Table 3.
Ongoing trials with CDK 4/6 inhibitors and anti HER2 blockade and hormonal therapy in metastatic breast cancer.
| CDK 4/6 inhibitor | Phase study | Population | Study end point | Treatment arm | ClinicalTrials.gov number |
|---|---|---|---|---|---|
| Palbociclib | I/II | Up to 1 previous line of anti HER2 therapy | The number of patients in the phase Ib part of the study with any adverse events (AE). PFS (phase II part) |
Tucatinib + Palbociclib + letrozole | NCT 3054363 |
| Palbociclib | II | 2–4 previous lines of HER2 therapy | PFS at 6 months | Palbociclib + trastuzumab +/– letrozole | NCT 02448420 |
| Palbociclib | I/II | First line advanced HER2 positive | DLT MTD CBR |
Palbociclib + trastuzumab + pertuzumab + anastrozole | NCT 03304080 |
| Ribociclib | Ib/II | Cohort A: at least one previous line of anti HER2 therapy B at least trastuzumab, pertuzumab, TDM1 |
MTD or Recommended phase II Dose (RP2D) CBR |
A Ribociclib + TDM1 B Ribociclib + trastuzumab |
NCT 02657343 |
| Abemaciclib | II | At least 2 lines anti HER2 therapy | PFS | Abemaciclib + trastuzumab + fulvestrant versus
Abemaciclib + trastuzumab versus trastuzumab + chemotherapy |
NCT 02675231 |
CBR, clinical benefit rate; DLT, dose-limiting toxicity; MTD, maximum tolerated dose; PFS, progression free survival.