← Back to Search

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

Must not have

Prior bilateral mastectomy

History of ovarian cancer (including fallopian and peritoneal cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a harmful BRCA1 gene mutation.

Select...

I am between 25 and 55 years old.

Select...

I currently show no signs of ovarian cancer.

Select...

I am not planning to have preventive breast surgery.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had both breasts removed.

Select...

I have had ovarian, fallopian, or peritoneal cancer.

Select...

I have a history of breast cancer.

Select...

I have low calcium levels or a history of low calcium that's relevant to my health.

Select...

I have previously used denosumab.

Select...

I am currently taking medication for bone health or to stop new blood vessels from forming.

Select...

I have an active hepatitis B or C infection.

Select...

I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])

Secondary study objectives

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