I realised that I haven’t really talked about the clinical trial and what it is about exactly. At first it was because I wasn’t sure I could but having checked my paperwork, I don’t think there is anything preventing me from sharing my experience.
So the name of the trial is ARTemis: Avastin randomised trial with neo-adjuvant chemotherapy for patient with early breast cancer.
For the leymans, neo-adjuvant means “pre-surgery”. Avastin is the name of the drug that is tested.
How does it work?
Once you have agreed to go on the trial and all your test results are back – I had to do an extra ECG and blood tests – your name is entered in a computer for randomisation. You have 50% chances of getting Avastin and 50% of being in the control group (ie: without Avastin). I was randomised to the latter group.
How is it different from Standard Chemo treatment?
With a standard treatment I would have gotten 8 chemo session with a 3 drugs cocktail.
With the clinical trial, regardless of which 50% you are, I get 6 sessions with a 4 drugs cocktail. Which work this way for my group:
Docetaxel (or Taxotere) for 3 cycles every 3 weeks.
5-Fluorouracil, Epirubicin and Cyclophosphamide combined for 3 cycles every 3 weeks.
If I have been on the research treatment, I would have had Avastin added to the Docetaxel and with 1 cycle of the 2 lot of drugs, and then a final 2 cycle with drug cocktail 2 without Avastin.
What about the potential side effects?
This was my main concern and after checking both protocols and speaking with the clinical trial nurse, I decided that both standard treatment and clinical trial treatment had the same amount of risk/side effects. The benefit for me was that it was going to be over quicker and I was going to be followed up a lot more closely as they have to do more tests and measurements to check the effects of the treatment.
From what I understand I am on the last year of that trial as they are completing this year (or maybe next if they didn’t get enough participants) so results should be in in a couple years.
Of course I have no way of comparing whether this treatment is working better for me than a standard treatment but I feel fine. The side effects have so far been minimal and I have noticed a reduction of my lump…even if I haven’t the proof of that yet with an ultrasound (but I will in a couple weeks). So fingers crossed, I have made the right decision.