Table 3.
Main trials ongoing in HER2−low breast cancer
| Type of drug | Drugs tested | NCT | Phase | Status | Population | Primary endpoints |
|---|---|---|---|---|---|---|
| Advanced breast cancer | ||||||
| ADC | T-DXd + pembrolizumab | NCT04042701 | lb | Recruiting | HER2−positive and HER2−low BC | MTD, ORR |
| T-DXd + durvalumab | NCT03742102 | lb/11 | Recruiting | HER2−low TNBC | AEs | |
| T-DXd + durvalumab + paclitaxel + ET | NCT04556773; DESTINY-Breast08 | lb (module 2) | Recruiting | HER2−low BC | AEs | |
| T-DXd versus TPC | NCT04494425; DESTINY-Breast06 | III | Recruiting | HER2−low and HR + BC | PFS | |
| MRG002 | NCT04742153 | II | Recruiting | HER2−low BC | ORR | |
| RC48-ADC | NCT04400695 | III | Recruiting | HER2−low bc | PFS | |
| RC48-ADC | NCT05331326 | II | Recruiting | HER2−expressng BC | ORR | |
| SYD985 + paclitaxel | NCT04602117;ISPY-P1 | I/IIb | Recruiting | HER2−positive and HER2−low BC | AEs, CBR, ORR | |
| ARX788 | NCT02512237; ACE-Breast03 | II | Recruiting | HER2−positive and HER2−low BC | ORR | |
| ARX788 | NCT03255070 | Recruiting | HER2−positive tumors | AEs, ORR | ||
| ARX788 | NCT05018676 | II | Recruiting | HER2−low BC | ORR | |
| RC48-ADC | NCT03052634 | lb | Active, not recruiting | HER2−positive and HER2−low BC | RP2D | |
| RC48-ADC versus TPC | NCT04400695 | III | Recruiting | HER2−low BC | PFS | |
| A166 | NCT03602079 | I/II | Active, not recruiting | HER2−positive tumors | DLT | |
| BAY2701439 | NCT04147819 | Recruiting | HER2−positive tumors | AEs | ||
| FS-1502 | NCT03944499 | Recruiting | HER2−positive tumors | AEs | ||
| Bi/trispecific antibody | MCLA-128 | NCT03321981 | II | Active, not recruiting | HER2−positive and HR+/HER2−low tumors | CBR at 24 weeks |
| Zanidatamab | NCT02892123 | Active, not recruiting | HER2−expressing cancer | rate of DLT | ||
| Runimotamab | NCT03448042 | Recruiting | HER2−expressing cancer | rate of AEs | ||
| IBI315 | NCT04162327 | Recruiting | HER2−expressing cancer | AUC,t1/2,Vd,Cmax | ||
| SAR443216 | NCT05013554 | Recruiting | HER2−expressing cancer | MTD, rate of AEs | ||
| mAB | IMM2902 | NCT05076591 | Recruiting | HER2−expressing cancer | DLT, MTD, AEs | |
|
| ||||||
| Early breast cancer | ||||||
| Vaccine | AST-301, pNGVL3-hlCD | NCT05163223 | II | Recruiting | HER2−low BC | 2 yr iDFS |
| TKI inhibitor | Pyrotinib | NCT05165225 | II | Recruiting | HR+/HER2−low BC | pCR |
| ADCs | T-Dxd + Anastrozole | NCT04553770 | II | Recruiting | HR+/HER2−low BC | pCR |
| T-Dxd | NCT04132960 (DAISY) | II | Active, not recruiting | HER2+, HER2−low, and HER2 0 B C | Antitumor activity | |
ADC, antibody drug conjugates; AEs, adverse events; AUC, area under the plasma concentration-time curve; bc, breast cancer; BOR, best overall response; CBR, clinical benefit rate; Cmax, Maximum plasma concentration; DLT, dose limiting toxicity; iDFS, invasive disease free survival; mAB, monoclonal antibody; MTD, maximum tolerated dose; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RP2D, recommended phase II dose; TKI, tyrosine kinase inhibitors; T1/2, Terminal elimination half-life; Vd, apparent volume of distribution; pCR, pathological complete response.