Herceptin (trastuzumab)

P2, N=184, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Mar 2026

The updated analysis of the phase 3 PHILA trial confirmed the superiority of pyrotinib in combination with trastuzumab and docetaxel over placebo in combination with trastuzumab and docetaxel in sustaining longer progression-free survival and improving overall survival for initial treatment of HER2 positive metastatic breast cancer. The safety profile remained consistent with interim findings, with no new safety signals identified during extended follow-up. This analysis reinforces the efficacy of this dual anti-HER2 (pyrotinib plus trastuzumab) regimen as an effective treatment strategy for this patient population.

P1, N=17, Completed, SOLTI Breast Cancer Research Group | Recruiting --> Completed

Updated analyses pertaining to PFS and safety were generally aligned with data obtained from initial assessments. The OS outcomes further substantiated that the combination of pyrotinib, trastuzumab, and chemotherapy is an alternative therapeutic regimen for managing HER2-positive MBC with heavy pre-treatment in certain situations, particularly among those with non-visceral metastases.

Copy number-based oncogene dominance may suggest tumor dependence and response to HER2-targeted therapy, highlighting a potential novel biomarker in HER2-positive gastric cancer.

P=N/A, N=42, Not yet recruiting, Peking University Cancer Hospital & Institute

Importance of clinical vigilance: Although this patient had no family history of gastric cancer, her nonspecific gastrointestinal symptoms ultimately led to the diagnosis of dual primary SRCC. This highlights the need for high suspicion of malignancy in elderly patients presenting with nonspecific symptoms.Diagnostic value of multidisciplinary collaboration: The integration of endoscopic, pathological, imaging (computed tomography/magnetic resonance imaging), and immunohistochemical findings enabled accurate diagnosis of this rare case of dual primary gastric malignancy and identification of HER2 expression heterogeneity. The heterogeneity in HER2 expression (1+ vs 3+) demonstrates potential molecular differences between lesions in the same patient, emphasizing the necessity for comprehensive biopsy sampling.

Two metastatic SDC patients with HER2 amplification responded to HER2 tyrosine kinase inhibitor (TKI) pyrotinib and the combination of trastuzumab and pertuzumab, respectively. Our work underscores the potential of genomic profiling to guide precision therapy in SDC, with HER2-targeted treatments offering promising therapeutic avenues.

P2, N=30, Recruiting, Ruth O'Regan | Trial completion date: Jan 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jun 2026

P2, N=84, Not yet recruiting, Xijing Hospital

P3, N=868, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting

Paclitaxel was the most used taxane (85%). These findings contribute to regional real-world evidence and underscore the need for neurological monitoring, given the high rate of central nervous system (CNS) progression. Cross-study comparisons remain descriptive due to population and design differences.