A trial of rucaparib for triple negative breast cancer or breast cancer with BRCA gene faults (RIO)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called rucaparib to treat triple negative breast cancer. It is also open to people with breast cancer caused by a fault in the 
gene or gene.
If breast cancer doesn’t have receptors for the hormones oestrogen or progesterone, or for the protein HER2, it is called triple negative breast cancer. This trial is supported by Cancer Research UK.
More about this trial
Doctors can treat triple negative breast cancer and breast cancer with a faulty BRCA gene the same way as other breast cancers. But researchers are always looking for better treatments for these breast cancers.
Rucaparib is a type of biological therapy called a PARP inhibitor. It works by blocking an called PARP, which helps damaged cells repair themselves.
Cancer cells with the BRCA gene fault already have problems repairing themselves. The researchers hope that by stopping PARP from working, cancer cells with the BRCA gene fault won’t be able to repair themselves and will die.
We know from research that triple negative breast cancer may also respond to a PARP inhibitor.
In this trial people with that is triple negative breast cancer or breast cancer with a BRCA gene fault will take rucaparib for a short period of time before they have chemotherapy for their breast cancer or surgery to remove their breast cancer.
The aims of the trial are to see
- How well rucaparib works for people with triple negative breast cancer or who have breast cancer with a BRCA gene fault
- If doctors can identify which people with breast cancer may benefit most from having rucaparib
Who can enter
You may be able to join this trial if all of the following apply
- You have been diagnosed with breast cancer that had started in the breast (primary breast cancer). If you have just been diagnosed and your cancer has already spread to another part of the body you may also be able to take part
- You have triple negative breast cancer or you have a fault in the
BRCA 1 gene or BRCA 2 gene - Your cancer is at least 1½ cm across or if less than 1½ cm across your cancer has spread to the
lymph nodes in your armpit - A sample of tissue (
biopsy ) can be taken from your cancer or a sample of tissue that has been previously taken and the researchers can use - You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 1 month afterwards for women and 4 months afterwards for men
- You are at least 16 years old
You cannot join this trial if any of these apply. You
- Are having, or had, any treatment for your current breast cancer
- Have had another cancer in the same breast in the past 5 years
- Have had treatment for another cancer in the past year apart from basal cell skin cancer or carcinoma in situ of the cervix
- Have already had rucaparib or a similar drug (the trial team can tell you this)
- Have had an experimental drug within 4 weeks of agreeing to take part in this trial
- Are taking certain medications that can affect how rucaparib works (the trial team can advise you about this)
- Have certain heart problems (the trial doctor can tell you about this)
- Have another medical or mental health condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 91 people to join. Everyone taking part will have rucaparib.
Rucaparib is a tablet. You take 5 tablets twice a day for 12 to 14 days. How long you take it will depend on when you start chemotherapy or have surgery. If you are having chemotherapy you need to finish rucaparib at least 3 days before starting chemotherapy.
The researchers will ask for up to 2 samples of cancer tissue () before you start rucaparib. These samples may be taken from a biopsy you had when you were were diagnosed. If this isn’t available then the trial team will take the samples before you start rucaparib.
They will also ask for another 2 samples of tissue after stopping rucaparib. If you are having surgery, your surgeon will take these during your operation. If you are having chemotherapy, your doctor will arrange for these to be taken.
The trial team will also ask for some extra blood samples. They will use these samples to find out how well your cancer responds to rucaparib.
Hospital visits
You see the doctor to have some tests before taking part. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - Ultrasound of your breast and lymph nodes in your armpit
A week after starting rucaparib a member of the trial team will phone you to see how you are.
Before you have surgery or start chemotherapy you see the doctor again for a physical examination and blood tests.
A month after stopping rucaparib you see the doctor for a physical examination and blood tests. They will then tell you how often they want to see you.
Side effects
Rucaparib is a new drug and there may be side effects we don’t know about yet. The most common side effects of rucaparib reported so far includes
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Diarrhoea or constipation
- Loss of appetite
- Weight loss
- Taste changes
- A change to the way you liver works
- An increase in the level of cholesterol in your blood
- Tiredness (fatigue)
- Feeling weak
- Dizziness
- Headaches
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
Dr Nicholas Turner
Supported by
Cancer Research UK
Clovis Oncology Inc
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
Other information
This is Cancer Research UK number CRUK/12/034.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
