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Increased Risk for Development of Breast CancerEarly Phase 1NCT04821375

Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers

A Early Phase 1 study testing bazedoxifene plus conjugated estrogens in people with Increased Risk for Development of Breast Cancer, run by Carol Fabian, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
bazedoxifene plus conjugated estrogens
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
2 Dec 2021to 31 Dec 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women who report vasomotor symptoms (hot flashes or night sweats or both).
  • No menstrual periods for at least 60 days.
  • Age 45-65. Women age 45-49 with prior hysterectomy or endometrial ablation with rare or no periods due to ablation must have a Follicle Stimulating Hormone (FSH) of 25 mIU/ml or higher to be eligible.
  • BMI <36 kg/m2
  • Risk Factors/Level. Moderate risk of developing breast cancer based on either by having any one or more of the following:
  • First or 2nd degree relative with breast cancer
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  • Known carrier of moderate to high penetrance germline mutation
  • Prior breast biopsy showing proliferative breast disease or multiple prior 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 (http://www.emstrials.org/riskevaluator/). 10-year relative risk of >2X that for the population for age group.
  • Prior mammogram must have at least a Volpara® fibroglandular volume of 80 cm3 or BIRADs b, c, or d category density and/or investigator estimated visual dense area of at least 25%. The entire breast must be incorporated in a single view for both the right and left breast. (i.e., women whose breasts are so large that the images must be captured as a mosaic are not eligible). If no prior mammogram, but breast density is readily appreciated and documented on physical exam, a study-provided 3D mammogram with Volpara® software must be performed to document above eligibility criterion. It will then constitute the baseline mammogram.
  • Willing to comply with study procedures:
  • Have blood drawn for screening tests - comprehensive metabolic panel (plus FSH if age 45-49 and no uterus or endometrial ablation)
  • Have blood drawn to archive serum for assay of estradiol, testosterone, progesterone, sex hormone binding globulin (SHBG), FSH at baseline and 6-month visits (and 12 months for women originally randomized to wait list control and subsequently taking BZA+CE for the next 6 months).
  • Undergo a history, physical, and breast exam at baseline and 6-month visits (and 12 months for women originally randomized to wait list control and subsequently taking BZA+CE for the next 6 months). History, physical exam and breast exam performed by a study-associated clinician within 3 months prior to enrollment may be substituted for baseline evaluations.
  • Have a mammogram at University of Kansas Medical Center (KUMC) with Volpara® volumetric density at baseline and 6-month visits (and 12 months for women originally randomized to wait list control and subsequently taking BZA+CE for the next 6 months).
  • Have a study provided abbreviated MRI at KUMC at baseline and 6-month visits.
  • Be contacted by the trial coordinator by phone, email, or text at months 1 and 3 (and months 7 and 9 for women originally randomized to wait list control and subsequently taking BZA+CE for the next 6 months).
  • Complete Mayo Clinic hot flash assessment at baseline and 6-month visits (and month 12 for women originally randomized to wait list control and subsequently taking BZA+CE for the next 6 months).
  • Women 45-55 with a functional uterus (e.g., no prior endometrial ablation), menstrual period in the past 12 months, and heterosexually active, must be agreeable to use some non-hormonal form of contraception while taking BZA+CE unless husband or partner has had a vasectomy.
  • Able to understand and sign an informed consent form for screening and for intervention.
  • Participants on the optional random periareolar fine needle aspiration (RPFNA) procedures must meet eligibility criteria for participation on HSC4601, Breast Random Fine Needle Aspiration and/or Nipple Aspirate Fluid Collection of Breast Tissue to Aid in Short-term Risk Assessment. Participants must sign a separate optional consent for this study as well as for HSC4601. However, any eligibility criteria dealing with hormone replacement therapy and SERMs are excluded to allow the 6-month aspiration.
  • Comprehensive Metabolic Panel shows clinically acceptable renal and hepatic function lab values.
  • For women with intact uterus and ovary(ies) and less than age 55, a negative pregnancy test is required.

Who cannot join

  • Risk: A prior biopsy showing pleomorphic lobular or ductal carcinoma in situ 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
  • Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for BZA+CE.
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  • Medications
  • Taking systemic hormones within two months (eight weeks) prior to baseline MRI and mammogram.
  • 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.
  • Mammogram with Volpara® software and/or abbreviated MRI interpreted as concerning for cancer - unless recommended breast biopsy has been performed and confirmed as benign.
  • Dispensing of BZA+CE for those randomized to receive it immediately does not occur within 3 months of baseline MRI.
  • Unwilling to comply with future study procedures.
  • Started hormone replacement, selective estrogen receptor modulator, or aromatase inhibitor after baseline studies performed but prior to randomization.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Pilot Study of Effects of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer

Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.

Read the detailed description

Duavee® which is the combination of the selective estrogen receptor modulator (SERM) bazedoxifene plus conjugated estrogens is an FDA approved drug for treatment of hot-flashes and prevention of osteoporosis in postmenopausal women. In a single arm pilot study 6 months of Duavee® was associated with improvement in several risk biomarkers including benign breast tissue proliferation, mammographic fibroglandular volume, and progesterone in women in late menopause transition and at high risk for development of breast cancer. Prior to opening a planned randomized Phase IIB trial of 6 months of Duavee® vs placebo in high risk women with hot-flashes followed by open label Duavee®, a pilot trial was initiated of 6 months of Duavee® vs wait-list control in symptomatic women (Study00145121; NCT04379024). This trial was also intended to provide additional imaging biomarker information from MRI which was not performed in the previous prior study. 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. Change in MRI BPE over time was also investigated for women randomly assigned to either receive Duavee® or not (wait-list control), as well as exploration of fully automated breast MRI volumetric density measures.

Unfortunately, midway through the trial, Duavee® became no longer available due to an issue with packaging and dissolution of the active agents. As an alternative, this current protocol will utilize separate agents of bazedoxifene (as Vivant® available from Japan) plus conjugated estrogens (available in the US as Premarin®). The specific objectives are identical to those in Study00145121, with the exception that Duavee® has been replaced by BZA+CE. The intent is to combine the results of both trials for analysis.

Being tested
bazedoxifene plus conjugated estrogens
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bazedoxifene plus conjugated estrogensDrug

    Also called BZA+CE

    6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.

Study groups in NCT04821375
Study groupRoleWhat they receive
Bazedoxifene plus conjugated estrogens immediatelyExperimentalImmediate receipt of 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.
Receives: Drug: bazedoxifene plus conjugated estrogens
Bazedoxifene plus conjugated estrogens wait listOtherAfter a 6-month waiting period, receipt of 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.
Receives: Drug: bazedoxifene plus conjugated estrogens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of potential participants who consent to enrollment

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

    Measured: Enrollment

Secondary outcomes (2)

  1. Change in breast background parenchymal enhancement (BPE)

    BPE assessed by abbreviated MRI at baseline and after 6 months

    Measured: 6 months

  2. Change in fibroglandular volume (FGV)

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start2 Dec 2021
  3. Primary completion20 May 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized at enrollment to either immediate study agent or study agent after a 6-months wait.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821375
Sponsor's protocol ID
Study00146761
Status last verified
Oct 2025
First submitted
18 Mar 2021
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31420361

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing bazedoxifene plus conjugated estrogens in people with Increased Risk for Development of Breast Cancer, run by Carol Fabian, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of potential participants who consent to enrollment (time frame: Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821375, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.

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