Current Strategies of Endocrine Therapy in Elderly Patients with Breast Cancer

Table 5

Clinical trials of palliative endocrine therapy in elderly patients with breast cancer.

Study	Design	Number of patients	Treatment	Primary end point	Results
First line
TARGET [14]	Phase 3, randomized, double-blind	668	Anastrozole 1 mg versus tamoxifen 20 mg	TTP; OR	8.2 versus 8.3 mths, HR 0.99; 32.9 versus 32.6%	0.941; 0.787
Nabholtz et al. [15]	Phase 3, randomized, double-blind	353	Anastrozole 1 mg versus tamoxifen 20 mg	TTP; OR	11.1 versus 5.6 moths HR, 1.44; 21 versus 17%	0.005
Paridaens et al. [16]	Phase 3, randomized, open-label	371	Exemestane 25 mg versus tamoxifen 20 mg	PFS	HR 0.84, 95% CI 0.67–1.05	0.121
Mouridsen et al. [17]	Phase 3, randomized, double-blind	916	Letrozole 2.5 mg versus tamoxifen 20 mg	TTP	9.4 versus 6.0 moths, HR 0.72	<0.0001
PALOMA-1/TRIO-18 [18]	Phase 2, open-label, randomized	165	Letrozole 2.5 mg versus letrozole 2.5 mg + palbociclib 125 mg	PFS	10.2 versus 20.2 mths, HR 0.488	≤0.001
FIRST [19]	Phase 2, open-label, randomized	205	Fulvestrant 500 mg versus anastrozole 1 mg	CBR	72.5 versus 67%	0.386
Second line
BOLERO-2 [20]	Phase 3, randomized, double-blind	724	Everolimus 10 mg + exemestane 25 mg versus exemestane 25 mg	PFS	6.9 versus 2.8 mths, HR 0.43	<0.001
PALOMA3 [21]	Phase 3, randomized, double-blinded	521	Palbociclib 125 mg + fulvestrant 500 mg versus. fulvestrant 500 mg	PFS	9.2 versus 3.8 mths, HR 0.42	<0.001

No, number; TTP, time to progression; OR, objective response; mths, month; HR, hazard ratio; PFS, progression-free survival; CBR, clinical benefit rate (proportion of patients with objective response or stable disease for ≥24 weeks).