The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.
The names of the study drugs involved in this study are:
* Exemestane (a type of steroidal aromatase inhibitor) * Tamoxifen (a type of selective estrogen receptor modulator)
Postmenopausal state is defined⁸ as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.
Recent (within 12 months from date of consent form signature) histologic diagnosis of ER+ve (>5%) DCIS (patients with DCIS should have undergone breast-conserving therapy i.e. lumpectomy to remove the tumor with negative surgical margins followed by radiotherapy (see footnote 1 below)) diagnosis within 3 years of HRL (ADH, LCIS, ALH), or;
At least 3% breast cancer risk at 5 years (or 5% risk at 10yrs) per one of the following risk models: the Breast Cancer Surveillance Consortium risk calculator V3 or Tyrer-Cuzick model V8 or;
Known carriers of a germline pathogenic/likely pathogenetic variant in the following moderate penetrance genes (CHEK2 or ATM), or women with chest wall irradiation before age of 30 years
Pre/perimenopausal women: exemestane is only effective in post-menopausal women
History of DVT or PE: tamoxifen can increase tendency to blood clot
Endometrial cancer: full-dose tamoxifen is associated with increased risk of endometrial cancers
Macular disorders: tamoxifen is associated with retinal damage
Parallel
Exemestane
DrugA steroidal aromatase inhibitor, blinded capsules taken orally, per protocol.
Tamoxifen
DrugA selective estrogen receptor modulator, blinded capsules taken orally, per protocol.
Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months
The MENQOL assesses the degree to which menopausal symptoms are troublesome in four domains: vasomotor (three items), sexual (three items), physical (seven items), and psychosocial (16 items). Each item is answered with Yes or No. If the response is Yes, the participant rates how bothersome the symptom was on a scale from 0 to 6, where 0 indicates "not at all bothered" and 6 indicates "extremely bothered." For each participant, the difference between the baseline and 12-month overall MENQOL score will be calculated and defined as the "change."
Difference of Free Estradiol Levels between Two Arms at 12 Months
Free estradiol concentration in blood will be measured to compare the hormonal effects of babyexe versus babytam.
Difference of Estradiol/Sex Hormone Binding Globulin (SHBG) Levels between Two Arms at 12 Months
The estradiol/SHBG ratio will be calculated as total estradiol divided by SHBG to evaluate differences in hormonal effects between babyexe and babytam.
Difference of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Levels Between Two Arms at 12 Months
Blood levels of IGF-I will be measured to compare the effects of babyexe and babytam on IGF-I.
Insulin-like Growth Factor I (IGF-I)/Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Ratio Between Two Arms at 12 Months
The ratio of IGF-I to IGFBP-3 in blood will be calculated to compare the effects of babyexe and babytam on IGF system balance.
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Dana-Farber Cancer Institute
Lead sponsor
Breast Cancer Research Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
