Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer (BabyTEARS)
Dana-Farber Cancer Institute
Summary
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)
Description
This randomized, double-blind, phase II trial is to evaluate the efficacy and safety of low-dose "baby" exemestane versus low-dose "baby" tamoxifen in post-menopausal women at high risk for breast cancer. Both medications are used at full doses for breast cancer treatment and to reduce breast cancer risk. Low dose tamoxifen has been shown to be effective at reducing risk with better tolerance. Participants will be randomized into one of two study groups: Group A: Exemestane versus Group B: Tamoxifen. Randomization means a participant is placed into a study group by chance. Neither a participa…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Any of the following criteria must be met: * 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…
Interventions
- DrugExemestane
A steroidal aromatase inhibitor, blinded capsules taken orally, per protocol.
- DrugTamoxifen
A selective estrogen receptor modulator, blinded capsules taken orally, per protocol.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts