“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."
A study looking at olaparib, AZD6738 and AZD1775 for triple negative breast cancer (VIOLETTE)
This study is comparing olaparib on its own and in combination with AZD6738 for triple negative breast cancer that has spread.
To take part in the study, the team want to know if your cancer has changes (
This study was also looking at AZD1775 in combination with orlaparib. But this combination is no longer been used.
More about this trial
- olaparib and AZD6738
Who can enter
- have triple negative breast cancer
- are willing to have a sample of your cancer tissue tested for changes in the HRR protein
- have triple negative breast cancer that has spread to another part the body (metastatic) or has spread into the surrounding tissue and can't be cured
- have had at least 1 and no more than 2 chemotherapy treatments that included an
anthracyclinedrug, such as doxorubicin or epirubicin, and, or a taxanedrug, such as paclitaxel or docetaxel, since the cancer has spread
- have at least 1 area of cancer that can be measured on a scan
- have satisfactory blood test results
- are able to do everything apart from heavy physical work (performance status 0 or 1)
- are able to swallow tablets or capsules
- are willing to use 2 reliable types of contraception during treatment and for at least 6 months after if there is any possibility you or your partner could become pregnant
- are at least 18 years old.
- have breast cancer that has
HER2proteins (is HER2 positive)
- have breast cancer that has receptors for the hormones
oestrogen(ER positive) or progesterone(PgR positive)
- have cancer that has spread to the brain or spinal cord unless it has been treated with radiotherapy at least 3 weeks before starting treatment in this study and you have no severe side effects. If you are taking steroids it must be a low dose (less than 10mg a day) and have started at least a month ago
- have cancer that is pressing against your spinal cord (
spinal cord compression) unless it has been successfully treated and there has been no sign of it for at least 28 days
- have had chemotherapy, hormone therapy or a targeted cancer therapy within 3 weeks of starting treatment in this study
- have already had treatment with olaparib or similar drug (a PARP inhibitor) unless it was for less than 3 weeks and was finished at least a year ago
- have another cancer apart from
non melanoma skin cancer, successfully treated carcinoma in situof the cervix, DCIS, early endometrial cancer or any other solid tumour that was successfully treated and there has been no sign of the cancer for at least 5 years, including lymphoma that didn’t affect the bone marrow
- have had a targeted cancer drug as part of a clinical trial in the past 30 days, for an
immunotherapyit is 42 days
- have had heart problems such as congestive heart failure, heart attack or angina that isn’t controlled by medication in the past 6 months or your heart isn’t working well enough
- are taking medication or any other substances that affect the CYP enzymes unless they can be stopped before starting treatment
- have had major surgery within 2 weeks of starting treatment or you haven’t recovered for previous surgery
- still have moderate to severe side effects from any previous cancer treatment apart from hair loss and nerve damage (peripheral neuropathy)
- have HIV
- have hepatitis B or hepatitis C
- have a problem with your
digestive systemthat can affect how well you absorb tablets or capsules
- are allergic to the drugs, or any of their ingredients, used in this study
- are pregnant or breastfeeding
- olaparib and AZD6738
- olaparib and AZD1775 - closed
You have treatment in cycles.
Every 4 weeks is a cycle of treatment. Olaparib tablets are taken twice a day every day.
You can take them with food (a light meal) or without food. You have to take them 12 hours apart.
AZD6738 and olaparib
Every 4 weeks is a cycle of treatment.
AZD6738 are tablets you take once a day.
You take them for the 1st week (7 days) of each 4 week cycle. You must not eat or drink anything, apart from water, for at least 2 hours before taking the tablets and for at least an hour after.
You also take olaparib tablets twice a day every day.
AZD1775 and olaparib
The panel monitoring the safety of people in the study recommended to stop using AZD1775. This was due to the side effects. So people are no longer being put into this group.
Everyone in this group could continue having orlaparib only.
- before starting treatment
- then every 8 weeks while having treatment
- when you have tests to see if you can join the 2nd part of the study
- after you are put into your treatment group for the 2nd part of the study
- you have severe side effects
- your side effects aren’t getting any better
- your side effects are getting worse
- a drop in blood cells causing an increased risk of bruising, bleeding and getting an infection
- reduced appetite
- feeling or being sick
- problems with
- muscle weakness
- irregular heart beats
- fits (seizures)
- a high temperature with a low white blood cell count (febrile neutropenia)
- problems with your mouth, stomach, bowels and rectum (digestive system)
- changes to the way your liver works
- changes to the way your heart works
- drop in blood pressure
- your skin might be more sensitive to sunlight
How to join a clinical trial
Professor Andrew Tutt