Overview

Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms

Status:
Terminated
Trial end date:
2021-07-31
Target enrollment:
0
Participant gender:
Female
Summary
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Carol Fabian, MD
Collaborator:
Breast Cancer Research Foundation
Treatments:
Bazedoxifene
Estrogens
Estrogens, Conjugated (USP)
Criteria
Inclusion Criteria:

- Women who report vasomotor symptoms (hot flashes or night sweats)

- No menstrual periods for at least 3 months

- Must have at least one ovary (hysterectomy is permitted; bilateral salpingo-
oophorectomy is excluded).

- BMI <36 kg/m2

- Moderate risk of developing breast cancer based on having any one or more of the
following:

- First or 2nd degree relative with breast cancer

- Known carrier of moderate to high penetrance germline mutation

- Prior breast biopsy showing proliferative breast disease or multiple biopsies

- High mammographic density (Volpara® categories c or d or BIRADs density
assessment as heterogeneously or extremely dense (c or d).

- IBIS Breast Cancer Risk Evaluation Version 8 10-year relative risk of >2X that
for the population for age group.

Exclusion Criteria:

- Risk: A prior biopsy showing LCIS, DCIS, or invasive breast cancer.

- Medical Conditions:

- Have a predisposition to or prior history of thromboembolism, deep venous
thrombosis, pulmonary embolism, or stroke

- History of renal or liver disease

- Prior invasive ovarian or endometrial cancer

- Medications

- Current anticoagulant use other than low dose aspirin

- Taking systemic hormones within two months (eight weeks) prior to baseline MRI
and mammogram.

- Taking tamoxifen, raloxifene, Duavee, or any selective estrogen receptor
modulator, or an aromatase inhibitor within 12 months prior to baseline MRI and
mammogram.