Hi, I think this is another one of the SERD clinical trials for people who have already been taking an oestrogen blocker for a while? I have been approached to take part in one of the other studies, which is mostly recruiting from sites based in the North of England. Are you located in the South, or South East?
Thanks so much for your response. I’m South East and yes, sounds like the same.
The drug is Elacestrant and half those taking part will take this instead of their oestrogen blocker and the other half will continue with their normal meds. Does this sound similar?
Are you going to go for it?
I'm in two minds… finished Abemaciclib in Jan and coping really well on Exemestane and Zoladex. Feel normal! Worried about how this may change if I’m allocated the new drug but if it helps change the future of treatment… and potentially helps my outlook… xx
Here’s a bit of an info dump on the study/clinical trial. It’s sounds quite a promising drug…
Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized,
WHAT IS THE PURPOSE OF THE STUDY?
A clinical research study is an experimental medical investigation designed to answer specific questions about potential new or existing medications. These questions may include how safe and effective a certain medication is or what the best dose is. All new medications must undergo testing in studies before they can be prescribed by doctors. With clinical research studies, new medications can be developed and medical advances can be made.
This is a phase 3 study which means it involves a large number of participants and compares the study medication to the standard of care treatment. This study will be carried out at multiple locations in North America, South America, Europe, Middle East, Asia and Oceania for a total of approximately 30 countries. Approximately 4220 study participants are expected to take part.
For early-stage breast cancer, there are different treatment options. One of these is endocrine herapy, also called hormone therapy, which is the type of treatment you're currently receiving (hereinafter referred to as standard of care [SoC]). Endocrine therapies work by blocking hormones from reaching the cancer cells or by reducing the amount of hormones the body makes. In this study, we are testing a new endocrine therapy, called elacestrant. Elacestrant is an endocrine therapy that stops hormones from attaching to cancer cells and helping them grow. Researchers would like to understand if switching from SoC to elacestrant (the study drug) will help to slow down or stop thE growth of cancer more effectively and safely than SoC therapy.
WHAT MEDICATION IS BEING TESTED?
The Sponsor has developed the study medication, elacestrant.
Throughout this participant information sheet and informed consent form, elacestrant will be referred
The study drug belongs to a group of medications called selective oestrogen receptor degraders.
These medications work by blocking and destroying the oestrogen receptors. This prevents oestrogen from encouraging cancer cell growth in malignant cells and promoting tumour growth. The study drug is a new medication that has already been approved by the regulatory authorities in some countries for the treatment of advanced/metastatic oestrogen receptor positive breast cancer.
The study drug is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for treatment in ER+/HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation. As of the 19th December 2024, it has been recommended by NICE (the National Institute for Health and Care Excellence) for use in the NHS in patients with an ESR1 mutation and who have previously had at least 12 months of treatment with CDK4/6 inhibitor and endocrine therapy.
Yes, this is similar to the trial I have been invited to consider. I know what you mean about being in two minds. I have read the 32 page patient information form and the preliminary tests that you have to go through are scaring me a bit. Several scans (heart, dexa, as well as CT or other body scans). I have just arranged a telephone appointment to discuss things with the trial nurse.
It’s a lot to take in, isn’t it! Good plan re chatting to the nurse. The nurse I have spoken to has said that you can pull out at any point, no questions asked. Guessing the extra monitoring would be good - I’m just worried about lasting side effects, if I’m allocated the new drug etc…
Mmm … we just don’t know. I think I’m a bit, maybe more than a bit, older than you (I’m 63) so I tend to think about that slightly less. I’m more interested in if there are lasting benefits, but I guess that we don’t know that either. When would you start, if you decide to go ahead? X
Only a little bit! I’m 43 and have 10 and 13 year old boys so conscious that I want to take all the drugs offered to protect me but don’t want to have limiting side effects that make me miss out on every moment… just in case!
They’ve offered me an appointment with the research Dr to go through paperwork etc next Tues. Not sure when medication would actually start as need to have all the copious tests etc beforehand…
Speaking to nurse again today so can ask a few more Qs re timescales and will let you know…
I don’t know them yet. I’m still at the gathering info stage. I’m going to be asking a lot about the timings of the pre-drug tests - how many visits are needed and can some tests be done on the same day to make life a tad easier.
My son is 23, so not as young as your children, but still not old, so I completely understand what you say about taking everything you are offered.
Feel free to send me a friend request - my hospital mentioned that it’s good for trial patients to link up with one another if they have the opportunity to. X
Oh wow that’s amazing. How did you get on this, do they just send eligible people a letter in the post after contacting the hospital to see who has what?
