The 2025 National Breast Cancer Conference was grandly held in Beijing from April 11 to 13. With the theme of “Learning · Absorbing · Innovating · Improving,” the event brought together leading domestic and international experts in breast cancer, along with cross-disciplinary and cross-industry specialists, to discuss the latest advances in diagnosis and treatment, and to witness the release of the 2025 edition of the CSCO Breast Cancer Guidelines (CSCO BC Guidelines).At the conference, Professor Man Li from The Second Hospital of Dalian Medical University presented and interpreted the updated recommendations for systemic therapy in advanced HER2-positive breast cancer. In an exclusive interview with Oncology Frontier, Professor Li further summarized the highlights of the latest guideline revisions and shared her perspective on how these updates may shape future clinical practice.
Oncology Frontier: The updated CSCO BC Guidelines were once again released at this year’s National Breast Cancer Conference. Professor Li, could you please summarize the key updates in the systemic treatment of advanced HER2-positive breast cancer that you presented?
Professor Man Li: The release of the 2025 edition of the CSCO BC Guidelines has drawn significant attention from breast cancer specialists nationwide. At this conference, I focused on the updates related to the treatment of advanced HER2-positive breast cancer.
The 2025 guidelines continue to adopt a stratified treatment approach, aligning more closely with current clinical practice. Recommendations are divided into three categories: patients who are trastuzumab-sensitive, those with trastuzumab-resistant disease, and those with TKI-resistant disease.
For trastuzumab-sensitive patients, first-line (Grade I) recommendations remain unchanged from the 2024 version. They continue to include trastuzumab + pertuzumab + taxane (THP), as well as trastuzumab + TKI combinations such as TH + pyrotinib (based on the PHILA study), both supported by Level 1A evidence. This underscores the continued importance of dual anti-HER2 therapy in this subgroup.
Regarding second-tier (Grade II) recommendations for trastuzumab-sensitive patients, the 2024 guidelines included single-target therapy with double chemotherapy, and single-target therapy with single chemotherapy, both supported by Level 2A evidence.
In the 2025 update, the Grade II recommendations emphasize more diverse chemotherapy options when combined with trastuzumab and pertuzumab. In addition to standard agents like taxanes and capecitabine, other chemotherapies such as eribulin and vinorelbine have been incorporated.
Notably, the Phase III EMERALD study, presented at the 2024 ASCO Annual Meeting, directly compared THP + paclitaxel versus THP + eribulin. The results showed non-inferiority in terms of progression-free survival (PFS), with comparable efficacy between the two arms.
As a result, the 2025 guidelines reflect this finding by expanding chemotherapy options under the Grade II recommendations for trastuzumab-sensitive patients.
These updates both the elements that remain unchanged and those that have evolved—highlight that dual HER2-targeted therapy remains the backbone of treatment for this breast cancer subtype, while chemotherapy choices have become increasingly diverse and individualized.
For patients with trastuzumab treatment failure, the Grade I recommendations in the 2024 guidelines included two main therapeutic strategies: T-DXd (trastuzumab deruxtecan) and pyrotinib combined with capecitabine. Although both were supported by Level 1A evidence, the recommendation table previously listed pyrotinib + capecitabine first, followed by T-DXd.
In the 2025 edition of the CSCO BC Guidelines, this order has been revised, placing T-DXd at the top of the Grade I recommendations. This change reflects the growing recognition of antibody-drug conjugates (ADCs), particularly T-DXd, as a pivotal therapeutic option in this setting.
The DB-03 clinical trial demonstrated that T-DXd significantly improved progression-free survival (PFS) and overall survival (OS) compared to T-DM1, reinforcing its efficacy. Furthermore, T-DXd’s recent inclusion in China’s national reimbursement list makes it more accessible and practical for Chinese patients, aligning the guidelines more closely with current clinical practice and national policy.
As for Grade II recommendations, the 2024 guidelines listed T-DM1 as a Level 1A option. In the 2025 update, this has been revised to Level 1B, signaling a shift in treatment priority. The guidelines now clearly support T-DXd and domestically developed regimens such as pyrotinib + capecitabine as preferred options, with T-DM1 remaining a secondary choice.
These adjustments underscore a broader move toward evidence-based prioritization of novel therapies that are both clinically effective and locally accessible, helping to ensure that treatment decisions are optimized for the needs and realities of patients in China.
