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Monoclonal Antibodies

Denosumab to Prevent Breast Cancer in Women With BRCA1 Mutation (BRCA-P Trial)

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)
Age >= 25 years and =< 55 years at randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Pivotal 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.

Who is the study for?
Women aged 25-55 with a BRCA1 gene mutation, no breast or ovarian cancer, and not planning preventive breast surgery can join. They must have normal recent breast exams, not be pregnant or breastfeeding, agree to use contraception, and have good physical health.Check my eligibility
What is being tested?
The trial is testing if Denosumab can prevent breast cancer in women with the BRCA1 mutation compared to a placebo. It's a phase III study where participants are randomly given either Denosumab or an inactive substance while their quality of life is monitored.See study design
What are the potential side effects?
Denosumab may cause issues like jaw bone problems (osteonecrosis), low calcium levels in the blood (hypocalcemia), infection risks, and possibly interfere with healing after dental procedures.

BRCA-P Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a harmful BRCA1 gene mutation.
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I am between 25 and 55 years old.
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My recent tests show no signs of breast cancer.
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I currently show no signs of ovarian cancer.
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I am not planning to have preventive breast surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.

BRCA-P Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])
Secondary outcome measures
Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Frequency of benign breast lesions
Frequency of breast biopsies
+5 more

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
31%
nausea
15%
headache
15%
rhinorrhea
8%
phototoxic dermatitis
8%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriparatide Only
Denosumab and Teriparatide
Denosumab Only

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

BRCA-P Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (denosumab)Experimental Treatment2 Interventions
Patients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (placebo)Placebo Group2 Interventions
Patients receive placebo SC q6m for up to 5 years in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2017
Completed Phase 4
~12500

Find a Location

Who is running the clinical trial?

Austrian Breast & Colorectal Cancer Study Group (ABCSG)UNKNOWN
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,334 Total Patients Enrolled
74 Trials studying Breast Cancer
39,843 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,579 Previous Clinical Trials
41,224,179 Total Patients Enrolled
937 Trials studying Breast Cancer
1,542,036 Patients Enrolled for Breast Cancer

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04711109 — Phase 3
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711109 — Phase 3
Breast Cancer Research Study Groups: Arm A (denosumab), Arm B (placebo)
Breast Cancer Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT04711109 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~187 spots leftby Jul 2027