A trial of giredestrant (GDC-9545) for breast cancer (persevERA Breast Cancer)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

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 (oestrogen positive breast cancer Open a glossary item ). The people taking part also have cancer that had spread into the surrounding tissue or to another part of the body.

More about this trial

Women and men have the hormone oestrogen Open a glossary item 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 menopause Open a glossary item . 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:

giredestrant, palbociclib and a dummy drug (placebo )
letrozole, palbociclib and a dummy drug

The aims of this trial are to compare giredestrant and palbociclib with letrozole and palbociclib to find out:

which works best for ER positive breast cancer that has spread
more about the side effects are
how the treatments affect quality of life

Who can enter

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 spread into the surrounding tissue (locally advanced) or to another part of the body
have cancer that can’t be treated with the aim to cure
have oestrogen positive breast cancer
have HER2 negative breast cancer
have a recent sample of cancer tissue (biopsy ) that the team can ask for. If not you must be willing to give a new sample.
have not had treatment for your cancer spread
have an area of cancer that the doctor can measure on a scan
are active but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are post menopausal . Or you are willing to take a drug that stops the ovaries from making hormones LH blocker for the time you are in the study, if you are female.
are willing to take a drug to block the oestrogen in your body (LH blocker), for the time you are in the study, if you are male
had 2 years of an aromatase inhibitor hormone therapy for early stage breast cancer. You stopped treatment at least 1 year ago and your cancer has now come back.
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
are able to use an electronic device to record how you are feeling and any side effects that you are having

Who can’t take part

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

have ongoing side effects of previous cancer treatment. This is apart from hair loss and some mild side effects such as nerve damage.
have cancer that has come back during or within a year of finishing drugs called CDK4 or CDK6 inhibitors such as abemaciclib or ribociclib
have had fulvestrant or a drug that works in a similar way to treat your breast cancer
have had cancer treatment within 14 days of being put into a treatment group (randomised ) for this trial
have had an experimental drug or used an experimental device as part of another clinical trial within 28 days of starting trial treatment
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 and early (stage 1) endometrial (womb) cancer.
have cancer spread to the brain or spinal cord that is causing symptoms or getting worse
have cancer pressing on the spinal cord (spinal cord compression ). You might be able to join if this has been treated, is stable and you haven’t needed any medication within 2 weeks of being randomised.
have cancer spread that is at a risk of causing life threatening problems such as fluid around the lungs, heart or tummy (abdomen)

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

are taking medication that affects the CYP enzymes within 14 days of starting treatment
have had chest pain (angina) or a heart attack in the past year. Or any other heart problem that might affect you taking part.
have liver problems such as hepatitis B, hepatitis C or cirrhosis
have HIV
have problems with the digestive system such as inflammatory bowel disease or ongoing diarrhoea. This includes major surgery such as removing part of the stomach.
have had a recent serious infection
have any other medical condition or mental health problem that the doctor or the trial team think could affect you taking part

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

are sensitive or allergic to any of the drugs or their ingredients used in this trial
are pregnant or breastfeeding

Trial design

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, palbociclib and a dummy drug (placebo)
letrozole, palbociclib and a dummy drug

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You have treatment in cycles Open a glossary item

. Each cycle is 4 weeks.

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 (LHRH Open a glossary item ). 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:

what happens to giredestrant in the body
what effect giredestrant has on the body
about substances in the blood (biomarkers ) that might tell them how well treatment is working

Hospital visits

You see the doctor for tests before taking part. These tests include:

a physical examination
blood tests
urine test including pregnancy test (if you are able to become pregnant)
a biopsy so the study doctors can look at the cancer tissue. If a good enough sample is available already, the team will use this.
heart trace (ECG )
heart scan (ECHO or MUGA )
CT scan or an MRI scan
bone scan

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:

a physical examination
blood tests
heart trace

You then see the doctor every 6 months.

Side effects

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:

blood clots
changes to how your kidneys and liver works
diarrhoea
changes to the ovaries such as cysts and changes to the womb (uterus)
feeling or being sick
a slow heart beat
changes to the heart trace (ECG)
not being able to have children (infertility)
symptoms of the menopause such as hot flashes, mood swings, irritation and loss of interest in sex