A study of durvalumab with other cancer drugs for triple negative breast cancer (BEGONIA)

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if all of the following apply. You are a woman and:

• have triple negative breast cancer (TNBC) that has spread to another part of the body
• have not had treatment for your cancer spread. If you had TNBC that was treated with the aim to cure and then it had spread, you must have completed your initial treatment such as surgery or chemotherapy at least 6 months ago. If you had a chemotherapy drug called a taxane  such as paclitaxel it must have been finished at least a year ago.
• are generally well and active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• must weigh at least 35kg
• have at least 1 area of cancer that hasn’t had radiotherapy treatment and that the doctor can measure on a scan
• are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
• are at least 18 years old

Who can’t take part
You cannot join this study if any of these apply. 

Cancer related
You:

• have cancer that has spread to your brain or spinal cord. Unless it has been treated and you have had 2 scans (4 weeks apart) that show it is stable. You have no symptoms and aren’t taking steroids. Or have been taking 10mg or less for at least 2 weeks before taking part in the study.
• have cancer that has spread to the layer of tissue (meninges) that surrounds the brain 
• have ongoing moderate to severe side effects from previous cancer treatment. This is apart from hair loss and vitiligo. You might be able to take part if you have ongoing nerve damage (neuropathy), or side effects that may not be made worse by the study drug, talk to your doctor or the study team about this. 
• are taking other cancer drugs apart from bisphosphonates  and denosumab to treat cancer spread in the bone
• have already had an immunotherapy  cancer drug
• have had radiotherapy unless it was at least 1 year ago. For radiotherapy to the brain or to control bone pain (where less than 30% of your bone marrow  was affected) it is at least 4 weeks before starting the study treatment.
• have had cancer growth blocker drugs 
• have had an antibody drug conjugate such as trastuzumab deruxtecan that works in the same way as datopotamab deruxtecan. Your doctor will know about this.
• have had another cancer apart from successfully treated non melanoma skin cancer , lentigo maligna (a type of early melanoma skin cancer) or carcinoma in situ . Or any other cancer that has been treated with the aim to cure and there has been no sign of it for 5 years or more.
• have spinal cord compression. Unless it has been treated, it is stable and you have no symptoms and aren’t taking steroids or you are taking medication to control seizures (fits).

Medical conditions
You cannot join this study if any of these apply. You: 

• have had an organ transplant
• have an eye problem or disease that affects the outer covering of the eye (cornea). Your doctor will know about this.
• have an autoimmune disease , such as rheumatoid arthritis or systemic lupus erythematous, apart from vitiligo, hair loss or an ongoing skin condition that doesn’t need treatment that affects the whole body. You might be able to take part if you are taking thyroid  hormone tablets to replace low levels of these hormones after treatment for a condition such as Hashimoto syndrome or if there has been no sign of your autoimmune disease for at least 5 years.
• have an inflammatory disease such as an inflammatory bowel disease. You might be able to take part if there has been no sign of it for the past 5 years.
• have an ongoing or active infection
• have had a heart attack, heart surgery, chest pain (angina) or congestive heart failure in the past 6 months or you have ongoing heart problems such as uncontrolled angina or an irregular heartbeat (heart rhythm)  
• are at risk of developing heart problems
• have an ongoing problem with your immune system  or it isn’t working well enough
• are taking medication, such as steroids, that affect how well your immune system works within 2 weeks of starting treatment apart from inhalers, creams, local injections (such as into the joints) or a dose of 10mg or less of steroid tablets 
• have tuberculosis (TB), hepatitis B, hepatitis C or HIV
• have diabetes type 1 or have abnormal blood sugar  levels 
• have had a blood clot in the past 6 months
• have major surgery within 28 days of starting treatment apart from surgery to a small area (local) to relieve symptoms of bone pain 
• are taking vitamin E supplements, or multivitamins that contain vitamin E, that give more than 100% of the recommended daily dose of vitamin E
• are taking medication that affects the CYP enzymes within 2 weeks of starting treatment (3 weeks for St John’s Wort)
• have taken part in a clinical trial using an experimental drug within the past 28 days 
• are taking part in a clinical trial unless it is an observational study only or you are being followed up after having treatment or using a device as part of a clinical trial

Other
You cannot join this study if any of these apply. You: 

• have a live vaccine  within 30 days of starting treatment. The COVID-19 vaccines are not considered to be live vaccines.  
• are allergic to the drugs, or any of their ingredients, used in this study 
• are pregnant or breastfeeding

Genetic sample research 
You cannot take part in the genetic research part of the study if either of the following apply. You:

• have had a donor bone marrow transplant (allogeneic transplant )
• or you have had a whole blood transfusion where the white blood cells  haven’t been taken out within 120 days of the team taking the sample