
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is looking at adding giredestrant to Phesgo to improve treatment for breast cancer.
It is for people whose cancer has grown into surrounding tissues or has spread to other parts of the body. Also, the cancer:
Breast cancer that has grown into surrounding tissues is . Breast cancer that has spread to another part of the body is secondary breast cancer. Doctors are looking for ways to improve treatment for these groups of people.
Giredestrant is a new type of hormone treatment. It blocks the hormone oestrogen.
Pertuzumab and trastuzumab are usual treatments for breast cancer that has tested positive for HER2. The combination of trastuzumab and pertuzumab as an injection under the skin is called Phesgo. It works by targeting and blocking the HER2 protein on the breast cancer cell. This stops signals that cancer cells use to divide and grow.
This trial is in 2 parts. The first part is called the induction phase. You will have Phesgo and one of the following chemotherapy drugs:
After the induction phase, you might be able to have long term (maintenance treatment) with one of the following:
The main aims of the trial are to find out:
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.
As well as the above, to take part in the maintenance part of the trial the following must also apply.
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This phase 3 trial is taking place worldwide. The team need to find 821 people to take part including 40 from the UK.
This trial is in 2 parts:
Induction phase
Everyone has one of the following treatments:
Your doctor can tell you which treatment you will have.
You have that last 3 weeks. You have about 4 to 6 cycles. This takes between 3 and 4 ½ months.
You have Phesgo as an injection into the thigh just under the skin. You have docetaxel or paclitaxel as a drip into a vein.
You have Phesgo once every 3 weeks and:
Treatment takes about 1 to 3 hours each time. You might be at hospital for longer than this.
You can join the maintenance part of the trial if your cancer doesn’t get worse.
Maintenance treatment
This part of the trial is randomised. There are 2 groups. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
You have Phesgo as described above.
Giredestrant is a capsule. You take one capsule, once a day, every day. You fill in a diary to record when you take the capsules.
The doctor will talk to you about hormone treatment if they think you need it. This applies only to people having Phesgo on its own.
Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They will also ask to look at:
The researchers plan to use the samples to:
They might ask to use any leftover samples for future research. You can say no to this if you don’t want your samples to be used.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
You have treatment at the hospital on the day care ward. You see the doctor every 3 weeks for a check up and blood tests.
Trial scans
You have a bone scan and a CT scan or MRI scan at:
Follow up
You see the doctor a month after you finish treatment. After that, you see them every 3 months for a check up. Or they might call you at home to see how you are. The follow up is every 6 months if you stopped treatment after induction treatment.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Giredestrant is a new drug. So there may be side effects we don’t know about yet. The most common side effects we know about so far include:
We have information about the following treatments and their side effects:
Your doctor will talk to you about the possible side effects of the treatments before you agree to take part. You’ll have a chance to ask any questions you may have.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Catherine Harper-Wynne
Roche
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”