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

Primary Purpose

Focus of Study is Healthy Women at Risk for Breast Cancer

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

DUAVEE 0.45Mg-20Mg Tablet

About this trial

This is an interventional prevention trial for Focus of Study is Healthy Women at Risk for Breast Cancer focused on measuring Imaging, Biomarkers

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate active agent

Delayed active agent

Arm Description

Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)

No intervention for first 6 months. Then option to receive daily Duavee for 6 months.

Outcomes

Primary Outcome Measures

Number of potential participants who consent to enrollment

Trial design is acceptable to potential subjects, as evidenced by participation

Secondary Outcome Measures

Change in breast background parenchymal enhancement (BPE)

BPE assessed by abbreviated MRI at baseline and after 6 months

Change in fibroglandular volume (FGV)

FGV assessed by Volpara software on 3D mammograms acquired at baseline and after 6 months

Full Information

NCT ID

NCT04379024

First Posted

May 3, 2020

Last Updated

October 22, 2021

Sponsor

Carol Fabian, MD

Collaborators

Breast Cancer Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04379024

Brief Title

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

Official Title

Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Study agent no longer available

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

July 30, 2021 (Actual)

Study Completion Date

July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Carol Fabian, MD

Collaborators

Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.

Detailed Description

Duavee® which is the combination of the selective estrogen receptor modulator bazedoxifene and conjugated estrogen 0.45 mg) is an FDA approved drug for treatment of hot-flashes and prevention of osteoporosis in postmenopausal women. The investigators recently reported the results of a single arm pilot study suggesting that 6 months of Duavee® was associated with improvement in several risk biomarkers including benign breast tissue proliferation, mammographic fibroglandular volume, IGF-1, SHBG and progesterone in high risk women in late menopause transition. Prior to opening a randomized Phase IIB trial of 6 months of Duavee® vs placebo in high risk women with hot-flashes followed by open label Duavee®, the intent of this study is to assess probable uptake of such a trial design with a pilot of 6 months of Duavee® vs wait-list control in symptomatic women. Additional imaging biomarker information from MRI will be obtained. A finding on MRI of greater background parenchymal enhancement (BPE) in high risk women is positively associated with higher probability of developing breast cancer and is independent of fibroglandular volume. BPE is reduced by selective estrogen receptor modulators including tamoxifen. The investigators will investigate change in MRI BPE over time for women randomly assigned to either receive Duavee® or not (wait-list control). The investigators will also explore development of fully automated breast MRI volumetric density measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focus of Study is Healthy Women at Risk for Breast Cancer

Keywords

Imaging, Biomarkers

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Randomized to active agent or wait-list control.

Masking

None (Open Label)

Masking Description

Randomization assignment is masked to all roles prior to randomization. Subsequent to randomization, agent is dispensed open-label.

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate active agent

Arm Type

Experimental

Arm Description

Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)

Arm Title

Delayed active agent

Arm Type

Other

Arm Description

No intervention for first 6 months. Then option to receive daily Duavee for 6 months.

Intervention Type

Drug

Intervention Name(s)

DUAVEE 0.45Mg-20Mg Tablet

Other Intervention Name(s)

Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg

Intervention Description

One capsule daily for 6 months (+/- 1 month)

Primary Outcome Measure Information:

Title

Number of potential participants who consent to enrollment

Description

Trial design is acceptable to potential subjects, as evidenced by participation

Time Frame

Enrollment

Secondary Outcome Measure Information:

Title

Change in breast background parenchymal enhancement (BPE)

Description

BPE assessed by abbreviated MRI at baseline and after 6 months

Time Frame

6 months

Title

Change in fibroglandular volume (FGV)

Description

FGV assessed by Volpara software on 3D mammograms acquired at baseline and after 6 months

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol J Fabian, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7820

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31420361

Citation

Fabian CJ, Nye L, Powers KR, Nydegger JL, Kreutzjans AL, Phillips TA, Metheny T, Winblad O, Zalles CM, Hagan CR, Goodman ML, Gajewski BJ, Koestler DC, Chalise P, Kimler BF. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study. Cancer Prev Res (Phila). 2019 Oct;12(10):711-720. doi: 10.1158/1940-6207.CAPR-19-0315. Epub 2019 Aug 16.

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

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