Drugs / SHR-A1811
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | female breast nipple and areola cancer | — | “In September 2025, the new indication for Trastuzumab Rezetecan in breast cancer was accepted by China’s NMPA for review” glenmarkpharma.com ↗ “2025年9月，瑞康曲妥珠单抗用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺癌患者的新适应症上市申报已获受理” hengrui.com ↗ |
Trials 82 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07275242 | Dec 2025 → Jun 2027 expected | cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06710990 | Feb → Oct 2025 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04513223 | Mar 2021 → Mar 2025 | colorectal cancer, gastric cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04446260 | Sep 2020 → Jun 2025 | cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1/215 trials | ||||||
| Phase 1/2 | NCT07231211 | Nov 2025 → Oct 2026 expected | cancer | Shanghai Shengdi Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07140393 | Oct 2025 → Oct 2027 expected | neoplasm | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07177950 | Sep 2025 → Sep 2028 expected | breast cancer, metastatic malignant neoplasm in the brain, neoplastic meningitis | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06990516 | Jun 2025 → Jun 2030 expected | ovarian cancer | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06859775 | Apr 2025 → Oct 2026 expected | — | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06840002 | Mar 2025 → Dec 2026 expected | ovarian cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06788197 | Mar 2025 → Mar 2028 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06718933 | Jan 2025 → Aug 2026 overdue | breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06222879 | Feb 2024 → Oct 2026 expected | breast cancer | Shandong Suncadia Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06015048 | Aug 2023 → Nov 2026 expected | — | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05845138 | Jul 2023 → Dec 2024 | breast cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05792410 | Apr 2023 → Feb 2024 | Her2-receptor negative breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05824325 | Mar 2023 → Apr 2025 overdue | breast cancer | Fudan University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05482568 | Sep 2022 → Dec 2026 expected | non-small cell lung carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04818333 | Apr 2021 → Jun 2025 | non-small cell lung carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 248 trials · 1 met primary | ||||||
| Phase 2 | NCT07856303 | Oct 2026 → Aug 2032 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07817082 | Sep 2026 → Sep 2028 expected | breast cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07560475 | Jun 2026 → Dec 2028 expected | HER2 positive breast carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07618923 | Jun 2026 → Jun 2028 expected | hormone receptor-positive breast cancer | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527806 | May 2026 → May 2029 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07528898 | May 2026 → Jul 2027 expected | breast cancer | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07489703 | Apr 2026 → Dec 2027 expected | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07417241 | Mar 2026 → Jan 2029 expected | HER2 positive breast carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07466303 | Mar 2026 → Feb 2028 expected | female breast carcinoma, progesterone-receptor negative breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07466927 | Mar 2026 → Jan 2028 expected | Her2-receptor negative breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07317778 | Feb 2026 → Oct 2028 expected | female breast carcinoma, hormone receptor-positive breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07340398 | Dec 2025 → Dec 2028 expected | HER2 positive breast carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07307287 | Dec 2025 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07309770 | Dec 2025 → Sep 2027 expected | bladder urachal carcinoma | Sheng Zhang | Recruiting | No outcome recorded |
