A trial looking at chemotherapy and a drug called AZD5363 for triple negative breast cancer that has come back or spread (PAKT)

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

Cancer type:

Breast cancer




Phase 2

This trial is looking at a drug called AZD5363 with paclitaxel chemotherapy for triple negative breast cancer that has come back after treatment or spread to other parts of the body. Triple negative breast cancer is breast cancer that doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2.

More about this trial

Doctors often use the chemotherapy drug paclitaxel (Taxol) for triple negative breast cancer.  But researchers are looking for ways to improve treatment for this type of cancer. In this trial, they are looking at a drug called AZD5363,

AZD5363 is a type of biological therapy. It stops signals that cancer cells use to divide and grow.

The aim of this trial is to see if AZD5363 and paclitaxel works as a treatment for triple negative breast cancer.

Who can enter

You may be able to join this trial if all of the following apply.

  • You are a woman who has been diagnosed with breast cancer that is triple negative and it has come back after treatment or spread to another part of your body
  • You can’t have surgery to cure your cancer
  • Your cancer can be measured using a scan
  • The trial team are able to get a sample of tissue from a biopsy Open a glossary item (tumour sample) taken when you were first diagnosed with cancer or when the cancer came back
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You are able to swallow capsules
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any chance you could become pregnant
  • You are at least 18 years old

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

  • Have had chemotherapy for cancer that has spread to another part of your body
  • Have had radiotherapy in the last 4 weeks if it included more than 30% of your bone marrow Open a glossary item (your doctors can advise you about this)
  • Have had drugs called PI3K inhibitors, AKT inhibitors or mTOR inhibitors
  • Have had either paclitaxel or docetaxel in the last 12 months
  • Have had any medication that affects the CYP3A4 enzyme in the last 2 weeks (your doctor can advise you about this)
  • Have had St John’s Wort in the last 3 weeks
  • Have had any other experimental drug in the last 4 weeks
  • Have cancer that has spread to your brain unless it has been successfully treated and you have no symptoms
  • Have nerve damage causing numbness or tingling in your hands or feet (peripheral neuropathy Open a glossary item)
  • Have a problem with your digestive system Open a glossary item that may affect how you absorb drugs (your doctor can advise you about this)
  • Have diabetes or higher than normal levels of sugar in your blood
  • Have problems with your kidneys (the trial team will test your urine and blood to check this)
  • Have had a heart attack in the last 6 months or have certain other heart or lung problems (your doctors can advise you about this)
  • Have another serious medical condition or mental health problem that the trial team think could affect your taking part
  • Are pregnant or breastfeeding

If you have cancer that has only spread to your bones, you may not be able to take part but the trial team will advise you.

Trial design

This phase 2 trial will recruit about 140 people in the UK. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have paclitaxel and AZD5363. People in the other group have a dummy drug (placebo Open a glossary item) and paclitaxel.

PAKT trial diagram

You have paclitaxel once a week for 3 weeks out of every 4. You take AZD5363 (or the dummy drug) twice a day for 4 days in each of these 3 weeks. You start taking it the day after you have paclitaxel. You then have a week without any treatment. Each 4 week period is called a cycle of treatment. You can have up to 6 cycles.

You can have paclitaxel and AZD5363 (or the dummy drug) until your cancer starts to grow, or the side effects become too much. If you need to stop either drug for any reason other than your cancer getting worse, you may be able to keep taking the other drug on its own. Your doctor would talk to you about this.

The trial team will provide a study diary that they will ask you to keep at home. In this, you write down when you take your tablets.

They will also ask you to fill in 4 questionnaires during your treatment. The questionnaires will ask you about any side effects you have and how you are feeling. This is called a quality of life questionnaire.

The researchers will ask you to have a biopsy Open a glossary item either before the treatment starts, or if your cancer gets worse. Studying these samples may help researchers learn more about how the treatment works. If you don’t wish to have this biopsy, you don’t have to. You can still take part in the trial.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

During treatment, you will have regular blood tests and urine tests to check your glucose (sugar) levels and to check your general health. Every 8 weeks you will have a physical examination and either a CT scan, MRI scan or X-ray. You will also have a bone scan and extra blood tests.

When you finish treatment, you see the doctor about a month later. You will have some blood tests and a CT or MRI scan.  The researchers will continue to check how you are every 3 months (unless you ask them to stop doing this). You will not need to go to hospital every 3 months as the researchers will either phone you, or check your medical records to see how you are.

Side effects

As AZD5363 is a new drug, there may be side effects we don’t know about yet. In trials so far the most common side effects have been

  • An allergic reaction
  • An increase in the amount of sugar in the blood
  • Diarrhoea
  • Skin rash
  • Tiredness (fatigue)
  • Feeling weak
  • Feeling or being sick
  • Shortness of breath
  • Loss of appetite
  • High temperature (fever)
  • Changes to the strength of your heartbeat and blood pressure
  • Changes to your liver and how it works
  • Dehydration Open a glossary item

The most common side effects of paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • An allergic reaction
  • Numbness and tingling in your hands and feet (peripheral neuropathy)
  • Feeling or being sick
  • A sore mouth
  • Diarrhoea
  • Tiredness (fatigue)
  • Hair loss
  • Joint and muscle pain
  • Skin rash
  • Taste changes
  • Headaches
  • Pain along the vein that is used to give you chemotherapy

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

Professor Peter Schmid

Supported by

Barts Health NHS Trust
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Queen Mary University of London

Other information

This is Cancer Research UK trial number CRUKE/12/051.

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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