The Science Behind Hope: 5 Breakthrough Areas in Breast Cancer Research from 2025

Plus, find out what’s on the horizon for 2026 and beyond

2025 was a pivotal year in breast cancer research, with significant breakthroughs in risk prediction and treatment as well as progress in vaccines and other clinical trial research. Since BCRF’s beginning in 1993, we have supported years of foundational studies that enable these sorts of innovations and meaningful advancements in breast cancer research. And the progress made last year sets the stage for a promising 2026.

“We have seen the power of sustained funding for breast cancer research and how it translates into targeted treatments and innovative diagnostics,” stated Dorraya El-Ashry, BCRF’s Chief Scientific Officer. “BCRF remains committed to supporting research that builds on the progress made over the last few years into 2026 and beyond.”

BCRF-funded investigators continue to lead the charge to improve outcomes and save lives. Continued support for research is essential to accelerate discoveries, bring them to patients, and move us closer to ending breast cancer.

Here, we take a look back at 2025’s most notable developments in breast cancer research.

Next-generation meds for hormone receptor-positive breast cancer

In 2025, the FDA approved imlunestrant (Inluriyo™), a new oral selective estrogen receptor degrader (SERD) for treating hormone receptor (HR)-positive/HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Another promising oral SERD, giredestrant, received fast-track approval from the FDA as an investigational drug. Exciting results from a clinical trial led by BCRF investigator Dr. Aditya Bardia demonstrated that giredestrant had clinically significant improvement in invasive disease-free survival over the standard of care. Moreover, it showed superior benefit in preventing recurrence: a 31 percent decrease in risk of distant recurrence over standard endocrine therapy in HR-positive breast cancer, including early-stage. Dr. Bardia and his colleagues will follow these encouraging early trends toward better overall survival and fewer distant recurrences over time. While not yet approved by the FDA, giredestrant’s fast-track designation and promising clinical trial results will likely result in faster approval.

BCRF-investigator Dr. Hope Rugo led another clinical trial showing that the previously approved oral SERD elacestrant (Orderdu®), along with other targeted therapies (e.g., everolimus or abemaciclib) can overcome endocrine resistance mechanisms. Both combinations — elacestrant plus abemaciclib and elacestrant plus everolimus — showed improved progression-free survival. However, the combination with abemaciclib was particularly robust (14.3 vs. 8.3 months), regardless of ESR1 mutation status.

These breakthroughs will help expand the treatment options for patients beyond fulvestrant, the first and only SERD that was available prior to 2023. Looking ahead, giredestrant could be an option that is more effective, prevents recurrence, and is better tolerated, including for early-stage breast cancer. And the clinical trial findings with elacestrant and imlunestrant could lead to promising new primary endocrine-blocking therapies that are effective for many patients with metastatic breast cancer.

ADCs show continued success across breast cancer subtypes and disease stages

In 2025, antibody drug conjugates (ADCs) demonstrated clinically meaningful benefit across breast cancer subtypes earlier in the course of disease, showing a shift from isolated successes to a more sustainable form of treatment. New clinical data showed that ADCs can outperform conventional chemotherapy in multiple settings and also offered clearer insight into how these agents should be sequenced and how resistance emerges.

2025 brought major advances for one ADC in particular: trastuzumab deruxtecan (Enhertu®): When used as an initial treatment for metastatic HER2-positive breast cancer, Enhertu® delayed cancer growth longer than current standard therapies. Growing evidence from early-stage studies suggested that Enhertu® may benefit patients earlier in the disease course, illustrating the potential for ADCs to extend their impact beyond metastatic settings.

The approval of datopotamab deruxtecan (Datroway®) further underscored the use of ADCs in HR-positive/HER2-negative breast cancer, highlighting their expanded role beyond HER2-positive tumors. Studies in 2025 provided clearer guidance on how to sequence these therapies and revealed multiple ways tumors can become resistant—insights now shaping the development of next-generation ADCs and combination treatments. 

Revolutionary AI-driven platform shapes the future of breast cancer risk prediction

In 2025, the power of artificial intelligence entered the arena of breast cancer risk prediction: The FDA granted de novo (first-of-its-kind) authorization to Clairity Breast, the first-ever AI-powered platform that predicts a woman’s risk of developing breast cancer over the next five years—using only a standard mammogram. Developed with BCRF support, Clairity Breast is unlike current risk models, which depend on factors like age, family history, or self-reported questionnaires. Instead, it analyzes the mammogram itself, using advanced artificial intelligence to detect subtle imaging patterns in breast tissue that correlate with future cancer development, even if the mammogram appears normal to the human eye. This results in a validated five-year risk score that can guide personalized follow-up care before any sign of disease appears.

Clairity Breast now makes possible a more individualized, risk-based screening approach which has been a major focus of BCRF’s efforts to improve early detection and prevention, seizing an opportunity to intercept the disease before it takes root. For decades, mammograms have been a cornerstone of early breast cancer detection. Clairity Breast takes that legacy further, transforming a diagnostic tool into a predictive one.

In 2026, BCRF’s continued support will accelerate the rollout of Clairity Breast across the U.S., expand partnerships with leading imaging centers and health systems, and drive continued development of Clairity’s broader predictive health platform. This historic milestone is a major advancement in prevention, equity, and personalized care. 

