Study on Denosumab to Prevent Breast Cancer in Women with BRCA1 Mutation

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What is this study about?

This clinical trial is focused on the prevention of breast cancer in women who carry a specific genetic change known as the BRCA1 germline mutation. The study is investigating whether a medication called Denosumab, which is given as a solution for injection, can help prevent the development of breast cancer in these women. Denosumab is a type of protein-based medication that is already used for other medical conditions.

The purpose of the study is to see if Denosumab can reduce the risk of developing any type of breast cancer, including invasive breast cancer or a condition called DCIS (ductal carcinoma in situ), which is an early form of breast cancer. Participants in the study will receive either Denosumab or a placebo, and the study will compare the outcomes between these two groups. The study will also look at other health outcomes, such as the time it takes for any breast cancer to develop, the occurrence of other types of cancer, and the frequency of breast biopsies.

The study will take place over several years, with participants receiving regular injections and undergoing health assessments to monitor for any signs of breast cancer or other health changes. The goal is to gather information that could lead to new ways to prevent breast cancer in women with the BRCA1 mutation.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, denosumab, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

You will be informed about the study procedures and asked to provide written consent to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes confirming your BRCA1 germline mutation status and ensuring there is no evidence of breast cancer through MRI or mammogram and clinical breast examination.

A negative pregnancy test is required if you are of childbearing potential.

3 medication administration

If you are assigned to the denosumab group, you will receive XGEVA 120 mg as a solution for injection. This will be administered subcutaneously, which means it is injected under the skin.

The injections will be given at regular intervals as specified by the study protocol.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your health and any potential side effects. These visits will include physical examinations and possibly additional imaging tests.

The frequency and duration of these visits will be determined by the study protocol.

5 end of study participation

Your participation in the study will continue until the estimated end date of July 1, 2030, unless you choose to withdraw earlier or if the study is terminated for any reason.

At the end of the study, a final assessment will be conducted to evaluate your health and the outcomes of the study.

Who Can Join the Study?

Women with a confirmed harmful or likely harmful change in the BRCA1 gene (known as Variant class 4 or 5).
Age between 25 and 55 years at the time of joining the study.
No signs of breast cancer as shown by MRI (Magnetic Resonance Imaging) or MG (Mammogram) and a clinical breast exam within the last 6 months before joining the study.
No signs of ovarian cancer at the time of joining the study.
A negative pregnancy test at the time of joining the study for women who can have children.
No plans for preventive breast surgery at the time of joining the study.
An ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but does not need bed rest during the day.
Must provide written informed consent before any study-specific procedure is done, meaning they agree to participate after understanding the study details.

Who Cannot Join the Study?

Women who do not have a BRCA1 germline mutation cannot participate. This is a specific change in a gene that can increase the risk of breast cancer.
Men are not eligible to participate in this study.
Participants must be within a certain age range, which is not specified here.
Individuals who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Hospital San Pedro De Alcantara	Caceres	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Uxujbvmsow Mgssuei Cjjyir Hhejaupnjypqxnupt	Hamburg	Germany
Orhtjqdxigrevu Lsuk Gqvj	Linz	Austria
Irhclwsv Codask Diitrherzzzkehpih	L'hospitalet De Llobregat	Spain
Uaelyfvfqj Hclenszz Cdmovrz	Cologne	Germany
Kzoskygj dic Uzxfpjlvajww Mriivqqe Aoe	Munich	Germany
Hwwwxldv Du Li Spqpz Cezu I Slmn Pla	Barcelona	Spain
Hzatlczi Vlbn djpxtzxq	Barcelona	Spain
Higvhedr Uxcebqebfpzus da A Csasmw	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.05.2019
Germany	Recruiting	01.05.2019
Spain	Recruiting	01.05.2019

Trial locations

Investigated drugs:

Denosumab

Denosumab is a medication used in this clinical trial to help prevent breast cancer in women who have a specific genetic mutation known as BRCA1. This mutation increases the risk of developing breast cancer. Denosumab works by targeting and blocking a protein in the body that is involved in the growth of cancer cells. By doing this, it may help reduce the risk of breast cancer developing in these women. The trial is designed to see how effective denosumab is in preventing breast cancer compared to not using the medication.

Investigated diseases:

Breast cancer

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, most commonly in the ducts or lobules. The disease progresses as these abnormal cells invade nearby tissues and can spread to other parts of the body. Invasive breast cancer means the cancer cells have spread beyond the original site. Ductal carcinoma in situ (DCIS) is a non-invasive form where cells are confined to the ducts. Over time, DCIS can become invasive if not managed.

Trial ID:

2024-513734-38-00

Protocol code:

BRCA-P/ABCSG 50

NCT ID:

NCT04711109

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Denosumab to Prevent Breast Cancer in Women with BRCA1 Mutation

What is this study about?

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