A trial looking at AZD6738 and durvalumab for early breast cancer (PARTNERING)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2

This trial is for people who are already taking part in the PARTNER trial. It is for people with triple negative breast cancer, or breast cancer with a change in the BRCA gene.

Triple negative breast cancer are cancers that don’t have receptors to:

oestrogen
progesterone
HER2

Cancer Research UK supports this trial.

More about this trial

Chemotherapy before surgery is a common treatment for early breast cancer Open a glossary item

. This treatment can shrink the cancer and make surgery more successful. It is called neoadjuvant treatment.

Doctors would like to know whether a different combination of cancer drugs can help to shrink the cancer even further before breast cancer surgery. In this trial, they are looking at AZD6738 and durvalumab

AZD6738 is a type of targeted drug. It blocks messages that tell damaged cancer cells to repair themselves.

Durvalumab is a monoclonal antibody. It seeks out cancer cells by looking for proteins on their surface and attaching to them. The immune system Open a glossary item

then recognises the cancer cells and kills them.

The main of this trial is to find out how well AZD6738 and durvalumab work as a treatment for early breast cancer.

Please note – you can only join this trial if you have had treatment as part of the PARTNER trial. And a biopsy Open a glossary item

after 6 treatment cycles Open a glossary item

showed that you still have cancer (residual disease).

Who can enter

The following bullet points list 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 had 7 cycles of treatment as part of the PARTNER trial
you have invasive breast cancer or inflammatory breast cancer
you have triple negative breast cancer or breast cancer with a change (mutation) in the BRCA gene
your cancer measures more than 10 mm in diameter, or is any size and has spread to the outside of the breast or the skin, or you have cancer in the lymph nodes around your breasts and armpits
you have had a biopsy less than 6 weeks before you started the PARTNER trial
you have had a biopsy after 6 cycles of treatment as part of the PARTNER trial and this showed that you still have cancer (residual disease)
your cancer has been tested for certain proteins (such as CK5/6 and EGFR) and for the number of white blood cells (tumour infiltrating lymphocytes score). Your doctor will check for this
you weigh more than 30kg
you have satisfactory blood tests results
you can swallow and absorb tablets
your heart is working well
you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
you are aged between 16 and 70 years old
you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply:

Cancer related

you have a very small breast cancer that is less than 10mm and have no lymph nodes in your armpit that are 10mm or more
you have a triple negative breast cancer with a high amount of receptors called androgen
you have a rare type of breast cancer such as adenoid cystic, apocrine, metaplastic, low grade adenosquamous or secretory carcinoma
your cancer has spread to other parts of your body (metastatic)
your cancer got worse (progressed) during treatment as part of the PARTNER trial
have had chemotherapy or a targeted cancer drug in the last 5 years apart from the treatment you had in the PARTNER trial
can’t have chemotherapy before surgery (neo adjuvant chemotherapy) for any reason
have severe side effects from previous cancer treatment as part of the PARTNER trial, apart from hair loss
have had treatment with AZD6738, durvalumab or any other similar drug
have had another cancer in the last 5 years apart from non melanoma skin cancer, an early cancer (carcinoma in situ ) of the cervix and breast, or a low grade early cancer of the womb that has been successfully treated
have myelodysplastic syndrome or acute myeloid leukaemia
have had a bone marrow transplant from a donor

Medical conditions

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

have fits (seizures) that aren’t controlled by medication
have moderate or severe problems with your nerves (neuropathy)
take drugs that affect enzymes called CYP3A4
have had a major surgery in the last month and still have side effects from it
take drugs that damp down your immune system (immunosuppressants) unless it is a very small dose
have heart problems such as an irregular heartbeat (arrhythmia), low or high blood pressure, or you have had a heart attack in the last 12 months
have problems with your immune system
have problems with the amount of blood that is taken up or circulates in your brain
have had a whole blood transfusion 4 months before you had the BRCA test, unless it was a red blood cell or a platelet transfusion
have HIV
have tuberculosis
have hepatitis B or hepatitis C
have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

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

are pregnant or breastfeeding
are sensitive to any of the drugs used in this trial or anything they contain
have had a live vaccine in the last month

Trial design

This is a phase 2 trial. Researchers hope that around 15 people from the UK will agree to take part.

You join this trial after you have had 7 cycles of treatment as part of the PARTNER trial. And a biopsy after 6 cycles showed that you still have cancer (residual disease).

Everyone taking part in the PARTNERING trial has AZD6738 and durvalumab

PARTNERING trial diagram

You have treatment in cycles of treatment that last 4 weeks. The first day of each cycle is called day 1.

You have AZD6738 as tablets that you swallow whole. And durvalumab as a drip into your bloodstream (intravenously).

You have 2 cycles of treatment, taking around 2 months in total. You have each cycle in the following way:

you have durvalumab as a drip into your bloodstream on day 1
you have no treatment from day 2 to 21
you take AZD6738 every day, from day 22 to day 28

You shouldn’t eat for at least 2 hours before taking AZD6738, and for at least an hour afterwards.

Blood tests

You have extra blood tests as part of this trial. Researchers want to look for certain genes Open a glossary item

that can help to tell how well the treatment works (pharmacogenomics).

You have the extra blood tests before the start of treatment and then:

at the end of cycle 1
at the end of cycle 2
after breast cancer surgery
between 2 and 4 weeks after surgery

Diary

You have a diary to record every time you take AZD6738, and if you have any side effects. The trial team will ask you to bring the diary to the hospital appointments.

Tissue sample

The trial team ask you for new tissue samples of your cancer. You have them:

at the same time you have breast cancer surgery or after treatment ends before surgery
if your cancer comes back

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

a physical examination
blood tests
heart trace (ECG )

You see the trial doctor on day 1 of each treatment cycle. You have blood tests, a physical examination, and a heart trace each time you see them.

When you finish treatment, you have breast cancer surgery. This is the same as your standard treatment. Your doctor can tell you more about what happens during the operation.

After the operation, you continue your follow up as part of the PARTNER trial. You see the trial team:

every 6 months for the first year
then every year for up to 10 years (the trial team may phone you or email you instead to check how you are)

Side effects

The trial team monitor you during the time you have treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of AZD6738 include:

tiredness (fatigue)
a drop in the number of blood cells causing an increased risk of infection, bruising or bleeding and breathlessness

The most common side effects of durvalumab are:

diarrhoea
skin rash and itchy skin
tiredness
cough
high temperature (fever)
feeling or being sick
loss of appetite
tummy (abdominal) pain
weight loss
swelling in the body due to extra fluid

The most common side effects of the combination of AZD6738 and durvalumab include:

feeling sick or being sick
constipation
tummy (abdominal pain)
diarrhoea
changes to how the liver works
low blood pressure
changes to heart rate and rhythm
cough and shortness of breath

We have more information about the side effects of durvalumab.

Location

Cambridge

London

Oxford

Peterborough

Southampton

Recruitment start:

01/04/2019

Recruitment end:

30/12/2025

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Jean Abraham

Supported by

AstraZeneca
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
University of Cambridge

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

13 December 2022

CRUK internal database number:

16141