In recent years, clinical research in China’s breast cancer field has made significant strides, particularly in the area of new drug clinical research. A series of groundbreaking studies have been published, exerting a substantial impact on the international breast cancer treatment landscape. At the 2025 South-North Summit, Professor Binghe Xu, Academician at the Cancer Hospital Chinese Academy of Medical Sciences, delivered a lecture on "Advances and Outlook of Breast Cancer Drug Clinical Research in China," providing a detailed overview of clinical research developments in HR+, HER2+, and triple-negative breast cancer. Following the conference, Oncology Frontier interviewed Academician Xu, who discussed the evolving status of Chinese breast cancer clinical research on the international stage, the key topics of the SGBCC Early Breast Cancer Consensus Voting, and the future directions of China’s breast cancer clinical research.Oncology Frontier: At this conference, you gave a lecture titled “Advances and Outlook of Breast Cancer Drug Clinical Research in China.” Could you summarize your lecture and share the key developments in clinical research in China’s breast cancer field in recent years?
Academician Binghe Xu: Over the past decade, clinical research in China’s breast cancer field, particularly in the development of new drugs, has advanced rapidly. In the past, we mainly participated in or followed international multi-center clinical trials. However, in recent years, we have made significant breakthroughs, publishing a series of original research findings that have had a substantial impact both internationally and domestically. These advancements can be summarized in the following areas:
Hormone Receptor-Positive (HR+) Breast Cancer
Previously, endocrine treatment for HR+ breast cancer focused on sequential therapy, meaning one endocrine therapy drug would be replaced by another when it became ineffective. The advent of CDK4/6 inhibitors has revolutionized the treatment landscape. We led the first domestic Phase III clinical trial of the CDK4/6 inhibitor, Darolacilib (DAWNA-1 study). The interim analysis successfully met the primary endpoint, showing that Darolacilib combined with Fulvestrant significantly improved progression-free survival (PFS) compared to placebo plus Fulvestrant (HR = 0.42). The results were officially published in Nature Medicine. Building on this, we conducted the DAWNA-2 study, evaluating Darolacilib as first-line therapy. This study showed that combining Darolacilib with standard non-steroidal aromatase inhibitors, letrozole or anastrozole, was more effective than monotherapy. The results were published in Lancet Oncology. This study not only changed domestic clinical guidelines but was also recognized as one of the top ten medical clinical research advancements in China in 2023.
Additionally, we’ve conducted studies aimed at overcoming resistance to CDK4/6 inhibitors, such as combining HDAC inhibitors and mTOR inhibitors with aromatase inhibitors. Our MIRACL study demonstrated that Everolimus combined with letrozole extended PFS in premenopausal patients. The ACE study showed that the combination of Belinostat and the steroidal aromatase inhibitor Exemestane was more effective than Exemestane alone. These findings have expanded treatment options for HR+ metastatic breast cancer and transformed clinical practice.
HER2-Positive Breast Cancer
In the field of HER2-positive breast cancer treatment, Chinese researchers have conducted numerous studies on small-molecule tyrosine kinase inhibitors (TKIs), such as Pyrotinib. The PHENIX study demonstrated that for patients who failed taxane and trastuzumab treatment, Pyrotinib combined with capecitabine significantly improved PFS and overall response rate (ORR) compared to capecitabine alone. Even after disease progression, patients who continued with Pyrotinib showed benefits. The PHOEBE study showed that Pyrotinib plus capecitabine was superior to Lapatinib plus capecitabine in terms of PFS, with a trend toward improved overall survival (OS). These results have been presented multiple times at international conferences.
In the first-line treatment of HER2-positive metastatic breast cancer, trastuzumab plus docetaxel is the standard single-target therapy. Our PHILA study, a nationwide, randomized, double-blind, placebo-controlled Phase III trial, compared Pyrotinib plus trastuzumab and docetaxel (PyroHT group) with placebo plus trastuzumab and docetaxel (HT group). The results confirmed that the combination of small and large molecules was significantly more effective than trastuzumab plus chemotherapy. The median PFS for the PyroHT group and HT group was 22.1 months and 10.5 months, respectively (HR = 0.44, 95% CI: 0.36-0.53; P<0.0001), representing the longest PFS reported for first-line treatment of advanced HER2-positive breast cancer. These findings were published in The British Medical Journal in 2023. Pyrotinib’s research in both second-line and first-line settings has been incorporated into the 7th edition of the international advanced breast cancer guidelines (ABC), gaining recognition from the global medical community. Currently, dual-antibody drugs and antibody-drug conjugates (ADC) are being studied for use in first-line, second-line, post-surgery adjuvant, and neoadjuvant treatments. The results are eagerly anticipated and could further expand treatment options for Chinese breast cancer patients.
Triple-Negative Breast Cancer (TNBC)
We were among the first in China to conduct studies on platinum-based chemotherapy for triple-negative breast cancer, confirming that platinum-based drugs are superior to traditional chemotherapy for first-line treatment of advanced TNBC. Domestic colleagues have also verified the importance of platinum drugs in the neoadjuvant and adjuvant settings, particularly in BRCA1/2 mutation carriers, where the efficacy is even better.
Currently, TNBC research is increasingly focused on immunotherapy and ADCs. The TORCHLIGHT study, led by Chinese researchers, demonstrated that Toripalimab combined with albumin-bound paclitaxel as a first-line treatment for PD-1 positive advanced TNBC provided significant survival benefits. The study results were published in Nature Medicine. Immunotherapy’s role in first-line and neoadjuvant treatment for TNBC is becoming clearer, although its efficacy varies depending on the chemotherapy drugs combined and the type of PD-1/PD-L1 inhibitor used. The administration method also impacts the effectiveness of immunotherapy. Furthermore, the side effects of immunotherapy, such as myocarditis, nephritis, and hypothyroidism, should be closely monitored. Domestic researchers must pay attention to these adverse effects during clinical trials.