More options for treating TNBC

In 2025, research brought about meaningful progress for people with both advanced and early-stage triple-negative breast cancer (TNBC), including those with inherited genetic mutations. For patients with advanced disease, long-term updates from the KEYNOTE-355 trial confirmed pembrolizumab (Keytruda®) plus chemotherapy as a standard first-line treatment for PD-L1-positive metastatic TNBC, showing durable improvements in overall and progression-free survival and a 27 percent reduction in the risk of death, even for some patients who had to stop chemotherapy early due to side effects.

Newer treatment combinations also continued to improve outcomes. The ASCENT-04 trial showed that pairing immunotherapy with the targeted ADC sacituzumab govitecan (Trodelvy®) delayed cancer growth longer than chemotherapy plus immunotherapy, pointing to a new and more effective option for advanced disease.

Another ADC, Datroway®, also yielded promising results in a phase 3 trial testing it as a first-line treatment for locally recurrent, inoperable, or metastatic TNBC where immunotherapy is not an option. These landmark results from 2025 could pave the way for Datroway to become a treatment option for the 70 percent of patients with TNBC for whom chemotherapy remains standard of care.

Importantly, 2025 also brought encouraging advances for patients with inherited BRCA mutations and early-stage TNBC, with the OlympiaN and TBCRC-056 studies demonstrating that PARP inhibitor-based, chemotherapy-free, or chemotherapy-minimizing regimens—either alone or combined with immunotherapy—can produce high rates of complete pathologic response. Together, these findings signal a shift toward more personalized, targeted, and potentially less toxic treatment options across TNBC—a welcome result for patients with this difficult to treat subtype.

Advancing personalized medicine: from liquid biopsy to breast cancer vaccines

Circulating tumor DNA (ctDNA), which can be detected in a liquid biopsy sample, can indicate how a breast tumor is responding to treatment, track changes in tumor burden that can be used to guide targeted treatments, and more. Reports at major cancer conferences in 2025 unveiled a landmark advancement in precision oncology: real-time ctDNA-guided treatment.  

Highly anticipated results reported from the SERENA-6 trial by BCRF investigator Dr. Nick Turner demonstrated how ctDNA surveillance may be used during treatment. By analyzing ctDNA, researchers could detect the emergence of ESR1 mutations during first-line treatment. ESR1 mutations signal that the breast cancer is changing, allowing doctors to switch a patient’s treatment to a drug that’s effective regardless of ESR1 mutation status. In SERENA-6, participants were switched to the investigational drug camizestrant, which resulted in significantly improved outcomes in patients with HR-positive/HER2-negative advanced breast cancer. It targeted emerging ESR1 mutations before clinical progression.

Results of the PHERGuide study showcased the role of ctDNA in monitoring HER2-positive breast cancer treatment to determine disease status in real time and personalize treatment accordingly. It demonstrated a significant correlation between ctDNA decrease and pathologic complete response in patients with HER2-positive early breast cancer undergoing neoadjuvant HER2-targeted therapy.

Our understanding and clinical use of ctDNA is rapidly evolving, with more and more research geared towards maximizing its utility in the clinic. In 2026, research that expands our ability to pair highly accurate diagnostics (such as ctDNA analysis) with highly effective therapies will continue, sustaining the momentum towards a new era of personalized medicine for patients with breast cancer.

Breast cancer vaccines also hold great promise. This type of immunotherapy is designed to prevent, treat, or reduce the risk of breast cancer recurrence by training the body’s immune system to recognize and attack cancer cells. Once considered a pipe dream, there are currently 15 clinical trials run by BCRF investigators and others that are testing breast cancer vaccines in the U.S., some of which are in phase 2 or 3 trials. Some notable examples include vaccines that target HER2, MUC1, a-lactalbumin, hTERT, and other proteins associated with breast cancer. Because vaccines are developed with specific targets, other studies are seeking to tailor vaccines to an individual’s breast cancer, bringing us into the realm of truly personalized breast cancer care.

We have significant reason to be hopeful that 2026 will be a banner year in breast cancer research, with continued advancements in prevention, diagnostic, and treatment efforts. Through worldwide collaboration, BCRF will continue to foster the best and most promising research. We know it will take this type of focused, dedicated effort to reach the finish line: a world without breast cancer.  

Frequently asked questions

1. How close are researchers to finding a cure for breast cancer?

While there is no single “cure” for breast cancer yet, major advances in genetics, immunotherapy, and personalized medicine are bringing us closer to more effective, less toxic treatments—and improved survival for many patients with breast cancer.

2. What are the latest technologies being developed to detect breast cancer earlier?

Innovative approaches such as AI-enhanced imaging, digital pathology, and liquid biopsies are showing promise in detecting breast cancer earlier and more accurately. AI algorithms can analyze mammograms and MRI scans to identify subtle patterns that may be missed by the human eye, while digital pathology uses advanced image analysis to improve tissue-based diagnosis. Liquid biopsies, which detect cancer-related biomarkers in blood samples, offer a minimally invasive method for early detection and disease monitoring.

3. Can metastatic (stage 4) breast cancer be cured?

Metastatic breast cancer is currently not considered curable, but treatment options continue to expand. Research is rapidly progressing in areas such as targeted therapy and immunotherapy, helping people live longer and maintain a better quality of life.

4. Is there new technology that could complement or enhance mammography?

Yes. Tools such as contrast-enhanced mammography, plus advances in MRI, molecular imaging, and blood-based detection tests are being studied to enhance current screening methods or provide alternatives for individuals at higher risk.