Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Sacha Howell
+44 (0)161 291 4408
Sacha.howell@nhs.net


Ms Karen Rhodes
+44 (0)161 291 4962
karen.rhodes@mft.nhs.uk


Dr Gareth Evans
+44 (0)161 291 4408
gareth.evans@mft.nhs.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germline mutation
Back

Study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germline mutation

Recruiting

Open to: Female

Age: Mixed

Manchester

Medical Conditions

Breast cancer

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.



Background and study aims
This is a preventional later-stage clinical trial in patients with breast cancer. The primary aim is to establish if there is a reduction in the risk of any invasive or ductal carcinoma in situ (occurring inside a milk duct of the breast) breast cancer in women with a germline BRCA1 mutation, a harmful gene variant that can be inherited from either parent when they are treated with the cancer drug denosumab compared to a dummy control drug (placebo).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Nov 2022 31 Dec 2024

The study duration is projected to be a total of 12 years, comprising a 2-year enrolment phase, a 5-year treatment phase and a 5-year follow-up phase. The target recruitment is 2918 participants. Once consented, participants will be randomised in a 1:1 ratio using an interactive voice and/or web-based response system. Arm A will be treated with: Denosumab 120 mg by injection under the skin, every 6 months for a duration of 5 years. Arm B will be treated with the placebo comparator with the same routine.

Participation in the study will involve a screening/consent visit followed by treatment visits every 6 months for a duration of 5 years. Participants will then be followed up every 12 months for 5 years after the point that the last investigation product is administered.


Women aged between 25 and 55 years old with a confirmed BRCA 1 germline deletion or likely deletion mutation

You can take part if:



You may not be able to take part if:


1. Prior bilateral mastectomy2. History of ovarian cancer (including fallopian tube and primary peritoneal cancer)3. History of breast cancer4. History of invasive cancer except for basal cell or squamous cell skin cancer. History of the following are also allowed: carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (Lobular Carcinoma In Situ)5. Pregnant or lactating women (within the last 2 months prior to randomization)6. Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential. Clinically relevant hypocalcaemia (history and current condition), or serum calcium <2.0 mmol/L (<8.0 mg/dL) Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be ‘corrected’ before dosing the participant). Monitoring of calcium level in regular intervals (usually prior to IP administration) is highly recommended7. Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior HRT is permitted)8. Prior use of denosumab9. Participant has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction within 3 months of enrollment10. Concurrent treatment with a bisphosphonate or an anti-angiogenic agent11. Any major medical or psychiatric condition that may prevent the participant from completing the study12. Hepatic impairment (defined as known chronic liver disease such as alcoholic cirrhosis or chronic autoimmune hepatitis or transaminases (aspartate aminotransferase or alanine aminotransferase) >1.5x upper limit of the laboratory normal range.13. Known active infection with Hepatitis B virus or Hepatitis C virus14. Known infection with human immunodeficiency virus (HIV)Use of any other investigational product (current or prior Aspirin or NSAIDs are permitted) 15. Hypersensitivity to the active substance or to any of the excipients16. Known rare hereditary problems of fructose intolerance


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester University Hospital NHS Ft (hq)
    Oxford Road
    Manchester
    M13 9WL

The blood tests could cause pain and bruising. Only nurses experienced in phlebotomy will take blood samples in this study.
Denosumab may cause side effects which are listed in the PIS as follows:
Very Common side effects (which may affect more than 1 person in 10):
1. Low blood calcium
2. Shortness of breath
3. Muscle and bone pain
Common side effects (which may affect between 1 and 10 people in every 100):
1. Decreased phosphorus in the blood
2. Osteonecrosis of the jaw
3. Hair loss (alopecia)
Uncommon effects (which may affect between 1 and 10 people in every 1,000):
1. High blood calcium in patients with Giant Cell Tumor of Bone (GCTB) after stopping denosumab
2. Unusual thigh bone fracture (atypical femoral fracture
3. Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption)
Rare side effects (which may affect between 1 and 10 people in every 10,000):
1. Allergic reaction (drug hypersensitivity)
2. Broken bones in your spine after stopping Denosumab

Ms Karen Rhodes
+44 (0)161 291 4962
karen.rhodes@mft.nhs.uk


Dr Sacha Howell
+44 (0)161 291 4408
Sacha.howell@nhs.net


Dr Gareth Evans
+44 (0)161 291 4408
gareth.evans@mft.nhs.uk



The study is sponsored by Manchester University NHS Foundation Trust and funded by Austrian Breast and Colorectal Cancer Study Group (ABCSG); Amgen; U.S. Department of Defense.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN77394655

Or CPMS 54435

Last updated 20 November 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top