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