Focus of Study is Healthy Women at Risk for Breast CancerEarly Phase 1NCT04379024
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms
A Early Phase 1 study testing DUAVEE 0.45Mg-20Mg Tablet in people with Focus of Study is Healthy Women at Risk for Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
Trial summary
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is Healthy Women at Risk for Breast Cancer
- What is being tested?
- DUAVEE 0.45Mg-20Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Jul 2021
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160-7820
About this study
Official title: Pilot Study of Effects of Duavee® 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 Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.
Read the 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.
- Being tested
- DUAVEE 0.45Mg-20Mg Tablet
- Keywords
- Imaging, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUAVEE 0.45Mg-20Mg TabletDrug
Also called Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg
One capsule daily for 6 months (+/- 1 month)
| Study group | Role | What they receive |
|---|---|---|
| Immediate active agent | Experimental | Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg) Receives: Drug: DUAVEE 0.45Mg-20Mg Tablet |
| Delayed active agent | Other | No intervention for first 6 months. Then option to receive daily Duavee for 6 months. Receives: Drug: DUAVEE 0.45Mg-20Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of potential participants who consent to enrollment
Trial design is acceptable to potential subjects, as evidenced by participation
Measured: Enrollment
Secondary outcomes (2)
Change in breast background parenchymal enhancement (BPE)
BPE assessed by abbreviated MRI at baseline and after 6 months
Measured: 6 months
Change in fibroglandular volume (FGV)
FGV assessed by Volpara software on 3D mammograms acquired at baseline and after 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.
- First posted7 May 2020
- Study start1 Jun 2020
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
Why it stopped: Study agent no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus of Study is Healthy Women at Risk for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 to active agent or wait-list control.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379024
- Sponsor's protocol ID
- Study00145121
- Status last verified
- Mar 2021
- First submitted
- 3 May 2020
- Last updated
- 29 Oct 2021
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT04379024
- Acronym / sponsor ID
- Study00145121
- Keywords
- Imaging, Biomarkers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study agent no longer available
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to active agent or wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Immediate active agent | Experimental | Drug: DUAVEE 0.45Mg-20Mg TabletDuavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg) |
| Delayed active agent | Other | Drug: DUAVEE 0.45Mg-20Mg TabletNo intervention for first 6 months. Then option to receive daily Duavee for 6 months. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (9 listed)
- Risk: A prior biopsy showing LCIS, DCIS, or invasive breast cancer.
- Medical Conditions:
- Medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DUAVEE 0.45Mg-20Mg TabletAlso: Bazedoxifene 20 mg plus conjugated estrogens 0.45 mgOne capsule daily for 6 months (+/- 1 month) | Drug | Delayed active agent, Immediate active agent |
Primary outcome
Number of potential participants who consent to enrollment
Time frame: Enrollment
Trial design is acceptable to potential subjects, as evidenced by participation
2 secondary outcomes
Change in breast background parenchymal enhancement (BPE)
Time frame: 6 months
Change in fibroglandular volume (FGV)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study agent no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 31420361Fabian 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol J Fabian, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DUAVEE 0.45Mg-20Mg Tablet in people with Focus of Study is Healthy Women at Risk for 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Oct 2021. 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 was stopped early (reason given: Study agent no longer available). Results are not available in the source record.
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 NCT04379024, 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 2021.