China’s research on ADCs primarily targets Trop-2, with the SKB264 (Liraglutide-Satuximab) Phase III OptiTROP-Breast01 study demonstrating that SKB264 significantly improves PFS and OS compared to chemotherapy chosen by the doctor. The study results were presented at the 2024 ASCO Annual Meeting and will soon be published in an international journal.
Overall, there has been remarkable progress in China’s clinical research on new breast cancer drugs in recent years. As new drugs continue to emerge, future research will focus on discovering new breast cancer targets, developing innovative drugs targeting these targets, optimizing treatment regimens, identifying biomarkers to predict efficacy and safety, and conducting multi-center clinical trials. We hope domestic researchers will strengthen collaborations and bring more Chinese-made drugs to the global market.
Oncology Frontier: You and your team have made remarkable achievements in clinical research on breast cancer, such as the DAWNA series, LEONARDA-1 study, and MIRACLE study. These studies have not only had a significant impact domestically but also gained widespread recognition internationally. How do you view the position and role of China’s breast cancer clinical research on the global stage? Looking ahead, how can China further enhance its contribution and influence in the global breast cancer research field?
Academician Binghe Xu: The influence of China’s breast cancer research on the international stage is gradually increasing. At international academic conferences, global peers are well aware of and highly interested in the research we’ve led, particularly studies related to Pyrotinib. Currently, countries like India and South Korea are conducting studies on this drug, and Japan may also begin related research in the future. Given the similarities in the Asian population, international colleagues believe that drugs effective in treating Chinese patients may also work well in other Asian countries. As a result, China’s original research findings are drawing significant attention internationally, with these results being incorporated into international guidelines, which has deepened global recognition of Chinese research.
As China’s research continues to advance, our voice on the international stage is becoming stronger. For example, at this year’s St. Gallen International Breast Cancer Conference (SGBCC), the Chinese expert delegation included Professor Yin Yongmei as the female representative, bringing the total number of experts to five (including one representative from Taiwan, China). This increase highlights China’s growing influence in global innovative drug development and academic leadership, earning high recognition from international peers.
We are particularly excited about the upcoming SGBCC conference. On the one hand, it is an opportunity to reunite with old friends and meet new international colleagues and friends. On the other hand, we look forward to hearing more research progress from China at the conference. Our team’s young doctors have won the SGBCC Poster Award and have been invited to give presentations, demonstrating the conference’s recognition of young doctors. Additionally, at this conference, our expert team not only participated in the early breast cancer consensus voting but also took part in the organizing and reporting sessions. This further confirms that China’s position in breast cancer academia is increasingly acknowledged by international peers, and we look forward to more exciting developments in future conferences.
Oncology Frontier: As an expert participating in the early breast cancer consensus voting at the SGBCC, could you share your thoughts on the issues that you find particularly concerning?
Academician Binghe Xu: Currently, the areas of focus in the consensus voting mainly concentrate on three major aspects: surgery, radiotherapy, and medical treatment. These are broad categories. Additionally, there are smaller yet significant topics worth addressing, such as pathology diagnostics and genetic testing. On genetic testing, I am particularly interested in whether it is necessary to conduct genetic testing for all breast cancer patients after diagnosis. I hope to understand the views of international colleagues on this issue.
For example, with regard to BRCA1/2 genetic testing, should all breast cancer patients undergo this testing? Would the results potentially have negative consequences? There are many ethical, privacy, and legal considerations to explore. For instance, if a minor with a family history of breast cancer tests positive, it could have lifelong impacts, including psychological consequences and possible discrimination in future employment or insurance applications. These issues are crucial and warrant broad attention. Through this voting, I aim to gauge the consensus on genetic testing.
Moreover, in drug treatment, there is also discussion about the use of anthracyclines. In the era of dual-target therapies and the increasing application of ADC drugs, should we consider removing anthracyclines from treatment regimens? This was a past perspective, but it now needs to be revisited and discussed. I look forward to hearing others’ views on this through the consensus voting.
Regarding postoperative adjuvant therapy indications, there are differences between China and Western countries. In general, the approach in Europe and the U.S. is more conservative, while the standards in China tend to be more inclusive. For example, in China, patients with any lymph node metastasis are typically required to undergo postoperative adjuvant therapy, whereas in Western countries, patients with negative axillary lymph nodes may undergo gene tests like the 21-gene or 70-gene tests, and high-risk patients will receive chemotherapy, but low- to medium-risk patients may not necessarily receive chemotherapy. Now, for patients with 1–3 positive lymph nodes, the decision to administer chemotherapy is also being considered, with low-risk patients often not requiring chemotherapy. Whether this view is widely accepted is another issue I am concerned about.
For HER2-positive breast cancer, there are some common clinical concerns, such as whether patients with multifocal tumors of 2–3 millimeters need anti-HER2 treatment. In radiotherapy, with the continuous emergence of new technologies, which patients should receive dose-escalated radiotherapy, who should receive standard radiotherapy, and who might be exempt from radiotherapy? These are contentious issues that deserve attention.
In the field of surgery, we are also interested in which patients can be exempted from axillary lymph node dissection. In China, the common practice is that any patient with positive axillary lymph nodes, whether with macro- or micro-metastasis, undergoes lymph node dissection. However, in some countries, certain patients can be exempted from axillary dissection.
Through this voting, I hope to understand the perspectives of international colleagues on surgery, radiotherapy, and medical treatment, which will help drive progress in breast cancer treatment and research.
