Table 4.
Ongoing clinical trials on TKIs for breast cancer as of March 20, 2023
| Registration no. | Status | Cancer type | Study title | Trial phase | No. of subjects | Country |
|---|---|---|---|---|---|---|
| NCT03289039 | Active, not recruiting | HER2-positive, ER-positive metastatic breast cancer | A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer | Phase 2 | 21 | The US |
| NCT05388149 | Not yet recruiting | HER2-positive breast cancer | Kadcyla And Neratinib for Interception of HER2 + Breast Cancer With Molecular Residual Disease | Phase 2 | 15 | Canada |
| NCT04965064 | Not yet recruiting | HER2-negative metastatic breast cancer | Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling | Phase 2 | 22 | The US |
| NCT04366713 | Completed | HER2 amplified breast cancer | A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib | Phase 2 | 6 | Portugal |
| NCT04460430 | Recruiting | HR-Positive/HER2-negative HER2-enriched advanced/metastatic breast cancer | Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer | Phase 2 | 56 | Multinational |
| NCT05154396 | Not yet recruiting | HER2 positive early breast cancer | Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer | Phase 2 | 60 | China |
| NCT03377387 | Active, not recruiting | Metastatic HER2-positive breast cancer | Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | Phase 1/2 | 34 | The US |
| NCT02673398 | Active, not recruiting | Stage IV HER2-positive breast cancer | Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | Phase 2 | 25 | The US |
| NCT05252988 | Not yet recruiting | Early-stage HER2+, HR + breast cancer | Trial to Evaluate Diarrhoea Discontinuations at 3 Cycles in Patients With Early-stage HER2+, HR + Breast Cancer Treated With Neratinib Plus Loperamide Versus Neratinib Dose Escalation Plus Loperamide Administered as Needed Versus Neratinib Plus Loperamide Plus Colesevelam (DIANER) | Phase 2 | 315 | Spain |
| NCT05243641 | Recruiting | Metastatic breast cancer | Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER2 and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test | Phase 1/2 | 56 | The US |
| NCT04886531 | Not yet recruiting | Triple positive breast cancers | Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers | Phase 2 | 48 | The US |
| NCT04901299 | Not yet recruiting | Breast cancer | Fulvestrant + Neratinib In Breast Cancer | Phase 2 | 25 | The US |
| NCT03812393 | Recruiting | Triple negative breast cancer | Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | Phase 2 | 27 | The US |
| NCT04388384 | Recruiting | Breast cancer | Real-life Pan-HER-blockade With Neratinib (ELEANOR) | Phase 2 | 200 | Germany |
| NCT03101748 | Active, not recruiting | Metastatic or locally advanced breast cancer | Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer | Phase 1/2 | 43 | The US |
| NCT04760431 | Not yet recruiting | HER2 + breast cancer | TKIs vs. Pertuzumab in HER2 + Breast Cancer Patients With Active Brain Metastases (HER2BRAIN) | Phase 2 | 120 | China |
| NCT05491057 | Not yet recruiting | HER2-positive Early-stage Breast Cancer | Treatment Patterns of Neratinib in HER2 + EBC in China | / | 500 | China |
| NCT05599334 | Recruiting | Early-stage HER2-positive Breast Cancer | A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib | / | 130 | Belgium |
| NCT03182634 | Recruiting | Advanced Breast Cancer | The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial | Phase 2 | 1150 | The UK |
| NCT05760612 | Recruiting | Hormone Receptor Positive HER2 -Positive Breast Cancer | A Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment With Trastuzumab Combined With Parezumab | Phase 3 | 300 | China |
| NCT05834764 | Recruiting | HER2-positive Breast Cancer | Pyrotinib in Women With High-risk in Early Stage Breast Cancer | Phase 2 | 188 | China |
| NCT04605575 | Recruiting | HER2-positive Breast Cancer | Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer | Phase 2 | 208 | China |
| NCT05076695 | Recruiting | Hormone Receptor Positive HER2 -Positive Breast Cancer | Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer (NeoTPPF) | Phase 2 | 37 | China |
| NCT04481932 | Recruiting | HER2-positive Breast Cancer | Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer | Phase 2 | 104 | China |
| NCT05346861 | Recruiting | HER2-positive Breast Cancer | Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab | Phase 3 | 240 | China |
| NCT05748834 | Recruiting | HER2 + Metastatic Breast Cancer | Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer | Phase 2 | 36 | The US |
| NCT03975647 | Recruiting | HER2-positive Breast Cancer | A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2 + Breast Cancer | Phase 3 | 565 | Multinational |
| NCT05230810 | Recruiting | HER2-positive Metastatic Breast Cancer | Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2 + Metastatic Breast Cancer | Phase 1/2 | 40 | The US |
| NCT04539938 | Recruiting | HER2-Positive Breast Cancer | A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2 + Breast Cancer (HER2CLIMB-04) | Phase 2 | 70 | The US |
| NCT04789096 | Recruiting | HER2-Positive Breast Cancer | Tucatinib Together With Pembrolizumab and Trastuzumab (TUGETHER) | Phase 2 | 50 | Australia |