Table 4.

Ongoing pertuzumab clinical trials

Treatment setting	Trial	Phase	Treatment groups	Primary end point	Target enrollment	Estimated completion	Comments
Neoadjuvant	Opti-HER Heart51 (NCT01669239)	II	Liposomal doxorubicin + paclitaxel + T + P	Cardiac safety	83	2015
	NCT0179619752	II	Paclitaxel + T + P	pCR	30	2015	Inflammatory
Adjuvant	Aphinity53 (NCT01358877)	III	1. Chemo + T + P 2. Chemo + T	DFS	4,800	2023
Metastatica	NCT0127604154	II	Paclitaxel + T + P	6 month PFS	69	2014
	VELVET55 (NCT01565083)	II	Vinorelbine + T + P	ORR	210	2015
	PERTAIN56 (NCT01491737)	II	1. AI + T + P 2. AI + T 3. Chemo + T + P→AI + T + P 4. Chemo + T→AI + T	PFS	250	2016
	MARIANNE57 (NCT01120184)	III	1. T-DM1 + P 2. T-DM1 3. Taxane + T	1. PFS 2. AEs	1,095	2016
	NCT0173083358	II	Nab-paclitaxel + T + P	PFS	45	2017
	PERUSE59 (NCT01572038)	IIIb	Taxane + T + P	Safety	1,500	2018
	HELENA60 (NCT01777958)	II	T + P	PFS	478	2020	Postadjuvant T
	NCT0159741461	II	1. Metronomic chemo + T + P 2. T + P	PFS	80	NR	Elderly
	PHEREXA62 (NCT0126142)	II	1. Capecitabine + T + P 2. Capecitabine + T	PFS	450	2017

Note:

^aAll trials in first-line setting except PHEREXA, which is second-line.

Abbreviations: T, trastuzumab; P, pertuzumab; pCR, pathologic complete response; chemo, chemotherapy; DFS, disease-free survival; PFS, progression-free survival; ORR, overall response rate; AI, aromatase inhibitor; T-DM1, trastuzumab emtansine; AEs, adverse effects.