. Author manuscript; available in PMC: 2021 Apr 6.

Published in final edited form as: Nat Rev Clin Oncol. 2019 Dec 13;17(4):233–250. doi: 10.1038/s41571-019-0299-9

Table 5 |.

Key phase II–III trials of CDK4/6 inhibitors or immunotherapies combined with anti-HER2 therapy

Clinical trial	Phase	HR status	Treatment setting	Anti-HER2 therapy	Concurrent therapies	Results
*CDK4/6 inhibitors*
NA-PHER2 (NCT02530424)¹⁷⁰	II	ER+	Neoadjuvant	T+P	Palbociclib ± fulvestrant	pCR rate 27%; mean Ki67 index 31.9 at baseline vs 4.3 at week 2 (n = 25; P <0.0001) and 12.1 at surgery (n = 22, P = 0.013)
PALTAN (NCT02907918)	II	ER+	Neoadjuvant	T	Palbociclib + letrozole (+ goserelin in premenopausal women)	Ongoing (recruiting)
PATRICIA 2 (NCT02448420)¹⁷¹	II	ER+	Metastatic	T	Palbociclib ± letrozole	Ongoing (recruiting)
PATINA (NCT02947685)¹⁷²	III	ER+	Metastatic	T+P	Palbociclib + endocrine therapy	Ongoing (recruiting)
monarcHER (NCT02675231)¹⁷³	II	ER+	Metastatic	T	Abemaciclib ± fulvestrant	Ongoing (active, not recruiting)
NCT03530696	II	ER+ or ER−	Metastatic	T-DM1	Palbociclib	Ongoing (recruiting)
TOUCH (NCT03644186)	II	ER+	Neoadjuvant	T+P	Palbociclib + letrozole	Ongoing (recruiting)
*Immune-checkpoint inhibitors*
PANACEA (NCT02129556)¹⁷⁴	I/II	ER+ or ER−	Metastatic	T	Pembrolizumab	Objective response achieved in 6 (15) of 40 patients with PD-L1-positive disease, but none in patient with PD-L1-negative disease
neoHIP (NCT03747120)¹⁷⁵	II	ER+ or ER−	Neoadjuvant	T+P	Pembrolizumab	Ongoing (recruiting)
NCT03199885	III	ER+ or ER−	Metastatic	T+P	Atezolizumab	Ongoing (recruiting)
NCT03417544	II	ER+ or ER−	Metastatic	T+P	Atezolizumab	Ongoing (recruiting)

For some trials, ER status actually reflects the hormone receptor status (that is, positive or negative for ER and/or progesterone receptor expression). ER, oestrogen receptor; HR, hormone receptor; n, number of patients; P, pertuzumab; pCR, pathological complete response; PD-L1, programmed cell death 1 ligand 1; T, trastuzumab.