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Hormone Therapy

Duavee for Breast Cancer

Phase 2
Recruiting
Led By Swati Kulkarni, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must have newly diagnosed histologically confirmed ER (+) DCIS scheduled to undergo surgical therapy
Ki-67, Cox-2, P-16, expression in immediately adjacent tissue is similar to what is found in DCIS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks
Awards & highlights

Study Summary

This trial is testing whether the study drug Duavee can help treat symptoms of menopause and reduce the risk of developing breast cancer in women with a condition called ductal carcinoma in situ (DCIS).

Who is the study for?
Postmenopausal women aged 18-79 with newly diagnosed ER (+) DCIS of the breast, scheduled for surgery. Participants must be able to swallow pills, sign consent forms, and have normal organ/marrow function. Excluded are those on certain drugs, with invasive breast cancer or other serious conditions like blood clots or active second cancers.Check my eligibility
What is being tested?
The PROMISE Study tests if Duavee (conjugated estrogens/bazedoxifene), approved for menopause symptoms but not for DCIS in postmenopausal women, affects breast tissue markers and is safe. It includes a placebo group and examines quality-of-life impacts through questionnaires.See study design
What are the potential side effects?
Potential side effects may include hot flashes relief-related issues since Duavee is used to treat menopause symptoms. However, as its use in DCIS is experimental, there could be unknown risks which this study aims to uncover.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman with a new ER+ DCIS diagnosis planning for surgery.
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My cancer's growth markers are similar to those in a specific breast condition.
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I have gone through menopause.
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I am confirmed to be postmenopausal after having a hysterectomy without removing both ovaries.
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I can take care of myself but might not be able to do heavy physical work.
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My DCIS is at least 1cm or found in multiple biopsy cores.
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I had surgery for cancer with some cancer cells still left at the edges.
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My blood counts and liver/kidney functions are within normal ranges.
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I can swallow pills.
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I am a woman aged between 18 and 79.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Ki-67 protein expression
Secondary outcome measures
Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire
Epithelial markers of progression
Expression of ERα
+6 more
Other outcome measures
Anterior Gradient 2 (AGR2)
Estrogen-modulated genes in the breast stroma
Expression of estrogen-modulated genes in breast epithelium
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (conjugated estrogens/bazedoxifene)Experimental Treatment5 Interventions
Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality-of-Life Assessment
2017
Completed Phase 3
~4950

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,071 Total Patients Enrolled
39 Trials studying Breast Cancer
12,475 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,507 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,714 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer

Media Library

Conjugated Estrogens/Bazedoxifene (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02694809 — Phase 2
Breast Cancer Research Study Groups: Arm II (placebo), Arm I (conjugated estrogens/bazedoxifene)
Breast Cancer Clinical Trial 2023: Conjugated Estrogens/Bazedoxifene Highlights & Side Effects. Trial Name: NCT02694809 — Phase 2
Conjugated Estrogens/Bazedoxifene (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02694809 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively seeking participants?

"Affirmative, according to information displayed on clinicaltrials.gov the trial is still searching for participants. This medical study was initially posted on January 1st 2017 and most recently modified on May 27th 2021. The requirement stands at 160 patients across 10 different sites."

Answered by AI

What risks, if any, are associated with the use of Conjugated Estrogens/Bazedoxifene?

"A score of 2 was assigned to Conjugated Estrogens/Bazedoxifene as phase two trials have established safety but not yet proven efficacy."

Answered by AI

What medical conditions are Conjugated Estrogens/Bazedoxifene commonly employed to combat?

"Premature menopause is commonly treated with Conjugated Estrogens/Bazedoxifene. This medication also helps treat issues such as female castration, vasomotor system instability, and other forms of menopausal distress."

Answered by AI

How many healthcare facilities are implementing this research trial?

"The medical trial is currently open to 10 sites, including Baltimore, Salt Lake City and Saint Louis. For the convenience of would-be participants, it's advisable to enroll at a location close by."

Answered by AI

Does this research endeavor include participation from elderly individuals?

"This trial is exclusively open to individuals aged between 18 and 79. Otherwise, 132 studies are available for patients younger than the age of consent while 4506 trials have been set up for those older than 65."

Answered by AI

Is there an opportunity for me to become a participant in this research?

"This clinical trial is seeking 160 participants with a breast cancer diagnosis, aged between 18 and 79."

Answered by AI

How many volunteers are participating in this clinical research endeavor?

"To facilitate this trial, 160 volunteers that meet the qualifications must be appointed. Pfizer will oversee its execution from various sites including John's Hopkins University in Baltimore and Huntsman Cancer Institute in Salt Lake City."

Answered by AI

Could you provide an overview of prior investigations regarding Conjugated Estrogens/Bazedoxifene?

"Since 2013, Conjugated Estrogens/Bazedoxifene has been tested in 19,074 trials with 15 currently active studies. The initial study took place at UTMB Speciality Care Center at Victory Lakes and many of the current research projects are located in Baltimore, Maryland."

Answered by AI
~19 spots leftby Apr 2025