| Phase 2 | NCT07305246 | Dec 2025 → Mar 2027 expected | breast cancer | First Hospital of China Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281209 | Dec 2025 → Dec 2027 expected | non-small cell lung carcinoma | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07051486 | Oct 2025 → Feb 2026 overdue | — | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07129187 | Oct 2025 → Oct 2026 expected | HER2 positive breast carcinoma, female breast carcinoma | Chuan Wang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07102901 | Sep 2025 → Dec 2027 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06973525 | Sep 2025 → May 2027 expected | HER2 positive breast carcinoma | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07132242 | Aug 2025 → Aug 2028 expected | HER2 positive breast carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07110571 | Aug 2025 → Aug 2026 overdue | gastric cancer, gastroesophageal cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06975475 | Jun 2025 → Jun 2027 expected | breast cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06975462 | Jun 2025 → Jun 2027 expected | breast cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06881017 | May 2025 → Aug 2029 expected | gastric cancer, gastroesophageal junction adenocarcinoma | China Medical University, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06927180 | Apr 2025 → May 2029 expected | female breast carcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06778031 | Feb 2025 → Jun 2028 expected | carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06666166 | Dec 2024 → Jul 2028 expected | colorectal cancer, gastric carcinoma, gastroesophageal junction adenocarcinoma | Yunpeng Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06649331 | Oct 2024 → Sep 2026 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06547736 | Oct 2024 → Mar 2027 expected | malignant pancreatic neoplasm | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06592625 | Sep 2024 → Feb 2026 overdue | breast carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06340230 | Aug 2024 → Feb 2026 overdue | hormone receptor-positive breast cancer | Shengjing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06433609 | Aug 2024 → Mar 2027 expected | breast cancer | Beijing GoBroad Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06413745 | Jun 2024 → Dec 2026 expected | carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06411457 | May 2024 → May 2025 | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT06361979 | May 2024 → May 2025 | female breast carcinoma | Huihua Xiong | Unknown | No outcome recorded |
| Phase 2 | NCT05924256 | Jul 2023 → Dec 2026 expected | salivary gland carcinoma | Fudan University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05896020 | Jul 2023 → Jun 2026 | female reproductive organ cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05911958 | Jul 2023 → Dec 2024 overdue | breast carcinoma by gene expression profile | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05769010 | Mar 2023 → Dec 2028 expected | breast cancer | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05749588 | Mar 2023 → Dec 2027 expected | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05635487 | Mar 2023 → Feb 2025 overdue | HER2 positive breast carcinoma | Shengjing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05671822 | Mar 2023 → Dec 2027 expected | gastroesophageal adenocarcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05594095 | Dec 2022 → Dec 2025 overdue | female breast carcinoma, hormone receptor-positive breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05582499 | Nov 2022 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05076682 | Jun 2022 → Dec 2026 expected | triple-negative breast carcinoma | Fudan University | Recruiting | Met primary |
| Phase 2 | NCT05349409 | Jun 2022 → Nov 2024 | cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05353361 | May 2022 → Dec 2025 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 314 trials · 2 met primary | ||||||
| Phase 3 | NCT07676162 | Aug 2026 → Sep 2029 expected | colorectal cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07528716 | May 2026 → Dec 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT07196774 | Oct 2025 → Dec 2027 expected | breast carcinoma by gene expression profile | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07111832 | Aug 2025 → Mar 2028 expected | triple-negative breast carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07118527 | Aug 2025 → Oct 2030 expected | gastroesophageal adenocarcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06990503 | Jun 2025 → Jun 2030 expected | ovarian cancer | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06828354 | Mar 2025 → May 2027 expected | ovarian cancer | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06430437 | Jul 2024 → Feb 2026 overdue | non-small cell lung carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06199973 | Mar 2024 → Apr 2026 overdue | colorectal cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06123494 | Jan 2024 → Jun 2027 expected | gastroesophageal adenocarcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06126640 | Nov 2023 → Apr 2030 expected | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06057610 | Nov 2023 → Jul 2026 overdue | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT05814354 | Jun 2023 → Jan 2025 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05424835 | Aug 2022 → Dec 2026 expected | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07377916 | Feb 2026 → Jun 2029 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT07355764 Comparator | Dec 2025 → Jan 2028 expected | colorectal cancer | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07047443 Background | Aug 2025 → Dec 2027 expected | breast cancer | Anhui Provincial Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07669610 Comparator | Oct 2026 → Sep 2028 expected | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07382687 Comparator | Feb 2026 → Dec 2028 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-09-01 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞ADC创新药瑞康曲妥珠单抗单药或联合帕妥珠单抗一线治疗HER2阳性晚期乳腺癌III期临床研究达到主要终点 hengrui.com ↗
方案预设的期中分析结果表明，与对照组相比，瑞康曲妥珠单抗联合或不联合帕妥珠单抗均可显著降低患者疾病进展/死亡风险 1 。 |
| 2026-08-26 | Jiangsu HengRui Medicine Co., Ltd. | Results 高表达人群ORR达91.7%！恒瑞ADC创新药瑞康曲妥珠单抗治疗晚期唾液腺癌HER2分层II期研究荣登JCO hengrui.com ↗
HER2高表达队列（n=24）中位随访21.9个月，确认ORR高达91.7%（95% CI：73.0-99.0），含4例完全缓解（CR）、18例部分缓解（PR），疾病控制率（DCR）为95.8%；中位DoR、PFS、OS均未达到，中位TTR仅为1.7个月。 |
| 2026-07-02 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer glenmarkpharma.com ↗
India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). |
| 2026-04-10 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞HER2 ADC创新药瑞康曲妥珠单抗晚期实体瘤全球I期临床最终分析登上《自然》子刊STTT hengrui.com ↗ |
| 2026-03-23 | Jiangsu HengRui Medicine Co., Ltd. | Results 荣登JCO！恒瑞HER2 ADC创新药瑞康曲妥珠单抗治疗胃/胃食管结合部腺癌和结直肠癌I期结果发布 hengrui.com ↗
研究结果初步展示了瑞康曲妥珠单抗在HER2表达的GC/GEJ和CRC患者中具有良好的抗肿瘤活性和安全性 [1] 。 |
| 2025-10-23 | Jiangsu HengRui Medicine Co., Ltd. | Results 2025 ESMO口头报告︱达到主要终点！恒瑞ADC创新药瑞康曲妥珠单抗有望为HER2阳性晚期乳腺癌患者带来新希望 hengrui.com ↗
BICR评估的中位PFS方面，瑞康曲妥珠单抗组达到30.6个月（95%CI：16.8-NR），吡咯替尼联合卡培他滨组为8.3个月（95%CI：6.9-11.0）。 |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-01 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞ADC创新药瑞康曲妥珠单抗单药或联合帕妥珠单抗一线治疗HER2阳性晚期乳腺癌III期临床研究达到主要终点 hengrui.com ↗ |
| 2026-08-26 | Jiangsu HengRui Medicine Co., Ltd. | 高表达人群ORR达91.7%！恒瑞ADC创新药瑞康曲妥珠单抗治疗晚期唾液腺癌HER2分层II期研究荣登JCO hengrui.com ↗ |
| 2026-07-02 | Glenmark Pharmaceuticals Ltd. India | Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer glenmarkpharma.com ↗ |
| 2026-04-10 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞HER2 ADC创新药瑞康曲妥珠单抗晚期实体瘤全球I期临床最终分析登上《自然》子刊STTT hengrui.com ↗ |
| 2026-03-23 | Jiangsu HengRui Medicine Co., Ltd. | 荣登JCO！恒瑞HER2 ADC创新药瑞康曲妥珠单抗治疗胃/胃食管结合部腺癌和结直肠癌I期结果发布 hengrui.com ↗ |
| 2025-10-23 | Jiangsu HengRui Medicine Co., Ltd. | 2025 ESMO口头报告︱达到主要终点！恒瑞ADC创新药瑞康曲妥珠单抗有望为HER2阳性晚期乳腺癌患者带来新希望 hengrui.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR - A1811 | “Injection SHR - A1811 (hereinafter referred to as SHR - A1811) is an antibody - drug conjugate (ADC) targeting the HER2 protein” NCT06990503 ↗88“SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle.” NCT07669610 ↗ “Patients with advanced breast cancer expressing HER2 received SHR-A1811 + carboplatin treatment.” NCT07047443 ↗ “SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical” NCT07307287 ↗ “SHR-A1811: 4.8mg/kg given into the vein (IV; intravenously) every 21 days” NCT07527806 ↗ “Phase II Study of SHR-A1811 for Ultra-Low HER2 Advanced Breast Cancer” NCT07817082 ↗ “Drug: SHR- A1811” NCT05896020 ↗ |
| Known as | ruikang-trastuzumab | “SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical” NCT07307287 ↗ |
| Known as | Trastuzumab Restuzumab | “SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate)” NCT07466303 ↗ |
| Known as | Trastuzumab Rezetecan | “Trastuzumab rezetecan (also known as SHR-A1811) is a novel antibody-drug conjugate consisting of a humanised HER2-directed monoclonal antibody, cleavable tetrapeptide-based...” PMID 40020696 ↗ Feb 20251“Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.” NCT07309770 ↗ |
| Action | Inhibit | “an anti-HER2 antibody-drug conjugate (ADC)” NCT05749588 ↗ |
| Modality | Monoclonal antibody | “an anti-HER2 antibody-drug conjugate (ADC)” NCT05582499 ↗ |
| Route | Intravenous | “SHR-A1811 was administered intravenously at doses ranging from 1.0 to 8.0 mg/kg once every 3 weeks.” PMID 38900984 ↗ Jun 2024 |
| Target | ERBB2 | “antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2)” PMID 41779980 ↗ Mar 2026 |