The 2025 National Breast Cancer Conference was held in Beijing from April 11 to 13, during which the newly updated 2025 edition of the CSCO Breast Cancer Guidelines (CSCO BC Guidelines) was officially released. Oncology Frontier invited Professor Jianbin Li from the Chinese PLA General Hospital—an expert contributor to the guidelines—to provide an in-depth overview of the key updates, the current landscape of anti-HER2 therapy, and the path forward for further guideline refinement and clinical application.Oncology Frontier: The 2025 edition of the CSCO BC Guidelines was officially released at this year’s National Breast Cancer Conference. Could you share some of the key updates clinicians should pay close attention to?
Professor Jianbin Li: It’s a great honor to have participated in the revision of the 2025 edition of the CSCO BC Guidelines. This year’s guidelines continue to follow the CSCO tradition of evidence-based methodology, while also considering drug accessibility, incorporating advances in precision medicine, and refining treatment strategies based on molecular subtypes and disease stages.
In the context of HER2-positive breast cancer, a notable update is found in the neoadjuvant treatment section. Based on findings from the HELEN-006 clinical trial and supporting real-world data, the THP×6 regimen has been upgraded in the guidelines—from a 2A level of evidence to 1A—and is now included under Grade I recommendations. This reflects both the strength of the new evidence and the growing clinical confidence in this treatment approach.
In the advanced treatment setting for HER2-positive breast cancer, the inclusion of trastuzumab deruxtecan (T-DXd) in the national reimbursement list has prompted updates to both its evidence level and recommendation grade in the 2025 CSCO BC Guidelines. These adjustments reflect not only increased accessibility but also the growing body of clinical evidence supporting T-DXd’s efficacy and safety, solidifying its role as a key option in the management of advanced HER2-positive disease.
Updates in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer (TNBC), the role of immunotherapy in the neoadjuvant setting continues to grow. This year’s CSCO BC Guidelines provide more detailed recommendations regarding the use of immunotherapy for TNBC, reflecting the latest clinical evidence and evolving treatment strategies.
At the same time, the approval and availability of new agents—such as PARP inhibitors and antibody-drug conjugates (ADCs)—have driven updates in the “chemotherapy rescue” section of the guidelines, offering more refined options for patients who may not benefit from standard chemotherapy regimens.
Updates in Hormone Receptor–Positive Breast Cancer
In the hormone receptor–positive (HR+) setting, updates to adjuvant intensified therapy have prompted a more refined stratification of patient subgroups. These adjustments aim to better tailor treatment strategies based on individual risk profiles and disease characteristics.
In the advanced disease setting, for patients who experience progression after CDK4/6 inhibitor therapy, the recent approval of PI3K/AKT/mTOR pathway inhibitors has led to corresponding updates in the guidelines. These changes reflect the growing treatment landscape and provide clinicians with evidence-based options for managing post-CDK4/6 progression in HR+ advanced breast cancer.
Oncology Frontier: During this conference, you shared insights on HER2-targeted therapy. Based on the newly updated CSCO BC Guidelines, how would you describe the current landscape of anti-HER2 treatment in China?
Professor Jianbin Li: Since the introduction of trastuzumab in 1998, breast cancer has officially entered the era of targeted therapy. Over the past two decades—particularly in the last 5 to 10 years—the field of HER2-targeted treatment has undergone transformative changes. The inclusion of trastuzumab in China’s national reimbursement list in 2017 marked a new era for Chinese patients, significantly expanding access to HER2-targeted therapy. By 2020, with the introduction of pertuzumab, we stepped into the dual-targeted treatment era with the HP (trastuzumab + pertuzumab) regimen.
As more targeted therapies have been developed and approved, we’ve since progressed into the era of tyrosine kinase inhibitors (TKIs) and, more recently, the era of antibody-drug conjugates (ADCs). According to the current guidelines, HP dual-targeted therapy remains the standard approach in both neoadjuvant and adjuvant settings. For patients receiving adjuvant therapy, treatment should be tailored based on individual risk profiles. In low-risk patients, single-agent HER2-targeted therapy is still the mainstream approach.
