AiRuiNi (pyrotinib) / Jiangsu Hengrui Pharma, HLB Bio Group - LARVOL DELTA

Trastuzumab deruxtecan plus pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: interim analysis of the TROPHY study (ESMO Asia 2026) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Pyrotinib plus dalpiciclib and letrozole in ER-positive/HER2-positive advanced breast cancer: updated phase II results (ESMO Asia 2026) - No abstract available

Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Neoadjuvant Pyrotinib Monotherapy in HER2-Positive Ductal Carcinoma In Situ: A Phase II Single-Arm Study (ESMO Asia 2026) - No abstract available

Clinical • Monotherapy • P2 data • Breast Cancer • Oncology • HER-2

Outcomes of Liver Transplantations in Elderly Patients > 70 Years: A Ongoing Retrospective Internal Review (ASA 2026) - "Irene Kimlee, M.D. and James D. Kindscher, M.D. of the Department of Anesthesiology was performed...Furthermore, the expanded analysis showed statistically significant median differences between OLT indications where the younger cohort had an increased prevalence of alcohol-related liver cirrhosis that may be reflective of possible social epidemiological age-related trends in ESLD. Postoperative median differences for immediate and 30-day morbidity, mortality, and 12-month graft survival continued to not show statistical significance, further suggesting comparable post-OLT outcomes in the growing > 70 patient population."

Retrospective data • Review • Cardiovascular • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Transplantation

Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=226 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Peking Union Medical College | Initiation date: Dec 2023 ➔ May 2024

Trial initiation date • Oncology • Salivary Gland Cancer • HER-2 • NTRK

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P1/2 | N=716 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Peking Union Medical College | N=30 ➔ 10

Enrollment change • Oncology • Salivary Gland Cancer • HER-2 • NTRK

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Peking Union Medical College | Trial primary completion date: Jul 2026 ➔ Jul 2028

Trial primary completion date • Oncology • Salivary Gland Cancer • HER-2 • NTRK

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Peking Union Medical College

New P2 trial • Oncology • Salivary Gland Cancer • HER-2 • NTRK

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P1/2 | N=716 | Not yet recruiting | Sponsor: Fudan University

New P1/2 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Peking Union Medical College | N=10 ➔ 39 | Trial completion date: Jul 2026 ➔ Jul 2028

Enrollment change • Trial completion date • Oncology • Salivary Gland Cancer • HER-2 • NTRK

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Phase classification: P1/2 ➔ P2

Phase classification • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Peking University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

ESCC-PT: Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer (clinicaltrials.gov) - P2/3 | N=90 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

Checkpoint inhibition • New P2/3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • PD-L1

Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023) - "Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35,..."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

Dalpiciclib plus Pyrotinib-based chemotherapy-free regimens as first line treatment in Trastuzumab-Sensitive, HER2-positive metastatic breast cancer (DAP-HER-02): A dual-cohort, phase II study (ESMO 2026) - P2 | "In Cohort B, the median follow-up was 26.7 months (95% CI: 20.0-33.7), with a median PFS of 29.1 months (95% CI: 21.4-36.8). The most common grade 3 or 4 treatment-related adverse events (TRAEs) were neutrophil count decreased (Cohort A/Cohort B: 56.1% /36.7%), white blood cell count decreased (39.0%/27.8%), and diarrhea (36.6% /27.8%).Conclusions In trastuzumab-sensitive, untreated HER2-positive metastatic BC, dalpiciclib plus pyrotinib combined with fulvestrant or inetetamab demonstrated substantial antitumor activity with manageable toxicity, offering a promising chemotherapy-free treatment option."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Multicenter, Open-Label, Randomized, Phase II Clinical Trial of Trastuzumab Rezetecan-based Therapy for Brain Metastases in HER2-Positive Breast Cancer (ChiCTR) - P2 | N=108 | Sponsor: ChongQing university cancer hospital; ChongQing university cancer hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

JS105-002: A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Not yet recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

TROPHY: Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial (clinicaltrials.gov) - P4 | N=51 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

TAYLOR-002: Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2