Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 61 |
| Updated: | 2/8/2019 |
| Start Date: | April 2016 |
| End Date: | June 2019 |
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation in Peri or Post-menopausal Women at Moderate Risk for Development of Breast Cancer
The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated
by peri- and post-menopausal women at moderate risk for development of breast cancer.
by peri- and post-menopausal women at moderate risk for development of breast cancer.
Duavee® is tissue specific estrogen complex of bazedoxifene plus conjugated estrogen which is
FDA approved for relief of menopausal symptoms and prevention of osteoporosis in women with a
uterus who have not been diagnosed with estrogen dependent neoplasia. The overall purpose of
this research is to demonstrate in a preliminary fashion that despite reduction in menopausal
symptoms, (Duavee®) does not increase and may decrease proliferation in benign breast tissue
in a cohort of peri- or post-menopausal women at moderately increased risk for breast cancer.
If this pilot shows rapid accrual, good retention, and lack of significant increase in the
risk biomarker Ki-67 in benign breast tissue, a larger prevention trial is envisioned
FDA approved for relief of menopausal symptoms and prevention of osteoporosis in women with a
uterus who have not been diagnosed with estrogen dependent neoplasia. The overall purpose of
this research is to demonstrate in a preliminary fashion that despite reduction in menopausal
symptoms, (Duavee®) does not increase and may decrease proliferation in benign breast tissue
in a cohort of peri- or post-menopausal women at moderately increased risk for breast cancer.
If this pilot shows rapid accrual, good retention, and lack of significant increase in the
risk biomarker Ki-67 in benign breast tissue, a larger prevention trial is envisioned
Inclusion Criteria:
- Women with vasomotor symptoms with a uterus who are postmenopausal or in late
menopause transition
- Body Mass Index (BMI) <36 kg/m2
- Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration
(RPFNA); If Class 0 or 4, must be resolved with additional procedures
- If previously on oral contraceptives or hormone replacement, off for 8 weeks or more
prior to baseline RPFNA; the exception is low dose vaginal hormones
- Confirmed moderate risk of developing breast cancer
- RPFNA results within study defined range
- Kidney and liver function within study defined range
- Willing and able to comply with study related procedures
Exclusion Criteria:
- Previous biopsy showing evidence of breast cancer
- Have a predisposition to or prior history of thromboembolism, deep venous thrombosis,
pulmonary embolism, or stroke
- History of renal or liver disease
- Prior ovarian or endometrial cancer
- Stopped or started hormone replacement within 8 weeks
- Any other condition or intercurrent illness that in the opinion of the investigator
makes the woman a poor candidate for RPFNA
- Currently taking or have taken specific medications in the past 6 months
- Participation on any chemoprevention trial within 6 months
- Current illness which would make potential participant unsuitable for enrollment
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