Table 3.

Select additional preclinical and clinical studies of novel agents for breast cancer prevention.

Trial/experiment	Study design	Treatment group characteristics	Results/primary endpoint(s)
EGFR INHIBITORS
Chan et al. (69)	Gefitinib vs. placebo	Transplant of DCIS tissue in immuno-suppressed mice	56% Reduction in proliferation, measured by Ki67
Lu et al. (46)	Gefitinib (low and high dose) vs. placebo	MMTV-Erb2 mice	High dose gefitinib showed a delay in ER-negative tumor development
Piechocki et al. (70)	Gefitinib vs. placebo	MMTV-Erb2 mice	Reduction in number and size of tumors
Strecker et al. (45)	Lapatinib (low and high dose) vs. placebo	MMTV-Erb2 mice	High dose lapatinib showed a delay in ER-negative tumor development
REXINOID
Li et al. (57)	LG100268 (low and high dose) vs. placebo	MMTV-Erb2 mice	Low dose: delay in ER-negative tumor development
			High dose: prevented ER-negative tumor development in 90% of mice
COX-2 INHIBITORS
Fabian et al. NCT00056082	Celecoxib vs. placebo	110 Premenopausal women at high-risk for ER-negative BC	Proliferation: Ki67 IHC staining
Arun et al. N01-CA-9757	Exemestane ± celecoxib	44 Pre- and post-menopausal high-risk women	Proliferation: Ki67 IHC staining
Wong et al. NCI-04-0044	Exemestane ± celecoxib	72 Postmenopausal high-risk women	Mammographic breast density
METFORMIN
Anisimov et al. (72)	Metformin vs. placebo	MMTV-Erb2 mice	Delay in ER-negative tumor development
MTOR INHIBITORS
Torres-Arzayus et al. (73)	Everolimus vs. placebo	AIB Mice	Reversion of pre-malignant phenotype
Kim et al. (74)	Rapamycin vs. vehicle	Benign, pre-malignant, and breast cancer cell lines	Most effective in benign and pre-malignant cells
Mercier et al. (75)	Rapamycin vs. vehicle	Cav-1 knockout mice	Tumor growth inhibition; decreased stromal content
IGF-R INHIBITORS
Litzenburger et al. (76)	BMS-754807 vs. placebo	MCF10A	Growth inhibition in a pre-malignant cell line transformed by IGF1R

BC, breast cancer; DCIS, ductal carcinoma in situ; ER, estrogen receptor; IHC, immunohistochemical staining.