A trial looking at carboplatin or docetaxel chemotherapy for advanced genetic breast cancer (BRCA trial)

Who can enter

You can enter this trial if you

• Have breast cancer that has spread (metastasised) to another part of the body
• Are due to have chemotherapy (you can still enter if you have had one or two courses of chemotherapy already but your cancer has started to grow again)
• Have a faulty BRCA 1 or BRCA 2 gene
• Are well enough to take part in the trial
• Have satisfactory blood test results
• Are prepared to use reliable contraception if there is chance you could get pregnant

You cannot enter this trial if you

• Have not had a genetic test that showed you have a fault in your BRCA 1 or BRCA 2 gene
• Have cancer that has spread to the bones only and can be treated with hormone therapy
• Have cancer that has spread to either your brain or your bones only and cannot be seen on scans anywhere else in your body
• Have had treatment with a platinum drug (carboplatin or cisplatin) before
• Have had a taxane drug (paclitaxel or docetaxel) in the last year
• Are allergic to platinum compounds, manitol or taxanes
• Have numbness or tingling in your hands or feet (peripheral neuropathy)
• Have had any other cancer in the last 10 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
• Have any other serious medical condition
• Are pregnant or breast feeding

Trial design

This is a phase 2 trial. It will recruit 148 patients - 74 with a BRCA 1 fault and 74 with a BRCA 2 fault.

It is a randomised trial. The people taking part will be put into one of two groups by a computer. Neither you nor your doctor can decide which group you are in. For every three people that take part two will be in group 1, and one will be in group 2. This is called a 2:1 (two to one) randomisation.

Group 1 will have carboplatin chemotherapy, though a drip into a vein, once every 3 weeks. This takes a few hours each time. Each 3 week period is one cycle of chemotherapy. You will have up to 6 cycles.

Group 2 will have docetaxel chemotherapy, through a drip into a vein, once every 3 weeks. This takes about an hour each time. Each 3 week period is one cycle of chemotherapy. You will have up to 6 cycles.

You will have a CT scan after 3 cycles of chemotherapy. If this shows that the treatment is not working, you will swap to the other drug. For example, if you are in group 1 and your cancer continues to grow despite having carboplatin, you will have docetaxel rather than carboplatin for up to 6 cycles. And vice versa.

If the treatment is working well you may go on to have another 2 cycles of treatment (8 cycles in total). But this depends on your individual situation and the policy at your hospital.

The research team would like to take a blood sample to use in research in the future. They would also like to keep a small bit of the tissue from your original biopsy (you don’t need to have any extra biopsies taken). But you don’t have to agree to this. You can still join the trial even if you decide not to give blood or tissue samples.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

• Blood tests
• Urine test
• CT scan
• Physical examination

You may also have a hearing test, a chest X-ray or a heart trace (ECG).

You will go to the out patients department once every 3 weeks for chemotherapy. You will have blood tests before each cycle of chemotherapy. You will have a CT scan and a physical examination after 3 cycles and 6 cycles.

After you finish treatment you will see the doctors, have a CT scan and a physical examination every 3 months for 3 years. You will see the doctors every 3 months or so after that (this will vary a bit between hospitals).

Side effects

The most common side effects of carboplatin are

• Feeling or being sick
• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Kidney damage (you will have tests to make sure your kidneys are able to cope with the drug)
• Loss of fertility

The most common side effects of docetaxel (Taxotere) are

• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Swelling of hands and feet due to fluid retention
• Rash
• Hair loss
• Sore mouth
• Diarrhoea

There is more information about both carboplatin and docetaxel on CancerHelp UK.