A trial looking at olaparib, 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 Open a glossary item
  • progesterone Open a glossary item
  • HER2 Open a glossary item
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:
  • olaparib
  • AZD6738
  • durvalumab
Olaparib (Lynparza) and AZD6738 are 2 types of targeted drugs. They block 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 itemthen recognises the cancer cells and kills them. 
 
Everyone taking part in this trial has 1 of the following:
  • olaparib and AZD6738
  • AZD6738 and durvalumab
The main of this trial is to find out how well olaparib, 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) Open a glossary item 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 Open a glossary item 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 Open a glossary item
  • 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 Open a glossary item) 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 Open a glossary item  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 Open a glossary item in the last month 

Trial design

This is a phase 2 trial. Researchers hope that around 29 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 is put into 1 of the following treatment groups by computer:
  • olaparib and AZD6738
  • AZD6738 and durvalumab
Neither you nor your doctor can choose which group you are in.

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

Olaparib and AZD6738
You have olaparib and AZD6738 as tablets that you swallow whole. 
 
You have 2 cycles of treatment, taking around 2 months in total. You have each cycle of treatment in the following way:
  • you take olaparib twice a day, for a month 
  • you take AZD6738 every day, from day 1 to day 7
You shouldn’t eat for at least 2 hours before taking AZD6738, and for at least an hour afterwards.   
 
AZD6738 and durvalumab
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 olaparib and 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 asks you for new tissue samples of your cancer. You have them:
  • at the same time you have breast cancer 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 Open a glossary item)
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 olaparib are:
The most common side effects of AZD6738 include:
  • tiredness 
  • a drop in the number of red blood cells causing 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
We have more information about the possible side effects of olaparib

Location

Cambridge

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

Dr Jean Abraham

Supported by

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

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16141

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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