The 19th St. Gallen Breast Cancer Conference (SGBCC 2025) took place from March 12–15, 2025, in Vienna—the world-renowned capital of music. A major highlight of the event was the “Voice of China” session, where international experts gathered to exchange insights on the development of innovative therapies from China. On this occasion, Oncology Frontier sat down with Dr. Man Li from The Second Hospital of Dalian Medical University to discuss the key drivers enabling innovative drugs to shift from late-stage to early-stage breast cancer, and to explore how Chinese innovations are increasingly shaping global clinical practice.Oncology Frontier: This year’s SGBCC opened with an academic discussion on the advancement of anti-tumor therapies from late-stage to early-stage breast cancer. In this process, how can we best support patients on their path toward a potential cure?
Dr. Man Li: In recent years, breast cancer treatment has progressed at an unprecedented pace, with a constant stream of innovative therapies emerging. We’ve observed a clear trend: drugs that demonstrate efficacy in advanced breast cancer are now making their way into the early-stage setting, with increasingly impactful outcomes.
In targeted therapy, the combination of trastuzumab and pertuzumab (dual anti-HER2 therapy) achieved significant PFS and OS benefits in the CLEOPATRA study. Building on this, the APHINITY trial demonstrated encouraging outcomes with the same dual-targeted regimen in early-stage HER2-positive breast cancer, offering hope for a cure in this population.
The antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1) has also transitioned from advanced to early-stage settings. Specifically, in patients who did not achieve a pathologic complete response (non-pCR) after neoadjuvant therapy, T-DM1 has shown improvement in invasive disease-free survival (iDFS), leading to meaningful short-term benefits.
Emerging CDK4/6 inhibitors have shown strong PFS—and in some cases OS—benefits in advanced HR+/HER2− breast cancer, and are now expanding into the early-stage arena. The NATALEE and monarchE studies have demonstrated iDFS improvement with ribociclib and abemaciclib, respectively, laying a foundation for adjuvant intensification in intermediate- and high-risk early-stage HR+/HER2− breast cancer.
In terms of immunotherapy, patients with advanced triple-negative breast cancer (TNBC) have already benefited in terms of both PFS and OS. The KEYNOTE-522 trial further showed that combining immunotherapy with chemotherapy in the neoadjuvant setting for early TNBC can improve pCR, event-free survival (EFS), and OS, marking a major step toward bringing immunotherapy into early breast cancer management.
At this year’s SGBCC, new data suggested that in early HR+ breast cancer with Grade 3 tumors, intermediate or low ER expression, high tumor-infiltrating lymphocytes (TILs), and PD-L1 positivity, immunotherapy may improve short-term treatment outcomes. While further follow-up is needed to confirm long-term benefits, especially regarding OS, these findings open up an exciting new frontier in early-stage HR+ breast cancer care.
Oncology Frontier:Innovative drug development often follows a progression from late-line to frontline settings, and from advanced to early-stage disease. Could you elaborate on the necessity of this pathway, and what the key factors are for a drug to move from late-stage to early-stage breast cancer?
Dr. Man Li: More and more therapies that have demonstrated benefit in advanced breast cancer are now being investigated in early-stage settings, and the single most important factor driving this transition is efficacy. As mentioned earlier, large-molecule targeted therapies, antibody-drug conjugates (ADCs), CDK4/6 inhibitors, and immunotherapies all first demonstrated improvements in PFS or even OS in the advanced setting, which then paved the way for exploration in early breast cancer, where they have also shown improvements in invasive disease-free survival (iDFS).
Safety is another critical factor. Since early breast cancer treatment is often aimed at curative intent, the long-term safety of any drug becomes paramount. A therapy associated with high toxicity may not gain traction in this space. Thus, for a novel therapy to successfully expand into early-stage disease, it must deliver both efficacy and safety.
In addition, the design of clinical trials is crucial. Trials in early breast cancer typically require larger sample sizes and longer follow-up durations, making study design all the more important. For example, identifying enriched populations most likely to benefit when translating a therapy from advanced to early-stage disease is a key consideration.
Looking ahead, we hope to see more robustly designed clinical studies that will bring highly effective and safe innovative drugs into earlier stages of care, ultimately enabling more patients to achieve a cure.
Oncology Frontier: China’s innovative drug landscape is rapidly evolving, offering more treatment options for breast cancer patients both domestically and globally. Could you share your perspective on how Chinese-developed therapies are changing the future of breast cancer care?
Dr. Man Li: In recent years, we’ve witnessed a surge in innovative drug development in the breast cancer field. China’s journey from generic drug production to original innovation has been long and challenging, but it is now showing real momentum.
We’ve already seen tremendous clinical benefit from biosimilars and generics, such as trastuzumab biosimilars developed by Henlius, and trastuzumab, pertuzumab, and palbociclib generics from Chia Tai Tianqing, which have delivered effective outcomes at significantly lower costs, making treatment more accessible to Chinese patients.
At the same time, many domestic pharmaceutical companies are shifting from generics to true innovation. For example, pyrrotinib, a first-in-class drug from Hengrui, has demonstrated strong efficacy in HER2-positive advanced breast cancer. Chia Tai Tianqing is also building an expansive innovation pipeline, with agents under development including CDK2/4/6 inhibitors, HER2-targeting ADCs, HER2 bispecific antibodies, PAM pathway inhibitors, and PROTAC-based therapies. These efforts represent hope for Chinese patients with breast cancer in the years to come.
Chinese innovative drugs are also making strides internationally, with more global multicenter trials underway and growing international recognition. At this year’s SGBCC “Voice of China” session, many global experts agreed that China should take the lead in initiating international studies, inviting broader participation to foster deeper understanding of China’s advancements.
Going forward, raising the quality standards of our own innovative therapies will be essential. These drugs must serve not only Chinese patients, but also meet global benchmarks, ultimately changing clinical practice and making their way into international guidelines and consensus documents.
I believe that as international collaboration continues to deepen, China’s voice in oncology will grow stronger, and our homegrown innovations will increasingly shape the future of global cancer care.
Dr. Man Li
- MD, Professor, Doctoral Supervisor
- Director, Department of Oncology; Director, Teaching and Research Division The Second Hospital of Dalian Medical University
- Director, Phase I Clinical Trial Ward
- Distinguished Professor of Liaoning Province
- Member, “Hundred Talents Program” (Top Tier), Liaoning Province
- Executive Council Member, Chinese Society of Clinical Oncology (CSCO)
- Vice Chair, Committee of Integrated Rehabilitation for Breast Cancer, Chinese Anti-Cancer Association (CACA)
- Standing Member, Breast Cancer Expert Committee, CSCO
- Standing Member, Breast Cancer Committee, CACA
- Vice Chair, Oncology Branch, Liaoning Medical Association
- Vice Chair, Breast Cancer Committee, Liaoning Anti-Cancer Association
- Chair, Oncology Branch, Dalian Medical Association
