
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing giredestrant and palbociclib with letrozole and palbociclib for breast cancer.
It is open to people with breast cancer that has many oestrogen receptors (). The people taking part also have cancer that had spread into the surrounding tissue or to another part of the body.
Women and men have the hormone in their body. And oestrogen can make some breast cancers grow. These are oestrogen positive breast cancers (ER positive breast cancer). Treatment for these cancers are either to block the hormone getting to the cancer cells. Or to lower the amount of the hormone in the body. This is hormone therapy.
Giredestrant is a new hormone therapy drug. It blocks oestrogen getting to the breast cancer cells.
Letrozole is a hormone therapy for women who have gone through the . It works by lowering the level of oestrogen in the body.
Palbociclib is a targeted drug called a cancer growth blocker. It works by blocking proteins that cancer cells use to grow and divide. Doctors use palbociclib for breast cancer that has spread to the surrounding tissue or to another part of the body.
Researchers think that adding giredestrant to palbociclib might work well for people with ER positive breast cancer that has spread. In this trial there are 2 treatment groups:
The aims of this trial are to compare giredestrant and palbociclib with letrozole and palbociclib 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. You:
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 is an international phase 3 trial. The trial team need 978 people worldwide with 40 people from the UK to join.
It is a randomised double blind trial. You go into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you go into. And neither will you or your doctor know which treatment you have. But during the trial if necessary, your doctor can find out which treatment you are having.
The treatment groups are:
Giredestrant is a capsule. You take once a day every day.
Letrozole is a capsule. You take letrozole once a day every day of each cycle.
Palbociclib is a capsule or a tablet. You take palbociclib once a day every day for 3 weeks of each cycle. You don’t take it during the 4th week of the treatment cycle.
The dummy drugs are capsules. You take them once a day every day of each cycle.
Your doctor will tell you how many tablets or capsules you need to take.
You continue treatment as long as it is helping and the side effects aren’t too bad.
For women who haven’t gone, or are going, through the menopause and men
You also have a treatment to block the female sex hormone oestrogen. This is a luteinising hormone blocker (). You usually have this as an injection under the skin at the start of each treatment cycle.
Medication diary
You have a diary to fill in at home. You record when you have your medication and how much. You must bring the diary with you to all hospital appointments.
Quality of life
You fill in a few questionnaires:
• before you start treatment
• at regular times during treat
• and at 6 months and 1 year after finishing treatment
The questions ask about:
• your general health
• what daily activities you can do
• symptoms and side effects
These are quality of life questionnaires.
Research samples
You give blood samples during the trial. The trial team use these to find out:
You see the doctor for tests before taking part. These tests include:
You see the doctor during treatment at regular times. This is for blood tests and to see how you are.
You have a bone scan every 6 months until your cancer starts to get worse.
You have a CT scan or an MRI scan every 3 months until your cancer starts to get worse.
You see the doctor a month after your last treatment. This is to see how you are and for:
You then see the doctor every 6 months.
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 might be side effects we don’t know about.
The possible side effects of giredestrant include:
We have information on:
Your doctor or a member of the trial team will talk to you about the side effects of all the treatments in this trial before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Catherine Harper-Wynne
Roche
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”