Table 1:

Active clinical trials in metastatic breast cancer expanding the use of palbociclib to HER2-positive or triple-negative subtypes.

Name/Identifier	Phase	Subtype	Setting	Interventions	Primary Outcome Measures
NCT02530424 NA-PHER2	II	HER2+	NA	Palbociclib, trastuzumab, pertuzumab and fulvestrant	Serial measures of Ki67 Serial measures of apoptosis
NCT02907918 PALTAN	II	HER2+	NA	Palbociclib, letrozole, trastuzumab and goserelin if pre-menopausal	Rate of pCR
NCT03644186 TOUCH	II	HER2+	NA	Palbociclib, letrozole, trastuzumab and pertuzumab vs. paclitaxel, trastuzumab and pertuzumab	Rate of pCR
NCT01976169	I	HER2+	M	Palbociclib and T-DM1	Maximum tolerated dose Dose-limiting toxicities
NCT03054363	I/II	HER2+	M	Palbociclib, letrozole and tucatinib	Adverse events at 2.5 years Progression-free survival at 2.5 years
NCT03304080	I/II	HER2+	M	Palbociclib, anastrozole, trastuzumab and pertuzumab	Maximum tolerated dose Dose-limiting toxicities Clinical benefit rate
NCT03709082	I/II	HER2+	M	Palbociclib, letrozole and T-DM1	Rate of overall response at 5 years
NCT02448420 PATRICIA II	II	HER2+	M	Palbociclib and trastuzumab ± endocrine therapy Palbociclib, trastuzumab, and endocrine therapy vs. trastuzumab, T-DM1, and chemotherapy	PFS
NCT03530696 T-DM1	II	HER2+	M	T-DM1 ± palbociclib	PFS
NCT02947685 PATINA	III	HER2+	M	Trastuzumab, pertuzumab and endocrine therapy ± palbociclib	PFS
NCT02605486	I/II	TN (AR+)	M	Palbociclib and bicalutamide	Recommended phase II dose PFS

Abbreviations: (AR+) Androgen receptor-positive; (HER2+) HER2-positive; (M) Metastatic; (NA) Neoadjuvant; (pCR) Pathological complete response; (PFS) Progression-free survival; (T-DM1) Trastuzumab emtansine; (TN) Triple-negative