For patients who progress after trastuzumab and have previously received TKI-based therapy, the 2024 edition of the guidelines did not provide a Grade I recommendation, leaving a notable gap in this treatment sequence.
However, the 2025 edition of the CSCO BC Guidelines addresses this directly by elevating T-DXd (trastuzumab deruxtecan) to a Grade I recommendation, supported by Level 1A evidence, for this subgroup. This update reflects the growing consensus around the efficacy of T-DXd, even in patients previously treated with TKIs.
This change is grounded in data from the DB-03 clinical trial, which included a subset of patients (approximately 16%) who had been treated with TKI therapies. In this subgroup, T-DXd continued to show meaningful clinical benefit, further validating its role in later-line therapy.
By upgrading T-DXd’s position in the treatment algorithm for TKI-refractory HER2-positive advanced breast cancer, the 2025 guidelines reinforce its status as a key therapeutic option, and fill an important gap in sequential treatment planning. This adjustment also aligns with a broader emphasis on evidence-based precision and personalization in managing complex treatment pathways.
Looking at the 2025 edition of the CSCO BC Guidelines as a whole, the “unchanged” aspect is the continued emphasis on the importance of dual HER2-targeted therapy with trastuzumab and pertuzumab, as well as the significance of precise stratified treatment.
The “changes” reflect the rising importance of the novel ADC agent T-DXd, and also highlight that pyrotinib, a domestically developed small-molecule TKI, remains an important option for Chinese patients—both in first-line and second-line treatment settings.
Oncology Frontier: In your view, what changes will this year’s guideline update bring to clinical practice in breast cancer diagnosis and treatment?
Professor Man Li: This year’s guideline update clearly reflects the theme of “change and continuity.” What remains unchanged is the consistent application of precise stratified treatment. The guidelines continue to categorize patients into trastuzumab-sensitive, trastuzumab-resistant, and TKI-resistant groups. This stratification closely mirrors real-world clinical scenarios and provides strong evidence-based guidance to help clinicians determine treatment strategies.
Building on this stratification, the guidelines also define different levels of recommendations, which further highlights the value of precision medicine in guiding treatment decisions.
In addition to stratification, this year’s edition places greater emphasis on individualized treatment. For all three patient groups—trastuzumab-sensitive, trastuzumab-resistant, and TKI-resistant—the Grade I recommendations now offer more options. For example, trastuzumab-sensitive patients with advanced HER2-positive breast cancer can receive dual HER2-targeted therapy with a taxane, or a combination of trastuzumab + TKI (such as pyrotinib) + taxane. These diverse options reflect real-world clinical needs, allowing physicians to tailor treatment based on factors such as the site of metastasis and drug sensitivity.
For patients who have failed trastuzumab therapy, both T-DXd and pyrotinib plus capecitabine are included as Grade 1A recommendations. In clinical practice, physicians can make decisions based on individual characteristics, metastasis patterns, and tumor burden, further demonstrating the importance of personalized treatment.
It’s clear that the CSCO BC Guidelines continue to explore future treatment directions. Drug resistance remains one of the most critical challenges in treating advanced HER2-positive breast cancer. Overcoming resistance is a key focus moving forward.
Looking ahead, potential areas for deeper investigation include combinations of ADCs and TKIs, ADCs and immunotherapy, and ADCs with DNA damage repair agents. At the same time, identifying effective biomarkers to guide treatment selection will be essential. Circulating tumor DNA (ctDNA), as a potential biomarker, is showing increasing promise, and with continued research and longer-term follow-up, it may play an important role in guiding clinical decisions in the future.
Professor Man Li
MD, PhD | Professor | Doctoral Supervisor Chief of the Department of Oncology and Director of the Teaching & Research Office The Second Hospital of Dalian Medical University
- Head of the Clinical Trial Ward
- Distinguished Professor of Liaoning Province; Standing Member of the Chinese Society of Clinical Oncology (CSCO)
- Chair, Committee on Breast Cancer Integration and Recurrence, Chinese Anti-Cancer Association (CACA)
- Standing Member, Committee on Breast Cancer, Chinese Society of Clinical Oncology (CSCO)
- Standing Member, Breast Cancer Professional Committee, CACA
- Deputy Chair, Liaoning Medical Association Oncology Branch
- Chair, Breast Cancer Committee, Liaoning Anti-Cancer Association
- Chair, Oncology Branch, Dalian Medical Association
