A trial looking at camizestrant for early breast cancer (CAMBRIA-2)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:

• have invasive breast cancer. The cancer may have spread into nearby lymph nodes , the chest wall or the skin but no further. Your doctor checks this to see if you are suitable to take part. 
• have had surgery to treat your breast cancer. You may or may not have also had chemotherapy or radiotherapy . 
• have cancer that has a medium to high risk of coming back after surgery
• have cancer that is oestrogen receptor positive and HER2 negative
• join a treatment group within a year of having surgery
• are put into a treatment group within 3 months of radiotherapy or the last dose of chemotherapy if you had this.
• completed radiotherapy if you had this at least 2 weeks before being put into a treatment group. This applies only to people having a drug called abemaciclib.
• have a sample of tissue (biopsy ) from a previous sample that the team can use to do some tests on
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1) 
• are willing to use reliable contraception during the trial and for a time after if there is any chance you or your partner could become pregnant 
• have satisfactory blood test results 
• are at least 18 years old 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have breast cancer that can’t be removed with surgery, has spread to the lymph nodes in the opposite breast or has spread to distant parts of the body 
• have inflammatory breast cancer 
• have had more than 12 weeks of hormone treatment. This could be before or after surgery. Or you had more than 12 weeks of abemaciclib.
• have cancer that went away completely after chemotherapy if you had this before surgery
• have already had camizestrant or a similar drug, you have had an experimental treatment for ER positive breast cancer or you have had fulvestrant 
• are having another cancer treatment. You can take part if you are having treatment to strengthen the bones such as bisphosphonates or denosumab. 
• have had another breast cancer in the past. You might be able to take part if you had ductal carcinoma in situ (DCIS) . The team checks which breast you had the cancer in, what treatments you had and how long ago you had them. 
• have had another cancer that has got worse or needed treatment in the past 5 years. This is apart from successfully treated non melanoma skin cancer , carcinoma in situ (CIS) of the cervix or another cancer that has a low chance of coming back.
• are taking part or have taken part in another clinical trial. You might be able to join if it didn’t involve an experimental drug or device. This is an observation trial. 

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

• have a significant heart problem or a heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. 
• have had a stroke or mini stroke in the last 6 months 
• have a slow heartbeat at rest
• have low blood pressure or high blood pressure that isn’t well controlled with medication
• can’t absorb tablets for any reason. This could be because you have had part of your bowel removed. 
• can’t swallow the trial medication 
• have had major surgery or a significant traumatic injury within 2 weeks of being put into a treatment group
• have hormone treatment for birth control or hormone replacement therapy (HRT ) that you don’t apply to the skin 
• take medication that affects substances in the body called CYP enzymes within 2 weeks of starting trial treatment. Your doctor can tell you more about this.
• have any medical condition or mental health problem that could affect you taking part

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

• were put into a treatment group for this trial previously but you had to withdraw from the trial for some reason. You can’t rejoin this trial. 
• are allergic to camizestrant, similar drugs or anything they contain 
• are allergic to luteinising hormone blockers or anything they contain. This only applies to women who haven’t been through menopause or men. 
• are pregnant or breastfeeding