Therapeutic options for HER-2 positive breast cancer: Perspectives and future directions

Table 3 Selected clinical trials in metastatic human epidermal growth factor receptor-2 positive breast cancer

Drug or study name	Population included	No. ofpatients	Comparison	MedianOS (mo)	MedianTTP (mo)	ORR	1-yr Survival	Ref.
Single agents
Trastuzumab (H)	Phase II, first line, MBC	114	None-2 doses of H used	24.4	3.8	26% (18%-34%)	N/A (approximat- ely 65%)	Vogel et al[45]
Ado-trastuzumab	Phase II, refractory MBC	110	None	N/A	6.9 (4.2–8.4)	34% (26%-44%)	N/A	Krop et al[48]
Anti-HER-2 + QT
H + Paclitaxel (T)	Phase III, first line, MBC	469	QT (AC or T) + H vs QT	25.1 vs 20.3	7.4 vs 4.6	50% vs 32%	78% vs 67%	Slamon et al[44]
Cont. Anti-HER-2 after failing 1st line
Lapatinib (L)	Phase III, failed to H	324	Cape + L vs Cape alone	N/A	8.4 vs 4.4	22% vs 14%	N/A (approximat- ely 60%)	Geyer et al[54]
EMILIA Trial (Ado-trastuzumab)	Phase III, MBC who failed TH	991	Ado-T vs Cape + L	30.9 vs 25.1	9.6 vs 6.4	43.6% vs 30.8%	85% vs 78%	Verma et al[55]
Dual Anti-HER-2
CLEOPATRA	Phase III, first line, MBC	808	Do + H + P vs Do + H	Not reached	18.5 vs 12.4	80% vs 69%	N/A (approximat- ely 90%-95%)	Baselga et al[57]
Lap + Trastuzumab	Phase III, failed to H	296	L + H vs L alone	11.8 vs 8.9	2.75 vs 1.85	10% vs 7%	70% vs 36%	Blackwell et al[59]
H + Pertuzumab (P)	Phase II, failed to H	66	None-H + P single arm	N/A	5.5	24.20%	N/A	Baselga et al[61]
Anti-HER-2 + AI
Anastrozole + H	Phase III, HR and HER-2 positive, 1st line in MBC	207	Anastrozole + H vs Anastrozole alone	28.5 vs 23.9	4.8 vs 2.4	20% vs 6.8%	N/A (approximat- ely 78%)	Kaufman et al[63]
Letrozole + L	Same	219	Letrozole + L vs Letrozole alone	33.3 vs 32.3	8.2 vs 3.0	28% vs 15%	N/A	Johnston et al[64]

QT: Chemotherapy; AI: Aromatase Inhibitor; MBC: Metastatic breast cancer; HR: Hormones receptor; Do: Docetaxel; AC: Adriamycin cyclophosphamide; T: Paclitaxel; OS: Overall survival; TTP: Time to progression; N/A: Not available or not reported.