42 completed, 18 recruiting, 8 terminated, 8 unknown. 55 Phase 2, 37 Phase 1, 4 Phase 3, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer Neratinib + endocrine therapy, Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, CDK4/6 + Endocrine therapy - Metastatic Invasive Breast Cancer, Resistant Breast Cancer | Phase 2 | Not yet recruiting | University of California, San Diego | 150 | 2027-07-01 | 2026-07-27 |
| T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis Neratinib, Trastuzumab Deruxtecan - Breast Cancer With Brain Metastasis, HER2-positive Breast Cancer | Phase 2 | Recruiting | Fudan University | 202 | 2025-09-24 | 2026-09-28 |
| Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study Neratinib (HKI-272) - HER2-positive Breast Cancer | Not yet recruiting | Hebei Medical University Fourth Hospital | 170 | 2025-06-30 | 2025-06-13 | |
| Using Tumor Models to Determine Treatments Cobimetinib, Ponatinib, Brigatinib - Pancreatic Ductal Carcinoma, Advanced Cancer | Phase 2 | Recruiting | University Health Network, Toronto | 25 | 2025-04-07 | 2026-06-23 |
| Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS Albumin-Bound Paclitaxel, Epirubicin, Gemcitabine - Rare Tumour | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | 200 | 2025-01-01 | 2024-11-18 |
| Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor Fulvestrant, Neratinib, Alpelisib - Advanced Breast Cancer | Phase 2 | Recruiting | Dartmouth-Hitchcock Medical Center | 135 | 2024-09-23 | 2026-01-20 |
| Neratinib in Combination With Ruxolitinib in Patients With mTNBC Neratinib Oral Tablet, Ruxolitinib Oral Tablet - Metastatic Triple-Negative Breast Carcinoma, Breast Cancer | Early Phase 1 | Recruiting | Baylor Research Institute | 20 | 2024-09-16 | 2026-10-13 |
| Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations Neratinib tablets - Advanced Solid Tumor | Phase 2 | Unknown | Convalife (Shanghai) Co., Ltd. | 60 | 2024-08-10 | 2024-07-25 |
| Personalized Medicine for Advanced Biliary Cancer Patients Futibatinib, Ivosidenib, Zanidatamab - Biliary Tract Neoplasms | Phase 3 | Recruiting | UNICANCER | 800 | 2024-07-18 | 2026-05-19 |
| Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers Endocrine Therapy, Biopsy of breast, Neratinib - Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer | Phase 2 | Recruiting | Vanderbilt-Ingram Cancer Center | 30 | 2024-06-11 | 2026-08-19 |
| Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) Biopsy Procedure, Biospecimen Collection, Computed Tomography - Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm | Phase 2 | Recruiting | National Cancer Institute (NCI) | 70 | 2024-05-07 | 2026-11-05 |
| Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases Neratinib maleate in combination with capecitabine - Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis | Phase 2 | Not yet recruiting | Convalife (Shanghai) Co., Ltd. | 28 | 2024-04-30 | 2024-04-19 |
| Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer Neratinib, Trastuzumab, Oxaliplatin - GastroEsophageal Cancer, Gastric Cancer | Phase 2 | Active not recruiting | H. Lee Moffitt Cancer Center and Research Institute | 8 | 2024-01-12 | 2026-06-12 |
| Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations Neratinib tablets - NSCLC | Phase 2 | Unknown | Convalife (Shanghai) Co., Ltd. | 42 | 2023-11-20 | 2023-09-08 |
| Fulvestrant + Neratinib In Breast Cancer NERATINIB, FULVESTRANT - Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer | Phase 2 | Withdrawn | Massachusetts General Hospital | 2023-07-01 | 2023-08-01 | |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Alpelisib, Binimetinib, Biopsy Procedure - Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 2900 | 2023-04-07 | 2026-11-12 |
| Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab Trastuzumab and neratinib, Trastuzumab and Pertuzumab - Early-stage Breast Cancer, HER2-positive Breast Cancer | Phase 3 | Recruiting | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 300 | 2023-03-14 | 2025-09-25 |
| Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease Neratinib - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Recruiting | University Health Network, Toronto | 15 | 2022-12-06 | 2026-10-13 |
| Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene Biopsy Procedure, Biospecimen Collection, Computed Tomography - Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma | Phase 1 | Recruiting | National Cancer Institute (NCI) | 58 | 2022-10-05 | 2026-11-12 |
| Treatment Patterns of Neratinib in HER2+ EBC in China Neratinib - Breast Cancer | Unknown | Pierre Fabre Medicament | 500 | 2022-09-30 | 2022-08-08 |
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Breast Neoplasms (39) · Neoplasm Metastasis (10) · Neoplasms (7) · Brain Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (3) · Pancreatic Neoplasms (3) · Triple Negative Breast Neoplasms (3) · Colorectal Neoplasms (2) · Lung Neoplasms (2) · Ovarian Neoplasms (2) · Prostatic Neoplasms (2) · Stomach Neoplasms (2) · Anemia (1) · Biliary Tract Neoplasms (1) · Blast Crisis (1)
Puma Biotechnology, Inc. (34) · NSABP Foundation Inc (5) · Convalife (Shanghai) Co., Ltd. (3) · M.D. Anderson Cancer Center (3) · National Cancer Institute (NCI) (3) · Dana-Farber Cancer Institute (2) · Memorial Sloan Kettering Cancer Center (2) · University Health Network, Toronto (2) · Virginia Commonwealth University (2) · Baylor Research Institute (1) · Beth Israel Deaconess Medical Center (1) · Chinese Academy of Medical Sciences (1) · City of Hope Medical Center (1) · Dartmouth-Hitchcock Medical Center (1) · David Reardon, MD (1)
United States (62) · France (14) · China (13) · Spain (13) · Canada (12) · Belgium (9) · United Kingdom (9) · Hong Kong (8) · Japan (8) · South Korea (8) · Australia (7) · Germany (6) · Italy (6) · Poland (6) · Switzerland (6)
Norman Wolmark, MD (5) · Andrew Poklepovic, MD (2) · Aditya Bardia, MD,MPH (1) · Ajay Dhakal (1) · Andrew Davis (1) · Asona Lui, MD, PhD (1) · Chau Dang, MD (1) · Corinne Vannier, Dr (1) · Cynthia Ma, M.D., Ph.D (1) · Dae Won Kim, MD (1) · David Einstein, MD (1)
PMID 37597578, PMID 24077916, PMID 35181666, PMID 41193346, PMID 21796368, PMID 22198468, PMID 22371427, PMID 22623692, PMID 22649152, PMID 22967996, PMID 23632474, PMID 23953056, PMID 24323026, PMID 25287822, PMID 26834058, PMID 26874901, PMID 27078022, PMID 27406346, PMID 27406347, PMID 27713176, PMID 28274957, PMID 28302091, PMID 28851423, PMID 29146401, PMID 30689703, PMID 30813966, PMID 30860945, PMID 30867034, PMID 31140297, PMID 31442103, PMID 31548342, PMID 31558424, PMID 31796073, PMID 32031889, PMID 32053137, PMID 32450725, PMID 32464281, PMID 32678716, PMID 32701140, PMID 32723675, PMID 32919527, PMID 32923853, PMID 33203645, PMID 33663941, PMID 33796451, PMID 33893289, PMID 34482636, PMID 34529000, PMID 34553296, PMID 34741021
2019 (3), 2015 (1), K12CA001727 (1), P30CA033572 (1), R01CA273246 (1), U10CA180820 (1), U10CA180868 (1), UM1CA186689 (1)