Importantly, this year’s guideline recommends the THP regimen for node-negative patients with high-risk features. This recommendation, in my view, is grounded in the lower toxicity profile and greater accessibility of the HP regimen.
In the advanced disease setting, TKIs and ADCs are offering significant new benefits. The introduction of domestic TKI agents, such as pyrotinib, has reshaped the current treatment landscape by providing additional first- and second-line options for patients who have progressed on trastuzumab-based therapies.
With the advent of the ADC era, novel agents such as T-DXd and SHR-A1811 are redefining clinical practice. For patients with HER2-positive breast cancer, we have transitioned from single-agent therapy to dual-targeted approaches, then to TKI therapies, and now to ADCs. This evolution has not only brought extended survival but also offered more therapeutic options, truly transforming outcomes for patients.
Oncology Frontier: In your view, what are the remaining unresolved issues in anti-HER2 therapy, and which areas of clinical or research focus will be key to strengthening the evidence base and further optimizing the guidelines?
Professor Jianbin Li: Indeed, despite the significant progress we’ve made in HER2-targeted therapy for breast cancer, several areas remain open to discussion, and there are clear directions for future development.
Neoadjuvant Therapy In the neoadjuvant setting, while HP-based dual-targeted therapy is now the standard, the emergence of more ADC drugs has opened up new avenues for exploration. One example is the FASCINATE-N trial initiated by the Breast Surgery Department at Fudan University Shanghai Cancer Center, which suggests that the novel ADC agent SHR-A1811 may reshape clinical practice in this setting. Looking ahead, the DB-11 study on T-DXd could further advance the neoadjuvant landscape by potentially simplifying the traditional four-drug TCHP regimen into a two- or even single-drug approach—improving pathological complete response (pCR) rates while minimizing toxicity.
Adjuvant Therapy In the adjuvant setting, a key question is how to implement targeted intensification following standard therapy. While the ExteNET study showed that neratinib can improve outcomes following trastuzumab-based therapy, current clinical practice in China still favors HP-based dual-targeted intensification. Therefore, determining which patients truly require intensified adjuvant treatment—and identifying which TKI is most appropriate—remains a pressing research need. Ongoing clinical trials are exploring these questions, and we look forward to forthcoming data that could inform and potentially change clinical practice.
First-Line Treatment in Advanced Disease In the first-line setting for advanced HER2-positive breast cancer, whether trastuzumab plus pertuzumab (THP) or trastuzumab plus pyrotinib (TH+TKI) should be the preferred regimen remains a matter of debate. Due to the lack of head-to-head clinical data, treatment decisions must currently rely on prior therapy history and drug accessibility. However, the upcoming DB-09 study, to be presented at the ASCO conference, may shift the paradigm—especially if ADCs emerge as a disruptive force in the first-line setting.
Later-Line Treatment In the later-line setting, our focus is shifting toward treatment strategies after TKI or ADC failure. In particular, post-T-DXd progression is becoming an increasingly important area of investigation as the drug sees broader use. We are currently analyzing real-world data to explore viable options following T-DXd, but prospective studies will be critical to guide optimal treatment decisions for these patients.
In summary, from neoadjuvant to advanced-stage therapy, the anti-HER2 treatment landscape is evolving rapidly. Continued research and data generation are essential to refining strategies and ensuring that the CSCO BC Guidelines remain at the forefront of evidence-based care.
Professor Jianbin Li
PhD, Postdoctoral Fellow, Associate Researcher Assistant Researcher, Institute of Bioengineering, Academy of Military Medical Sciences, General Hospital of the People’s Liberation Army Committee Member, Breast Cancer Expert Committee, Chinese Society of Clinical Oncology (CSCO BC) Managing Editor, Translational Breast Cancer Research
