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Clinical development of estrogen modulators for breast cancer chemoprevention in premenopausal vs. postmenopausal women
Author(s) -
Lawrence Julia A.,
Malpas Phyllis B.,
Sigman Caroline C.,
Kelloff Gary J.
Publication year - 2000
Publication title -
journal of cellular biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 165
eISSN - 1097-4644
pISSN - 0730-2312
DOI - 10.1002/(sici)1097-4644(2000)77:34+<103::aid-jcb17>3.0.co;2-0
Subject(s) - medicine , estrogen , tamoxifen , breast cancer , clinical trial , biomarker , oncology , hormone , menopause , cancer , biology , biochemistry
Abstract Tamoxifen has proven to be beneficial in the chemoprevention of breast cancer in women at increased risk for the disease. Other compounds that mediate the estrogen pathway remain to be tested for clinical efficacy. The mechanism of action, efficacy, and dose response of the estrogen modulators is determined by the hormonal milieu of the host which should be considered in the early clinical trials for dose range finding studies and surrogate endpoint biomarker (SEB) evaluation. This review presents the hormonal effects to consider in the clinical testing of an agent in premenopausal vs. postmenopausal cohorts. Recommended SEBs that may be evaluated in Phase I/II clinical trials of estrogen modulators for breast cancer chemoprevention are presented. J. Cell. Biochem. Suppl. 34:103–114, 2000. © 2000 Wiley‐Liss, Inc.