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

Cancer type:

Breast cancer
Secondary cancers

Status:

Open

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 Open a glossary item)
  • 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 Open a glossary item 

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 Open a glossary item 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 Open a glossary item negative breast cancer  
  • have a recent sample of cancer tissue (biopsy Open a glossary item) 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 Open a glossary item. Or you are willing to take a drug that stops the ovaries from making hormones LH blocker Open a glossary item 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 Open a glossary item) 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 Open a glossary item of the cervix, non melanoma skin cancer Open a glossary item and early Open a glossary item (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 Open a glossary item). 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 Open a glossary item 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 Open a glossary item 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

 


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 Open a glossary item) 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 Open a glossary item 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 Open a glossary item)
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • 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:

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. 

Location

Brighton
Cardiff
Coventry
Leicester
London
Maidstone
Nottingham
Peterborough
Plymouth
Stoke-on-Trent
Sutton
Truro

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Catherine Harper-Wynne

Supported by

Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17442

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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