Editor’s Note: The 2026 National Breast Cancer Conference was held in Beijing from April 10–12, during which the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines 2026 (CSCO BC Guidelines 2026) underwent a major update. At the meeting, Professor Shusen Wang from Sun Yat-sen University Cancer Center presented the latest revisions related to the management of advanced triple-negative breast cancer (TNBC).Oncology Frontier invited Professor Wang to provide an in-depth interpretation of the updated recommendations, the underlying evidence supporting these revisions, and the future directions of research in advanced TNBC.
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Oncology Frontier: The 2026 edition of the CSCO BC Guidelines was officially released during this year’s National Breast Cancer Conference. Compared with the 2025 edition, what major updates were introduced regarding the management of advanced triple-negative breast cancer?
Professor Shusen Wang: In the 2026 edition of the CSCO BC Guidelines, recommendations for advanced TNBC continue to be divided into two major categories: immunotherapy-based combination treatment and salvage chemotherapy.
Within the salvage chemotherapy section, the 2026 guidelines maintain the same framework used in the 2025 edition by stratifying patients according to whether they are “taxane-sensitive” or “taxane-refractory.”
For taxane-sensitive patients, single-agent taxane chemotherapy has been downgraded from a previous Category I recommendation to a Category II recommendation (Level 2A evidence).
In the Category II recommendations for both taxane-sensitive and taxane-refractory populations, the positioning of fluzoparib plus apatinib versus fluzoparib monotherapy has also been adjusted. In the 2025 guidelines, fluzoparib plus apatinib was listed at the end of the Category II recommendations (Level 2A evidence) for taxane-sensitive patients. In the 2026 edition, however, the regimen has been moved to a preferred position within the Category II recommendations with upgraded Level 1B evidence.
Importantly, this recommendation specifically applies to patients harboring BRCA1/2 mutations, for whom fluzoparib plus apatinib is now considered a preferred strategy.
In addition, based on data from studies such as OptiTROP-Breast01 and ASCENT-03, the 2026 guidelines added sacituzumab govitecan (SG; Level 1B evidence) and sacituzumab tirumotecan (Level 2A evidence) to the Category II recommendations for taxane-sensitive patients.
For taxane-refractory patients, all Category I recommendations in the 2025 guidelines consisted of chemotherapy regimens. In the 2026 update, however, single-agent sacituzumab govitecan (Level 1B evidence) and sacituzumab tirumotecan (Level 2A evidence) were newly added.
Furthermore, among taxane-refractory patients with BRCA1/2 mutations, the recommendation level for fluzoparib plus apatinib has been upgraded from Category II to Category I, with the evidence level elevated from 2A to 1A.
For taxane-refractory patients overall, fluzoparib monotherapy has also been upgraded from a previous Category III recommendation to Category II, with evidence strengthened from Level 2A to Level 1B.
Regarding immunotherapy-based treatment, the corresponding section in the 2025 guidelines was titled “Salvage Chemotherapy + Immunotherapy,” whereas the 2026 edition has renamed the section “Immunotherapy-Based Combination Therapy.”
Previously, both Category I and Category II recommendations in this section were centered on chemotherapy combined with immunotherapy. However, in the 2026 guidelines, SG plus a PD-1 inhibitor (Level 1B evidence) has been newly incorporated into the Category II recommendations for both taxane-sensitive and taxane-refractory patients, reflecting a clear decline in the central role of conventional chemotherapy.
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Oncology Frontier: What recent clinical evidence and unmet clinical needs drove these updates? In your opinion, how will the 2026 guideline revisions influence real-world treatment decision-making?
Professor Shusen Wang: These updates are supported by a series of evidence-based clinical studies.
For example, the addition of the ADC sacituzumab govitecan in the salvage chemotherapy section is primarily based on results from the ASCENT-03 trial.
ASCENT-03 was an open-label, randomized Phase III study enrolling patients with previously untreated unresectable locally advanced or metastatic TNBC who were considered unsuitable for PD-1/PD-L1 inhibitors. Eligible populations included patients who were PD-L1-negative (CPS <10), PD-L1-positive (CPS ≥10) but previously exposed to PD-(L)1 inhibitors in the early-stage setting, or patients unable to tolerate PD-(L)1 inhibitors because of comorbidities.
The study evaluated the efficacy and safety of SG compared with chemotherapy in this patient population.
The results demonstrated that, according to blinded independent central review (BICR), median progression-free survival (PFS) in the SG arm was prolonged by 2.8 months compared with chemotherapy, while the risk of disease progression or death was reduced by 38% (9.7 vs 6.9 months; HR 0.62, 95% CI 0.50–0.77; P<0.0001). Consistent benefits were observed across all predefined subgroups.
Based on these findings, the 2026 CSCO BC Guidelines incorporated SG for taxane-refractory patients. However, because the drug has not yet been included in China’s national reimbursement list, it is currently categorized as a Category II recommendation.
In addition, the newly added recommendation of “SG + PD-1 inhibitor” (Level 1B evidence) in the immunotherapy section is mainly supported by findings from the ASCENT-04 study.
ASCENT-04 enrolled previously untreated patients with PD-L1-positive unresectable locally advanced or metastatic TNBC. Results showed that median PFS reached 11.2 months in the SG plus pembrolizumab arm, compared with 7.8 months in the chemotherapy plus pembrolizumab arm, representing an absolute benefit of 3.4 months and a 35% reduction in the risk of progression or death (HR 0.65, 95% CI 0.51–0.84; P<0.001).
Based on these results, the 2026 guidelines added SG plus PD-1 inhibitor therapy to the immunotherapy-based treatment recommendations.
The downgrading of single-agent chemotherapy from Category I to Category II was also largely driven by ASCENT-03. In addition, although the TROPION-Breast02 study has not yet been incorporated into this year’s guidelines, the trial demonstrated very promising results for datopotamab deruxtecan (Dato-DXd) compared with chemotherapy in previously untreated patients with unresectable locally recurrent or metastatic TNBC who were unsuitable for immunotherapy.
Because newer therapies are now demonstrating superior efficacy compared with conventional single-agent chemotherapy, the recommendation level for chemotherapy has naturally been reduced. However, it is important to emphasize that this does not mean single-agent chemotherapy should no longer be used. In real-world practice, treatment selection must still be individualized according to each patient’s specific clinical circumstances.
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Oncology Frontier: Looking ahead, which research areas or drug development strategies do you believe hold the greatest potential to further transform the treatment landscape and future guideline recommendations for advanced TNBC?
Professor Shusen Wang: Although we have made meaningful progress in advanced TNBC, the clinical reality remains extremely challenging.
Even with the best currently available therapies, overall survival remains disappointingly short—approximately two years in many cases—which clearly indicates a substantial unmet clinical need.
Therefore, we urgently need more effective therapeutic strategies. This includes gaining deeper insight into advanced TNBC biology, particularly its underlying biological behavior.
Can we further refine the molecular subtyping of TNBC? Can we better understand its biological heterogeneity and subsequently develop truly individualized treatment strategies? I believe these remain critically important research directions.
In addition, we should continue exploring novel combination strategies involving existing agents—for example, combining ADCs with antiangiogenic therapies or immunotherapy—in hopes of achieving superior efficacy.
At the same time, many of these studies inevitably involve the issue of drug resistance. As ADCs move from later-line settings into earlier lines of therapy, and from monotherapy into combination regimens, resistance mechanisms will become increasingly important.
What drives resistance to ADCs? How can we overcome or reverse resistance in order to improve treatment outcomes?
These are among the most important and promising research questions moving forward.
Professor Shusen Wang
Sun Yat-sen University Cancer Center
