Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation

NCT02729701

Last updated date
Study Location
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-61
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Duavee
Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Other Name: conjugated estrogens/bazedoxifene
Study Arms  ICMJE Experimental: Duavee
Participants will be asked to take Duavee for 6 months while on the study.
Intervention: Drug: Duavee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
40
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE up to 61 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729701
Other Study ID Numbers  ICMJE STUDY00002440
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Results will be published in aggregate; no individual participant data will be made available.
Responsible Party Carol Fabian, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Carol Fabian, MDUniversity of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP