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.
Use these links to jump to the topics below.
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+) [1] breast cancer, metastatic triple negative [2] breast cancer and early triple negative [3] 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.
- Lasofoxifene: A potential new hormone therapy targeting ESR1 mutations in breast cancer
- People with metastatic estrogen receptor-positive breast cancer that progresses after their initial treatment are prone to developing mutations in the estrogen receptor (ER) gene (ESR1)[4]. ESR1 mutations cause the ER protein to be constantly active, driving tumor growth even in the presence of drugs designed to stop the ER from working. Lasofoxifene is a new type of hormone therapy being studied that stops the ER even when it’s mutated. Recent findings from the phase 2 ELAINE 2 clinical trial showed lasofoxifene plus the CDK4/6 inhibitor abemeciclib resulted in participants’ cancer remaining stable for a median of 13 months. Based on these results, the new phase 3 ELAINE 3 trial will compare lasofoxifene with the current standard of care fulvestrant (hormone therapy) in combination with a CDK4/6 inhibitor. If successful, patients may have a new hormone therapy option.
- Durvulamab + Dato-DXd: A potential novel drug combination for triple negative breast cancer (TNBC)
- Pembrolizumab is currently the only immunotherapy drug available for people with TNBC. The phase 2 BEGONIA clinical trial recently reported promising results for an immunotherapy drug called durvalumab (Imfinizi) in combination with a TROP-2 targeting antibody-drug conjugate being studied called Dato-DXd [5]. In this clinical trial, 62 people with metastatic triple-negative breast cancer were treated with this novel drug combination, and their cancer remained stable for a median of 13.8 months. Based on these exciting results, there are now three phase 3 clinical trials testing this drug combination in different breast cancer settings (TROPION-Breast03, TROPION-Breast04, TROPION-Breast05).
Technology
New and improved technologies may be able to increase the speed and accuracy of detecting, diagnosing or monitoring breast cancer for progression and response to treatment.
- 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 [6] as an option for some people with metastatic or recurrent estrogen receptor-positive breast cancer to consider [7].
- Targeting hibernating cancer cells
- Dormant cancer cells are cells that did not die from a person’s initial treatment. These cells can “hibernate” undetected for unknown reasons until they begin to grow again. The bone is a common place for dormant breast cancer cells to hide and possibly grow. In the phase 2 CLEVER clinical trial [8], presented at the European Society of Clinical Oncology in October 2023 by Komen Scholar Dr. Angela DeMichele, researchers tested whether they could find dormant cancer cells in participants’ bone marrow and eliminate them. Study results showed researchers were able to find and remove dormant cancer cells from about 80% of the participants. While larger studies will be needed to confirm these results, the CLEVER study shows this promising approach may prevent breast cancer recurrence.
- 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 compromising 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.
- New immunotherapy approach in early triple negative breast cancer (TNBC)
- All people with early TNBC are currently treated with immunotherapy and chemotherapy prior to surgery, then they receive immunotherapy for up to 27 weeks after their surgery. A new phase 3 clinical trial called OptimICE-PCR led by Komen Scholar Dr. Sara Tolaney, will test a new approach. The study will determine whether simply observing patients is as effective as getting immunotherapy after surgery in preventing breast cancer from coming back, if their initial treatment successfully got rid of all the breast cancer [9]. While effective, immunotherapy comes with side effects and may not be needed in some treatment plans. This study will help identify who can safely de-escalate their immunotherapy treatment while maintaining good outcomes.
- More patients may benefit from trastuzumab deruxtecan (Enhertu)
- Results from the phase 3 DESTINY-Breast06 clinical trial [10], presented at the American Society of Clinical Oncology (ASCO) meeting in June 2024, showed patients with metastatic estrogen receptor-positive (ER-positive), HER2-low and HER2-ultralow breast cancer had about a 5-month progression-free survival benefit with trastuzumab deruxtecan compared to chemotherapy. HER2-ultralow is a new designation and means that there is a very small amount of detectable HER2 in a tumor. Trastuzumab deruxtecan has already been shown to be effective in HER2-low metastatic breast cancer, but this is the first study showing that people with HER2-ultralow metastatic breast cancer may benefit as well. With these new findings, about 85% of patients with metastatic ER-positive breast cancer may become eligible for this treatment.
- New insights into pregnancy after breast cancer
- New data from the Young Women’s Breast Cancer Study, led by Komen Chief Scientific Advisor Dr. Ann Partridge, found 73% of women with stage I-III breast cancer who attempted to get pregnant after completing their breast cancer treatment were successful. [11] This study, presented at the 2024 Annual ASCO meeting, is one of the most comprehensive studies attempting to answer this question to date. The results highlight the importance of making sure women have access to fertility preservation when they begin their breast cancer treatment.
- Personalizing chemotherapy for Black women
- Komen Scholar Dr. Bryan Schneider conducted the phase 2 EAZ171 clinical trial, which tested whether certain gene mutations could predict the likelihood of developing a side effect from some types of chemotherapy called taxane-induced peripheral neuropathy (TIPN), which is more common among Black women. This side effect causes pain, numbness and tingling in the extremities and can also lead to the treatment being stopped. Komen grantee Dr. Tarah Ballinger presented the results of the EAZ171 study at the 2024 Annual ASCO meeting. [12] The study found that while the gene mutations were unable to predict the likelihood of developing TIPN, researchers did identify a chemotherapy regimen that resulted in fewer instances of TIPN. These results provide some of the best evidence available to date to personalize chemotherapy treatment for Black women.
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.
![](https://www.komen.org/wp-content/uploads/ShareForCures_Logo.png)
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
- https://classic.clinicaltrials.gov/ct2/show/NCT05104866
- https://clinicaltrials.gov/study/NCT05374512
- https://classic.clinicaltrials.gov/ct2/show/NCT05629585
- https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-021-01462-3
- https://oncologypro.esmo.org/meeting-resources/esmo-congress/datopotamab-deruxtecan-dato-dxd-durvalumab-d-as-first-line-1l-treatment-for-unresectable-locally-advanced-metastatic-triple-negative-breast
- https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-announces-fes-pet-imaging-recommendation-in-nccn-clinical-practice-guidelines-in-oncology-nccn-guidelines
- https://www.nccn.org/patients/guidelines/content/PDF/breast-invasive-patient.pdf (page 16)
- https://ascopost.com/news/october-2023/novel-strategies-for-eliminating-dormant-tumor-cells-in-breast-cancer-survivors/
- https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-07859&r=1
- https://ascopost.com/news/june-2024/t-dxd-improves-progression-free-survival-in-patients-with-breast-cancer-previously-treated-with-endocrine-therapy/
- https://www.dana-farber.org/newsroom/news-releases/2024/most-young-women-treated-for-breast-cancer-can-have-children-study-shows#:~:text=Most%20young%20women%20treated%20for%20breast%20cancer%20can%20have%20children%2C%20study%20shows,-Posted%20date&text=New%20research%20by%20Dana%2DFarber,and%20want%20to%20have%20children.
- https://www.komen.org/blog/personalized-chemo/