Editor’s Note: Over the past two decades, clinical research on breast cancer in China has achieved a remarkable transformation — from “following” international standards to “running alongside”, and even “leading” in certain areas. Chinese experts in breast oncology began by learning from global research frameworks, gradually developing a distinctively Chinese model of breast cancer treatment.
With the rise of domestic pharmaceutical innovation, Chinese researchers have completed the shift from “students” to “lecturers” on the world stage.
Given China’s unique breast cancer demographics — including a large patient base, younger age of onset, and later stage at diagnosis — Chinese research has not only enriched the global landscape of breast cancer studies but also contributed valuable “Eastern evidence”, with some results even incorporated into international clinical guidelines.
At the recent “Towards New Life – Innovation in Advanced Breast Cancer Treatment and LEONARDA Series Research Recognition Conference”, Prof. Xichun Hu from Fudan University Shanghai Cancer Center delivered a keynote speech titled “Tribute to Chinese Research and Researchers Who Have Transformed Breast Cancer Care.”
In this interview with Oncology Frontier, Prof. Hu reflects on two decades of China’s progress in breast cancer research — from imitation to innovation — and analyzes the unique advantages and outstanding performance of China’s novel drugs in clinical application.
01. Oncology Frontier:
You have witnessed and contributed to China’s 20-year journey in breast cancer research, evolving from “follower” to “peer.” How did Chinese experts build the country’s own path — the so-called “Chinese model” — while learning from international experience?
Prof. Xichun Hu: The development of a uniquely Chinese approach to breast cancer research and clinical care can be divided into several key stages:
1. The Learning and Exploration Era — Borrowing Global Evidence, Building Chinese Practice
Since the 1980s, Chinese oncologists — particularly in medical oncology — have participated in international multicenter clinical trials. During this period, we were in the “learning” phase. Pioneers such as Academician Sun Yan and Prof. Guan Zhongzhen led efforts to adopt and refine international clinical trial methodologies.
For instance, we introduced the RECIST criteria for tumor response evaluation and the CTCAE system for adverse event assessment, aligning with global standards while continuously improving them to suit local practice.
Through participation in global trials, Chinese clinicians gained a deep understanding of standardized clinical trial operations, laying the foundation for China’s independent research capabilities.
2. From Following to Running Alongside — Developing Chinese Solutions Based on Global Advances
Entering the 21st century, as China’s domestic drug innovation capacity strengthened, Chinese researchers began to design and lead studies addressing key local clinical challenges.
I often remind young doctors:
“If we rely solely on imported drugs, without developing our own, our contribution to global oncology will remain limited.”
The emergence of homegrown innovative drugs marked a turning point for Chinese breast cancer research, with multiple studies now recognized on the global stage.
For example, in 2017, the Journal of Clinical Oncology (JCO) published the first phase I study of pyrotinib, a novel anti-HER2 agent developed in China, led by Prof. Binghe Xu of the National Cancer Center. Subsequent phase II and III results were published in top international journals, demonstrating that Chinese investigators can conduct high-quality, multicenter clinical trials to global standards.
Similarly, the CBCSG006 phase III trial (2014), jointly conducted by Fudan University Shanghai Cancer Center and the National Cancer Center, confirmed the superiority of cisplatin plus gemcitabine as first-line therapy for advanced triple-negative breast cancer. This study established a “China protocol” that gained international recognition and provided a new treatment option for TNBC patients worldwide.
02. Oncology Frontier:
How has China’s rapid progress in breast cancer research influenced global clinical practice and understanding in recent years?
Prof. Xichun Hu: Chinese breast cancer patients exhibit several distinct characteristics compared with Western populations:
- Large population base: A vast number of new cases each year places a significant burden on healthcare systems.
- Younger onset: A higher proportion of premenopausal patients, which allows Chinese research to contribute a more comprehensive evidence base across all age groups.
- Later diagnosis: Many patients present at more advanced stages, highlighting the need for better early detection strategies.
Through large-scale clinical research, China has generated evidence that not only updates national guidelines but also reshapes international recommendations, reflecting global recognition of Chinese studies.
In recent years, China’s evolution from a follower to a global contributor stems from two major factors:
- Improved scientific and technical expertise among Chinese oncologists, and
- Rapid growth in domestic pharmaceutical R&D.
I often use the term “breast oncologist” to describe the modern multidisciplinary Chinese expert — including medical, surgical, and radiation oncologists — all contributing to China’s research-driven innovation.
Today, at international conferences like ASCO, ESMO, and SABCS, Chinese experts no longer just sit in the audience — they are on stage as speakers. This transition from listening to teaching represents not only progress but also the growing academic authority and influence of Chinese oncology on the global stage.
03. Oncology Frontier:
You mentioned that Chinese investigators have led numerous CDK4/6 inhibitor studies, including your role as Leading PI of the LEONARDA-2 trial. Could you elaborate on the mechanism and clinical profile of Lerociclib, this novel CDK4/6 inhibitor?
Prof. Xichun Hu: In developing CDK4/6 inhibitors, we have carefully evaluated the structure, efficacy, and safety of each agent to find the optimal balance between therapeutic benefit and tolerability.
Although no direct head-to-head comparison between Lerociclib and other CDK4/6 inhibitors has been conducted yet, existing data suggest that Lerociclib exhibits superior overall performance in both efficacy and safety.
From a clinician’s standpoint, efficacy remains the most critical endpoint. The LEONARDA-1 study, published in Nature Communications, provided robust evidence for second-line treatment of HR+/HER2– advanced breast cancer: Lerociclib plus fulvestrant significantly improved progression-free survival (PFS) compared to placebo plus fulvestrant — 11.07 months vs 5.49 months (HR=0.451, 95% CI: 0.311–0.656, P=0.000016).
The LEONARDA-2 study, which enrolled previously untreated HR+/HER2– advanced breast cancer patients, was presented at the 2024 ASCO Annual Meeting. Results demonstrated a 54% reduction in disease progression risk, with median PFS not reached in the Lerociclib arm versus 16.56 months in the control arm (HR=0.464, 95% CI: 0.293–0.733, P=0.0004).
Across both studies, Lerociclib maintained low rates of hematologic toxicity, thromboembolism, and interstitial lung disease, reinforcing its favorable safety profile.
Taken together, these data confirm that Lerociclib is a highly promising next-generation CDK4/6 inhibitor — offering both efficacy and safety advantages. We look forward to further evidence supporting its use as a reliable and effective option for patients.
Conclusion
China’s achievements in breast cancer research have been extraordinary. In the early years, by adopting and adapting Western evidence-based medicine, Chinese clinicians established a foundation for standardized breast cancer management.
Over time, China not only kept pace with international standards but also began to shape global practices, with multiple Chinese-led studies now incorporated into both domestic and international guidelines.
Most importantly, China’s emphasis on independent innovation — powered by science and technology — has ushered in a new era where “Chinese innovation” contributes meaningfully to global oncology.
From careful accumulation to confident advancement, and now to distinct leadership, Chinese breast cancer research continues to break new ground, offering hope to patients and demonstrating the strength of Chinese scholarship on the global stage.
In the future, China will continue to contribute more Eastern wisdom and strength to the fight against breast cancer worldwide.
Prof. Xichun Hu
Professor, Doctoral Supervisor Fudan University Shanghai Cancer Center
