Table 3.
Clinical trials of pyrotinib in HER2 breast cancer treatment
| NCT Number | Study Type | Trial Arm | Subjects | Patients | Status | Location |
|---|---|---|---|---|---|---|
| NCT01937689 | I | Pyrotinib | 40 | HER2-positive advanced breast cancer | Completed | China |
| NCT02361112 | I | Pyrotinib + capecitabine | 38 | HER2-positive metastatic breast cancer | Completed | China |
| NCT02500199 | I | Pyrotinib | 50 | HER2-positive advanced solid tumors, including breast cancer, non-small cell lung cancer | Recruiting | USA |
| NCT03772353 | I/II | Pyrotinib + letrozole + SHR6390 | 32 | HER2-positive and HR-positive relapsed or metastatic breast cancer | Recruiting | China |
| NCT02422199 | I/II | Pyrotinib + capecitabine vs lapatinib + capecitabine | 128 | HER2-positive metastatic breast cancer | Active, not recruiting | China |
| NCT03805399 | I/II | Pyrotinib + capecitabine | 140 | Luminal androgen receptor subtype triple-negative and HER2 mutation breast cancer | Recruiting | China |
| NCT04001621 | II | Pyrotinib + capecitabine | 100 | HER2-positive advanced breast cancer with Trastuzumab-resistant | Recruiting | China |
| NCT03923179 | II | Pyrotinib + etoposide | 32 | HER2-positive advanced breast cancer | Recruiting | China |
| NCT03993964 | II | Pyrotinib + CDK4/6 Inhibitor | 20 | HER2-positive metastatic breast cancer | Not yet recruiting | China |
| NCT03933982 | II | Pyrotinib + vinorelbine | 30 | HER2-positive CNS metastatic breast cancer | Recruiting | China |
| NCT03919253 | II | Pyrotinib + nab-paclitaxel | 80 | HER2-positive advanced breast cancer | Not yet recruiting | China |
| NCT03735966 | II | Pyrotinib + trastuzumab + docetaxel | 51 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| NCT03923166 | II | Pyrotinib+ capecitabine | 35 | HER2-positive advanced breast cancer | Recruiting | China |
| NCT03691051 | II | Pyrotinib + capecitabine | 102 | HER2-positive metastatic breast cancer | Not yet recruiting | China |
| NCT03997539 | II | Pyrotinib + vinorelbine vs Treatment of Physician’s Choice | 256 | HER2-positive locally advanced or metastatic breast cancer | Not yet recruiting | China |
| NCT03412383 | II | Pyrotinib | 14 | HER2 non-amplified but HER2 mutant metastatic breast cancer | Recruiting | China |
| NCT03876587 | II | Pyrotinib + docetaxel | 79 | HER2-positive metastatic breast cancer | Not yet recruiting | China |
| NCT03910712 | II | Pyrotinib+ trastuzumab + aromatase inhibitor vs trastuzumab + aromatase inhibitor | 250 | HER2-positive and HR-positive metastatic or inoperable locally advanced breast cancer | Not yet recruiting | China |
| NCT03980054 | III | Pyrotinib vs placebo | 1192 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| NCT03080805 | III | Pyrotinib + capecitabine vs Lapatinib + capecitabine | 240 | HER2-positive metastatic breast cancer | Recruiting | China |
| NCT02973737 | III | Pyrotinib + capecitabine vs placebo + capecitabine | 350 | HER2-positive early stage or locally advanced breast cancer | Active, not recruiting | China |
| NCT03588091 | III | Pyrotinib + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel | 294 | HER2-positive early stage or locally advanced breast cancer | Recruiting | China |
| NCT03863223 | III | Pyrotinib + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel | 590 | HER2-positive metastatic breast cancer | Not yet recruiting | China |
| NCT03908749 | - | Pyrotinib | 300 | HER2-positive advanced breast cancer | Not yet recruiting | China |
| NCT03947242 | Not Applicable | Pyrotinib + trastuzumab + vinorelbine | 48 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| NCT03847818 | Not Applicable | Pyrotinib + trastuzumab + docetaxel + carboplatin | 268 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| NCT03756064 | Not Applicable | Pyrotinib + trastuzumab + docetaxel + carboplatin vs placebo + trastuzumab + docetaxel + carboplatin | 100 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900022844 | I | Pyrotinib + different chemotherapy regimens | 60 | HER2 positive advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900022557 | I | Pyrotinib + chemotherapy | 40 | HER 2-positive and HR low-positive/negative advanced recurrent/metastatic breast cancer | Not yet recruiting | China |
| ChiCTR1800020217 | II | Epirubicin + cyclophosphamide + pyrotinib + sequential docetaxel + trastuzumab + pyrotinib | 60 | HER2-positive early stage or locally advanced breast cancer | Recruiting | China |
| ChiCTR1900023653 | II | Pyrotinib + paclitaxel(albumin-binding) | 55 | HER2 positive advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900022293 | III | Epirubicin + cyclophosphamide + pyrotinib + trastuzumab vs epirubicin + cyclophosphamide + trastuzumab | 210 | Stage I to III HER2-positive breast cancer | Not yet recruiting | China |
| ChiCTR1800020226 | III | Pyrotinib + trastuzumab + carboplatin + docetaxel vs trastuzumab + carboplatin + docetaxel | 336 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900021819 | IV | Pyrotinib | 1000 | HER2-positive locally advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900020670 | IV | Pyrotinib + standard treatment | 48 | HER2-positive brain metastatic breast cancer | Not yet recruiting | China |
| ChiCTR1800020449 | IV | Pyrotinib + trastuzumab + paclitaxel + cisplatin | 40 | HER2-positive early stage or locally advanced breast cancer | Not yet recruiting | China |
| ChiCTR1900023152 | IV | Pyrotinib | 60 | HER2 positive advanced breast cancer | Not yet recruiting | China |