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Denosumab to Prevent Breast Cancer in Women With BRCA1 Mutation (BRCA-P Trial)
BRCA-P Trial Summary
This trial is testing whether denosumab can prevent breast cancer in women with a BRCA1 gene mutation, which is linked to a higher risk of developing the disease.
BRCA-P Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRCA-P Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 37 Patients • NCT04026256BRCA-P Trial Design
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Who is running the clinical trial?
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- I have low calcium levels or a history of low calcium that's relevant to my health.I am fully active or restricted in physically strenuous activity but can do light work.I have a harmful BRCA1 gene mutation.I am currently taking medication for bone health or to stop new blood vessels from forming.I have had both breasts removed.I have a history or current issue with jaw bone disease or need oral surgery soon.I have had cancer before, but only skin, early-stage thyroid, or specific non-invasive types.I am not willing to use effective birth control during and for 5 months after my treatment.I have not used tamoxifen, raloxifene, or aromatase inhibitors for more than 3 years or in the last 3 months.I am not planning to have preventive breast surgery.Women who could become pregnant must have a negative pregnancy test when they join the study.I am between 25 and 55 years old.My recent tests show no signs of breast cancer.I currently show no signs of ovarian cancer.I have had ovarian, fallopian, or peritoneal cancer.I have previously used denosumab.I have a history of breast cancer.I am HIV positive.I am not using any experimental drugs, but I may be taking aspirin or NSAIDs.I have an active hepatitis B or C infection.
- 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.
- Group 1: Arm A (denosumab)
- Group 2: Arm B (placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
Can young adults participate in this research?
"The age criteria to participate in this study is being 25 years or older, and 55 years or younger."
Are you looking for participants for this clinical research right now?
"Yes, this is accurate. The website clinicaltrials.gov has information indicating that the study is still looking for participants. The trial was posted on February 23rd, 2022 and was updated most recently on August 1st, 2022."
Can you share some other instances where Denosumab has been used in research?
"Denosumab was first studied in 2014 at Hirslanden Klinik Aarau. So far, 18438 studies have completed. Right now, there are 49 trials recruiting patients, with a large portion of these based out of Englewood, Minnesota."
How many patients are being enrolled in this experiment?
"This study requires the recruitment of 300 individuals that satisfy the pre-determined inclusion criteria. Patients have the opportunity to participate at one of many locations, such as Mountain Blue Cancer Care Center - Swedish in Englewood, Minnesota or Mayo Clinic in Rochester in Rochester, Illinois."
How is Denosumab most often employed?
"Denosumab is the go-to medication for treating bone and bones. Additionally, it can be used to ameliorate skeletally mature, androgens, and malignant neoplasms."
Who meets the criteria to participate in this experiment?
"This clinical trial is testing a breast cancer treatment that is only effective for patients between the ages of 25 and 55. Out of the 300 patients that will be enrolled in the study, some will receive the experimental medication while others will not."
Are there any serious risks associated with Denosumab?
"There is some data supporting the efficacy of Denosumab, and it has been through multiple rounds of testing, so our team at Power rates its safety as a 3."
In how many different places can people participate in this research project?
"There are a total of 24 sites for this study, with 12 locations in the United States of America and 12 in other countries."
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