A trial of giredestrant and Phesgo for breast cancer (heredERA)

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 adenocarcinoma  of the breast that has grown into surrounding tissues and you can’t have surgery to remove it or it has spread elsewhere in the body. 
• You have HER2  positive breast cancer.
• You have cancer that is oestrogen receptor positive (ER positive breast cancer ).
• You have at least one area of cancer that your doctor can measure on a scan.
• If you have had previous treatment for early breast cancer, the cancer came back more than 6 months after your last treatment that didn’t include a hormone treatment.
• You are active but might not be able to do heavy physical work (performance status 0 or 1).
• You have satisfactory blood test results.
• You are willing to use reliable contraception during the trial and for a period after if there is any chance that you or your partner could become pregnant. 
• You are at least 18 years old. 

As well as the above, to take part in the maintenance part of the trial the following must also apply.  

• You have had at least 4 cycles of induction treatment as part of this trial. This is Phesgo alongside either docetaxel or paclitaxel chemotherapy. 
• Your cancer didn’t get worse after induction treatment.
• The left side of your heart is working well. 

Who can’t take part

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

• have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
• have already had treatment for locally advanced or secondary breast cancer. This doesn’t include hormone treatment. You might be able to join if you had one hormone treatment for breast cancer that has spread or up to 2 cycles of Phesgo (or trastuzumab and pertuzumab) and docetaxel or paclitaxel.
• have already had treatment with fulvestrant or a similar drug 
• have already had treatment that targets HER2. You can join if you have had Phesgo, trastuzumab with pertuzumab, trastuzumab alone, ado trastuzumab emtansine, lapatinib, and neratinib before or after surgery. 
• have cancer that got worse within 6 months of having trastuzumab, with or without pertuzumab or ado-trastuzumab emtansine after surgery
• have side effects from past treatments unless they are mild. You can join if you have hair loss, pins or needles in your hands or feet (peripheral neuropathy) or other side effects that won’t affect you taking part.
• have had a lot of doses of the chemotherapy drugs called doxorubicin, liposomal doxorubicin, epirubicin or mitoxantrone in the past. Your doctor will know about this.
• have had radiotherapy to help with symptoms within 2 weeks of starting induction treatment 
• are taking an experimental drug as part of another clinical trial or took part in another trial within 28 days of starting induction treatment 
• have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer,  carcinoma in situ (CIS ), localised prostate cancer, ductal carcinoma in situ of the breast  or early stage womb cancer.

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

• are short of breath at rest due to your cancer or another health condition and need to have continuous oxygen 
• have had treatment with steroids for more than 3 months unless it was a low dose 
• have high blood pressure that isn’t well controlled 
• have a liver problem
• have a significant heart problem  or heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. 
• have an increased risk of bleeding, a condition that affects how your blood clots or a blood clot in a vein. This is unless the condition has been treated and is well controlled.  
• have had major surgery or a bad injury in the last 14 days 
• have HIV or another serious infection that needed treatment in the last 7 days. You can take part if you have HIV that is well controlled with medication. Your doctor will know this.
• are taking medication that affects the CYP enzymes within 2 weeks of starting trial treatment or it hasn't cleared your body 
• have had a serious COVID-19 infection within the last 14 days 
• have inflammatory bowel disease or any other problem with your bowel that isn’t well controlled
• are sensitive to a hormone treatment called luteinising hormone blockers . This applies only to men and women who haven’t been through the menopause .
• have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other 

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

• are allergic to any of the treatments in the trial or anything they contain
• are pregnant or breastfeeding