A trial of hormone therapy and abemaciclib for early breast cancer (POETIC A)
Cancer type:
Status:
Phase:
This trial is looking at a drug called abemaciclib for women whose hormone therapy might not work so well.
The trial is for women who:
- have
early breast cancer 
and are due to start treatment - who have been through the
menopause
Cancer Research UK supports this trial.
More about this trial
It is usual to take hormone therapy for at least five years after surgery for early breast cancer. This reduces the risk of the cancer coming back. In some people these drugs stop working. This is because their cancer develops resistance to hormone treatment.
Researchers want to improve treatment for these people. In this trial they are looking at a drug called abemaciclib. It is a type of . It works alongside hormone therapy to stop breast cancer cells from growing and dividing. It is already used as a treatment for breast cancer that has spread and for certain high-risk forms of early breast cancer.
There are 2 parts to the trial. Part 1 was to identify those who might develop resistance to hormone therapy. To find this out the trial doctor tests your breast cancer cells for a marker called Ki-67.
Part 2 is the treatment part. It is looking at abemaciclib in combination with hormone therapy. This part is only for people who have a higher chance of developing resistance to hormone therapy.
The main aims of this trial are to:
- check whose breast cancer might not be as sensitive to hormone therapy
- see if adding abemaciclib to standard hormone therapy works better than hormone therapy on its own for this group of people
- see who benefits most from abemaciclib
- learn more about the side effects
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
Part 1 of the trial has now closed. You may be able to have treatment in Part 2 of the trial, if all of the following apply. You:
- have already joined part 1 of the trial and have had 10 days to 6 months of anastrozole or letrozole before your surgery for breast cancer
- are willing to give a sample of tissue (taken during your surgery) for the trial team to do some tests on
- have a high Ki-67 level in your breast cancer cells after 2 weeks to 6 months of having a type of hormone therapy called an
aromatase inhibitor - are suitable to have abemaciclib. The trial doctor checks this.
- have had surgery for your breast cancer and there are no signs of cancer in the surrounding tissues
- have had a sentinel node biopsy or you have had your
lymph nodes removed - have completed your chemotherapy if you had this and all the side effects are better. This doesn’t include some side effects such as hair loss.
- have completed your radiotherapy if you had this and you don’t have any side effects apart from mild ones
- can swallow tablets or capsules
- have satisfactory blood test results
- intend to take hormone therapy for 5 to 10 years
Who can’t take part
Cancer related
You can’t join the trial if any of the following apply. You:
- have cancer that has spread to surrounding tissues and can’t be removed with surgery or it has spread elsewhere in the body
- have cancer in both breasts
- have a different area of cancer in the breast that might be separate cancers
- have had or are planning to have abemaciclib or you have had a drug that works in a similar way to abemaciclib outside of this trial
- started hormone therapy more than six months before your surgery
Medical conditions
You can’t join the trial if any of the following apply. You:
- are taking hormone replacement therapy (
HRT ) within 4 weeks of planned surgery. This includes creams. - have had a blood clot anywhere in the body such as the lung or leg
- have HIV, hepatitis B, hepatitis C or any other active infection that needs treatment
- have a serious medical condition that the trial team think might affect you taking part. This could be kidney problems, breathing problems or
heart problems . - have had a major surgery in the 2 weeks before starting treatment
Trial design
This is a phase 3 trial.The team had hoped to find at least 8,000 people to join part 1. And of those, 2,032 people to join part 2. Part 1 of the trial had to close early because it was not recruiting enough people. Part 2 remains open for people who have already joined part 1.
Part 1 (registration - closed to recruitment)
Everyone taking part has hormone therapy before surgery, for at least 10 days before surgery and for up to 6 months. The type of hormone therapy used is called an aromatase inhibitor. This is either a drug called letrozole or anastrozole.
The team check a sample of tissue taken during surgery. They look at a marker in your cancer cells called Ki-67. It tells the team how quickly your cancer cells are growing and dividing. Hormone therapy is working if the Ki-67 level drops a lot after 2 weeks of treatment.
You are less likely to be sensitive to hormone therapy if the Ki-67 level doesn’t drop very much. This means you are suitable to join the part 2 of the trial. Part 2 is the randomised treatment part of the trial.
Part 2 (treatment - this part is open)
Only people who have high Ki-67 levels go into the second part of the trial.
This part of the trial is randomised. A computer puts you into a treatment group. Neither you nor your doctor can decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
- hormone treatment
- hormone treatment and abemaciclib
Before you start this treatment, you will have to have completed your usual cancer treatments as planned. This might include chemotherapy and radiotherapy. Once these are complete, your trial doctor may need to check that it is still safe to treat you within the trial. You have some blood tests before you start your treatment.
You may have already restarted your hormone therapy. You might be taking an aromatase inhibitor or another type. For those who haven’t restarted, the trial doctor tells you which hormone therapy to take. You have this for 5 to 10 years.
Abemaciclib is a tablet. You take them twice a day, everyday. The trial doctor tells you how many to have. You take them for up to 2 years as long as treatment is working and the side effects aren’t too bad.
Samples for research
The team ask for a sample of tissue () from your surgery.
They also ask you to give extra blood samples at specific times. Where possible you have them at the same time as your routine samples. The team plan to use these to look for circulating tumour .
Hospital visits
You see a doctor and have some tests before you start trial treatment. These include:
physical examination - blood tests
During treatment you have regular blood tests and check ups with the trial team to see how you are getting on.
You have a mammogram or MRI scan once a year.
After you finish treatment with abemaciclib you see the trial doctor 1 month later.
Follow up
After starting treatment you also have check ups at:
- 3 years
- 4 years
- 5 years
You don’t have these follow up visits if your cancer comes back within 2 years of treatment. Your doctor will talk to you about other treatment options.
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.
Abemaciclib is a new drug for early breast cancer. It has already been approved for people with higher risk or advanced forms of breast cancer. But there might be some side effects we don’t know about yet.
The most common side effects of abemaciclib and hormone therapy include:
- chills or fever
- diarrhoea
- infections
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- dry mouth or inflammation of the mouth and lips
- feeling or being sick
- hair loss
- tiredness (fatigue)
- feeling dizzy
- skin rash or itchy skin
- changes to blood tests that show how the liver is working
You might develop a lung problem called or interstitial lung disease. This is a serious inflammation of the lungs. You should tell your trial doctor or nurse as soon as possible if you have shortness of breath, a cough, or a fever. You may have some tests to check what is causing these symptoms.
We have information about:
Location
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.
Chief Investigator
Professor Stephen Johnston
Supported by
Cancer Research UK
Institute of Cancer Research (ICR)
Lilly Oncology
Other information
This is CRUK trial number CRUKE/19/008.
The Institute of Cancer Research have made a short video about the treatment part of the trial (part 2). You can watch it here.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
