A trial looking at olaparib with chemotherapy for early breast cancer (PARTNER)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2/3

This trial is comparing olaparib and chemotherapy to chemotherapy alone for triple negative breast cancer or breast cancer with a change in the BRCA gene.

BRCA breast cancers can be either triple negative or oestrogen positive.

Triple negative breast cancers 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

Surgery is often used for early breast cancers Open a glossary item.

Sometimes you have chemotherapy before surgery. This is called neo adjuvant chemotherapy. It can shrink the cancer and make the surgery more successful.       

In this trial, researchers are looking at whether adding a drug called olaparib (also called Lynparza) improves neo adjuvant chemotherapy.

Olaparib is a type of biological therapy called a PARP-1 inhibitor.  PARP is a protein that helps cells to repair. Doctors think that olaparib can stop the cancer cells from repairing themselves.

In this trial, people have 1 of the following:

  • chemotherapy
  • chemotherapy with olaparib

The chemotherapy drugs used in this trial are:

  • paclitaxel
  • carboplatin

These are commonly used to treat breast cancer but are not routinely used to treat early breast cancer. Doctors want to use them in this trial because research has shown that the combination of these drugs is a successful treatment.

The main aims of the trial are to:

  • find out how well olaparib and chemotherapy works as a treatment
  • learn about the side effects

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.

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

  • You have an invasive breast cancer  or inflammatory breast cancer
  • You have a triple negative breast cancer or a 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 it’s extending 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 Open a glossary item to diagnose your cancer less than 9 weeks ago
  • 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 this 
  • You are aged between 16 and 70 years old
  • You have satisfactory blood tests results
  • You are able to swallow and absorb tablets
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant  

You cannot join this trial if any of these apply.

  • 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. Your doctor will check this if needed
  • Your cancer has spread to other parts of the body (metastases)   
  • You have myelodysplastic syndrome or acute myeloid leukaemia  
  • You have had chemotherapy or a biological therapy in the past 5 years  
  • You have had another cancer in the last 5 years apart from successfully treated non melanoma skin cancer , very early cancers (carcinoma in situ Open a glossary item) of the cervix and breast, or a low grade early cancer of the womb
  • You are not able to have chemotherapy before surgery (neo adjuvant chemotherapy) for any reason
  • You have had a major surgery in the past 4 weeks and still have side effects from it 
  • You have had a whole blood transfusion 4 months before you have had the BRCA test, unless it was a red blood cell or a platelet transfusion
  • You have any moderate or severe condition that affects your nerves called sensory-motor neuropathy   
  • You have seizures that are not controlled by medication
  • You take drugs that affect some enzymes called CYP3A4
  • You have severe heart problems that are not controlled by medication such as an irregular heart beat (arrhythmia), a heart attack in the last 12 months or you (or someone in your family) has a disease called long QT syndrome
  • You are known to be sensitive to olaparib, carboplatin, paclitaxel or anything they contain
  • You have hepatitis B or hepatitis C
  • You have HIV
  • You have any other serious medical condition or mental health problem that the trial team think could affect you taking part 
  • You are pregnant or breastfeeding

Trial design

This is an international phase 2/3 trial. Researchers need about 527 people to take part worldwide.

This trial is in 2 parts. The treatment you have depends on the part you join.  In part 1 the doctors are looking at the best way to have olaparib. Once they know this they will start part 2.

Part 1 is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • chemotherapy
  • chemotherapy with olaparib on days -2 to 10
  • chemotherapy with olaparib on days 3 to 14

Neither you nor your doctor can choose which group you are in.

Diagram showing PARTNER randomisation

The day you start chemotherapy is called day 1. Some people will start taking olaparib 2 days before starting chemotherapy. This is called day -2.

Chemotherapy
You have paclitaxel and carboplatin on day 1. You have them as a drip into a vein. It takes about 2 to 3 hours.

You have paclitaxel on days 8 and 15.

On day 22 you have paclitaxel and carboplatin again (this is a treatment cycle). You have 4 treatment cycles with paclitaxel and carboplatin.

After this, you have 3 treatment cycles with an anthracycline Open a glossary item chemotherapy. Your doctor can tell you more about this.

Chemotherapy with olaparib on days -2 to 10
You start taking olaparib 2 days before chemotherapy.

Olaparib are tablets you take every day, twice a day. You take them for 12 days. Then you have a break of 9 days.  

You have paclitaxel and carboplatin on day 1. You then have paclitaxel on days 8 and 15.

On day 22 you start a new treatment cycle. You have 4 treatment cycles with olaparib, paclitaxel and carboplatin.

After this, you have 3 treatment cycles with an anthracycline chemotherapy. Your doctor can tell you more about this.

Chemotherapy with olaparib on days 3 to 14
You have paclitaxel and carboplatin on day 1. On day 3 you start taking olaparib. You take them for 12 days.

You have paclitaxel on days 8 and 15. And on day 22 you start a new treatment cycle. You have 4 treatment cycles with olaparib, paclitaxel and carboplatin.

After this, you have 3 treatment cycles with an anthracycline chemotherapy. Your doctor can tell you more about this.

Quality of life
You will be asked to complete a quality of life questionnaire:

  • before starting treatment
  • at set times during treatment
  • at set times after you finish your treatment

It asks about how you have been feeling and what side affects you have had. You do not have to agree to this research if you don’t want to. You can still take part in the trial.

Blood tests
You have some extra blood tests as part of this trial. The researchers want to:

  • find out if your cancer has a change in the BRCA gene
  • look for other gene changes

You have the blood tests before and after your treatment.

Hospital visits

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

You see the trial doctor for blood tests and a physical examination every 3 weeks.

You have an ultrasound scan or an MRI scan:

  • after 4 treatment cycles
  • after you finish all your chemotherapy

When you finish your treatment, you see the trial team:

  • every 6 months for the first year
  • then every 12 months for 10 years (the trial team may phone or email you instead of a hospital visit) 

Side effects

The trial team monitor you during the time you have treatment and you will be given 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:

We have more information on olaparib.  

We also have information on:

Location

Bedford
Berkshire
Bournemouth
Bristol
Bury St Edmunds
Cambridge
Cardiff
Colchester
Kidderminster
London
Nottingham
Oxford
Peterborough
Redditch
Romford
Southampton
Winchester
Worcester

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

Other information

This is Cancer Research UK trial number CRUKE/14/048.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14320

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

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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