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No major adverse effects related to the use of Soyselect® have been observed during clinical trials in comparison with placebo and in pharmacokinetics studies.
Soyselect® safety profile has been determined in studies performed in rats aimed at evaluating 30-day oral toxicity and the effects on reproductive functions (1,2).
In two animal studies, Soyselect®, orally administered at 50 and 100 mg/kg/day, was proven devoid of effects on the growth of estrogen-dependent human breast cancer xenograft in ovariectomized athymic mice (chart 1) and on the growth of estrogen-unresponsive human breast cancer xenograft in athymic mice (3). Click here to download the complete poster.
However a most recent study (4)
indicate that concomitant administration of 50mg/kg/day of Soyselect® in mice carrying estrogen-dependent breast cancer have slightly potentiated the effect of the estrogen antagonist fulvestrant drug, whereas a dose of 100 mg/kg/day partially negated the tumor reduction activity of the same drug.
It is advisable not to recommend the consumption of isoflavone supplements in conjunction of fulvestrant therapy in post menopausal women with estrogen-dependent breast cancer.
(1) Report Dipartimento di Scienze Mediche - Trieste, November 4, 1997 - Indena S.p.A., Internal File.
(2) Report Sta /03/97 - Indena S.p.A., Internal File.
(3) Gallo D., Ferlini C., Fabrizi M., Prislei S., Riva A., Morazzoni P., Bombardelli E., Scambia G., 6th International Symposium on the Role of Soy, 30 October - 2 November 2005, Chicago, USA.
(4) Gallo D., Mantuano E., Fabrizi M., Ferlini C., Mozzetti S., De Stefano I., Scambia G., Endocrine-Related Cancer. 2007, 14, pag. 317-324
