A trial of atezolizumab and trastuzumab emtansine for breast cancer (ASTEFANIA)

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 that is more than 1cm across
• have cancer that has a large number of HER2 protein (HER2 positive)
• have a tissue sample (biopsy ) that shows whether your cancer has the PDL-1 protein 
• have had chemotherapy and HER2 treatment before surgery 
• have had surgery that has removed all your cancer  
• had your initial surgery within 3 months of going into a trial treatment group (randomisation )
• are fully active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
• 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 cancer that has spread to another part of the body
• have cancer that has started to grow again after completing treatment before surgery
• might be able to have radiotherapy but can’t due to another medical condition 
• have had another cancer in the past 5 years. This is apart from successfully treated in situ carcinoma of the cervix, non melanoma skin cancer , early (stage 1 ) womb cancer and DCIS
• have had too much of an anthracycline  chemotherapy drug such as doxorubicin. Your doctor will know if you have had one of these drugs and if you have had too much. 
• have already had atezolizumab or trastuzumab emtansine
• have had previous treatment with an immunotherapy  drug

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

• have moderate to severe nerve damage (peripheral neuropathy ) 
• are short of breath when resting or you need to use oxygen continuously 
• have a heart that isn’t working well enough. You will have tests to see if it is. Or you have any other heart problem  that could affect you taking part.
• have high blood pressure that isn’t controlled by medication
• have an autoimmune disease . This is apart from those where you are taking medication to replace a substance in your body. And some autoimmune diseases which your doctor will know about. 
• have lung problems such as scarring and inflammation
• have active tuberculosis (TB), HIV, hepatitis B or hepatitis C
• have active liver disease or other liver problems
• have major surgery within 4 weeks of randomisation. This is apart from your breast surgery. 
• have an anticipated need for surgery during the trial
• have a serious infection within 4 weeks of randomisation  
• have had an antibiotic  through a drip into a vein (intravenous)  within 2 weeks of randomisation. For antibiotics taken by the mouth (oral ) it is 5 days. Unless you are taking antibiotics to prevent an infection.
• have had a stem cell transplant  or an organ transplant
• have had treatment as part of another clinical trial  within 28 days of randomisation 
• have taken medication that stimulates the immune system  within 4 weeks of randomisation
• have had medication that damps down the immune system within 2 weeks of randomisation. Or you might need this type of medication during the trial. 
• have any other medical condition or mental health problem that your doctor or a member of the trial team thinks could affect you taking part

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

• are allergic or sensitive to the drugs used, any of their ingredients or how they are made. Your doctor will be able to tell you about this. 
• have a live vaccine  within 4 weeks of randomisation. Or you might need a live vaccine within 5 months of finishing treatment. 
• are pregnant or breastfeeding. Or you intend to become pregnant during treatment or within up to 7 months after finishing treatment.