Table 2:
Ongoing trials of anti- ErbB family drugs (excluding HER2− selective therapies) in breast cancer
| NCT Identifier | Phase | Drug | Target | Combination therapy | Drug class | Population | Primary endpoint |
|---|---|---|---|---|---|---|---|
| NCT02980341 | I/II | U3–1402 | HER3 | - | ADC | HER3+ | Safety |
| NCT04699630 | II | U3–1402 | HER3 | - | ADC | MBC | ORR and PFS6 |
| NCT04965766 | II | U3–1402 | HER3 | - | ADC | MBC | ORR |
| NCT04610528 | I Pre-surgery (WoO) |
U3–1402 | HER3 | - | ADC | mRNA-ERBB3 expressed eBC | CelTIL score |
| NCT04460430 | II | Neratinib | EGFR/HER3/HER4 | Fulv/TAM/EXE | TKI | HR+/HER2− /HER2 mutant MBC | PFS |
| NCT05154396 | II | Neratinib escalating dose | EGFR/HER3/HER4 | - | TKI | HR+/HER2−/HER4+ eBC (neadj) | Safety |
| NCT04965064 | II | Neratinib | EGFR/HER3/HER4 | Capecitabine | TKI | BM HER2− with HER2 CELsignia + | OS |
| NCT03065387 | II | Neratinib | HER2/EGFR | Palbociclib or Trametinib or everolimus | TKI | HER2 mutant | Safety of the combination |
| NCT04872985 | II | Pyrotinib | panErbB | - | TKI | HR+/HER2−/HER4+ eBC (neadj) | tpCR |
| NCT04582968 | II | Pyrotinib | panErbB | + RT | TKI | HER2+ MBC with BM | Safety CNS |
| NCT04001621 | II | Pyrotinib | panErbB | - | TKI | HER2+ MBC | PFS |
| NCT04681911 | II | Pyrotinib | panErbB | Inetetamab (ADC) + Chemo | TKI | HER2+ MBC | ORR |
| NCT04481932 | II | Pyrotinib | panErbB | TCbH | TKI | HER2+ early BC (neadj) | tpCR |
| NCT04255056 | II | Pyrotinib | AC | ||||
| NCT04646759 | III | Pyrotinib | panErbB | Fulvestrant | TKI | HR+/HER2+ MBC | PFS |
| NCT05255523 | II | Pyrotinib | panErbB | Trastuzumab | TKI | 2L HER2+ MBC | Incidence of first BM event |
| NCT04973319 | III | Pyrotinib | panErbB | Sequentially after HP | TKI | Non-pCR patient (post-neoad) | IDFS |
| NCT03321981 | II | MCLA-128 | HER3 | ET or H/Chemotherapy | TKI | HR+ or HER2+ | CBR 24w |
Note: ORR: overall response rate; ET: endocrine therapy; CBR 24w: clinical benefit rate at 24 weeks; CNS: central nervous system; TKI: tyrosine kinase inhibitor; ADC: antibody drug conjugate; tpCR: total pathological complete response; CNS: central nervous system; FULV: fulvestrant; TAM: tamoxifen; eBC: early breast; WoO: window of opportunity; CelTIL: tumor cellularity and TILS; BM: brain metastasis; HR: hormone receptor; EXE: exemestane; TCbH: Taxotere, Carboplatin, Herceptin; AC: adriamycin and cyclophosphamide; mTNBC: metastatic triple negative breast cancer; IDFS: invasive disease-free survival; HP: trastuzumab and pertuzumab
https://clinicaltrials.gov/ (last update on 4/05/2022)