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Duavee for Breast Cancer
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).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had allergic reactions to similar medicines as CE/BZA.I am a woman with a new ER+ DCIS diagnosis planning for surgery.You cannot take any other experimental medications. If you were taking one before, you need to stop for at least 4 weeks before you can join the study.I have another active cancer besides non-melanoma skin cancer.I have a history of blood clots or bleeding disorders.I am not taking any strong medication that affects liver enzymes.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.The size of the DCIS on the imaging meets the standards set by the hospital.My cancer's growth markers are similar to those in a specific breast condition.I have gone through menopause.I am confirmed to be postmenopausal after having a hysterectomy without removing both ovaries.I can take care of myself but might not be able to do heavy physical work.I am currently using hormone replacement therapy or related medications.My breast cancer has come back on the same side.I am not pregnant or breastfeeding.My DCIS is at least 1cm or found in multiple biopsy cores.I had surgery for cancer with some cancer cells still left at the edges.My blood counts and liver/kidney functions are within normal ranges.I can swallow pills.I have been diagnosed with invasive breast cancer.I am a woman aged between 18 and 79.
- Group 1: Arm II (placebo)
- Group 2: Arm I (conjugated estrogens/bazedoxifene)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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