quality of life
- Clinical trials are often designed using the maximum tolerated dose of a drug. However, many drugs may give the same effect with a smaller dose that results in fewer side effects for the patient. The X-7/7 clinical trial, which was presented at the 2023 ASCO Annual Meeting, tested the impact of a new treatment schedule for the chemotherapy drug capecitabine to treat metastatic breast cancer. Researchers found that people who took a higher dose of capecitabine over fewer days had fewer side effects and were able to remain on their treatment longer compared to the standard regimen. This new approach can improve the quality of life for those living with metastatic breast cancer without compromising the effectiveness of their treatments.
Komen will be closely monitoring the results of these studies and more at upcoming scientific conferences and hopes to see more promising data regarding new ways to prevent, detect, diagnose and treat breast cancer.
Help discover cures to breast cancer, faster.
New treatment breakthroughs for breast cancer come from researchers learning from people who have breast cancer, but our current data sources only represent a small portion of the breast cancer community. Help us discover the cures to breast cancer, faster, by joining ShareForCures.
What’s New in Breast Cancer References
- Hamilton, E. P., et al. (2023). “A phase 2 study of HER3-DXd in patients (pts) with metastatic breast cancer (MBC).” Journal of Clinical Oncology 41(16_suppl): 1004-1004. https://meetings.asco.org/abstracts-presentations/219699
- Stroyakovskiy, D., et al. (2023). “Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial.” Journal of Clinical Oncology 41(17_suppl): LBA500-LBA500.