Table 2.
Selected recent ongoing and completed phase II/III clinical trials of inhibitors of HER family receptors in combination with endocrine therapy
| Trial design | Disease setting | Trial phase | Primary endpoints | Outcomes |
|---|---|---|---|---|
| Gefitinib | ||||
| Tamoxifen ± gefitinib | Metastatic | II RCT | TTP | Completed |
| Anastrazole ± gefitinib (178) | Neoadjuvant | II RCT | ORR | NS ORR favoring the AI alone instead of the combination |
| Gefitinib ± anastrazole (169)a | Neoadjuvant | II RCT | ↓ Ki67 labeling index | ↓ Ki67 labeling index 98% vs. 92.4% |
| ↓ in tumor size | ↓ in tumor size no difference | |||
| Gefitinib ± anastrazole | Metastatic | II RCT | TTP | Ongoing |
| Gefitinib + anastrazole vs. gefitinib + fulvestrant | Metastatic | II RCT | ORR | Ongoing |
| Lapatinib | ||||
| Lapatinib + tamoxifen | Metastatic 2nd line | II | ORR/CBR | Ongoing |
| Lapatinib ± letrozole | Metastatic | III RCT | TTP | Ongoing |
| Lapatinib ± fulvestrant | Metastatic | II RCT | ORR/PK | Ongoing |
| Trastuzumab | ||||
| Trastuzumab + letrozole (176) | Metastatic | II | ORR/TTP | ORR 26% |
| TTP 5.5 months | ||||
| Anastrazole vs. anastrazole + trastuzumab (177) | Metastatic | III | ORR/TTP | TTP 2.4 months vs. 4.8 months |
| ORR 6.8% vs. 20.3% | ||||
| Trastuzumab + exemestane | Metastatic | II | TTP | Completed |
RCT, Randomized controlled trial; ORR, objective response rate; CBR, clinical benefit rate; NS, not significant; Tam, tamoxifen; PK, pharmacokinetics. Also see information in Johnston et al. (83).
a
Only in EGFR-positive patients.