Track-ER Trial for ER/PR Positive HER2 Negative Breast Cancer

Hi FlowerN

I just wanted to reply to reassure you a little that whilst the side effects of Abemociclib are a bit scary when you read them there are some of us on here who are managing very well in taking it. I have been on the maximum dose for 6 months and my only symptom is the  odd runny tummy but I now know which foods trigger it and when is best to eat etc. The trials of Abemociclib have revealed promising data in relation to reoccurrence which helps me a little in handling an awful fear of reoccurrence. However i have also read about the TRAK ER trial and I can understand how that appeals. I suppose I just wanted to try everything I could now  to stop reoccurrence. I wish you well in taking your decision these things are never easy! 

Best wishes

Lizzie

Hi, it’s a tricky decision. I guess it’s balancing the opportunity of taking something immediately to mop up anything left after chemo/ radiotherapy with abemaciclib. The alternative is a 50 percent chance of getting two drugs which we don’t know yet if they work to mop up. If you get a positive tumour DNA test, showing that your cancer is still active, I would work through how you would feel if you were not given drugs on the trial. You would then just be having scans to look for when metastases appear and 3 monthly blood tests. 

if you get side effects on abemaciclib, you can always have a lower dose, without losing the benefit. 

it’s a tough one and only you can work out what is best for you xx

Hi, I'm taking abemaciclib, cycle 12. The trial of this drug has finished so I know I am getting a drug that gives me a good chance of not having a recurrance, & not a placebo. Also taking anastrozole 

I would have thought your oncologist could give you the info you are looking for? 

Best wishes x 

Thank you all for responding and for your support and words of reassurance.

A friend of mine actually had her initial 150mg dose reduced to 100mg ( and potentially wil be going down to 50mg) due to severe sickness and poor blood levels, resulting in her feeling overall much better,  although still with notable side effects.. So I acknowledge improvement can be achieved through reducing the dose whilst still maintaining the proven benefit of Abe ( or so they say), and as you say, its comforting knowing we have definitive data that has proven the benefit of Abe in reducing the risk of recurrence ( IDFS) when taken in combination with hormone therapy, by a good % ( was it 6.4%?). 

On the other hand,  its probably reasonable to assume that Palbociclib, being another CDK 4/6 inhibitor, same as Abe, will work in a very similar way, blocking those proteins and thus depriving any remaining cancer cells from food to further grow and devide... Of course, what we don't know is whether Palbociclib may in fact prove to be even more beneficial than Abe in reducing the risk of recurrence, and especially when given in combination with the other drug, or not... And of course, zephyr as you pointed out, it's 50/50 whether I happen to fall into the Palbociclib and Fulvestrant arm of the trial or not,  and if not - how would I feel knowing I have active cancer cells detected in my body whilst on hormone therapy, and potentially only then being able to change to a different hormone blocker that might be better,  whilst  "waiting" for the mets to show on one of the scans....not a very encouraging prospect .

Of course, I'll discuss it with my Oncologist In more detail in time, once chemo is over...last session tomorrow!!

I suppose it does now sound like taking the more certain approach backed by real life evidence is probably better ( i.e. going the Abe route),  but it's hard sometimes to know what to do for the best...hence I was also hoping I could also hear from someone taking part in that trial to hear their individual perspective too...

Thank you again

This link is very informative about the 2 drugs and I think it may help you to make a decision.  Take care and I wish that we all remain cancer free.  I love to learn all I can about the newest treatments etc as makes us empowered .  

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10217927/#:~:text=Using%20a%20univariate%20logistic%20regression,had%20a%203.37%2Dfold%20increased

Barbara

Thank you so much Hopeful Barb 

This is really helpful, and the most recent one I've seen. 

Thank you so much again 

Xx

Hi FlowerN,  you are so welcome and I know that all of us are here to help each other.  Each of us has so much to offer in different ways and sharing is so important.  All the ups and downs are not easy but with support comes strength.  Hugs to you and wishing you the best in the treatments.  
Barbara

Hello, I am on the TrakER trial. I had my fifth blood test yesterday. I was not offered Abemaciclib as by the time it had been licenced for early breast cancer I had already been taking Anastrazole for 10 months and this was well past the cut-off window. Xx

Just to add, and thank you @Hopeful Barb for providing the link, I think that the research looked at women who had already metastasised, but please do correct me if I am wrong. The TrakER trial is for participants who have not progressed to this stage (if that happens then you leave the trial and are treated outside of it). After your initial blood test, which is used in conjunction with your original tumour slide to design a personal liquid biopsy, further blood tests look for circulating tumour DNA, which cannot be picked up via a scan etc. If you test positive for this, then yes, you have the 50/50 chance of being assigned to the treatment or placebo arm of the study. They are looking at whether or not P and F halts progression at this stage. It has to be said that there are studies outside of drug trials, which report that not everyone who has circulating DNA progresses (although there is a high chance that they will) and it can take several months (sometimes a couple of years) before this happens. Hence the regular scans for those who have tested positive. I am guessing that if something is detected on a scan, then this would be at a very early timescale of stage 4, which would be useful clinically, I suspect. 

It’s a really hard decision for you, and others. I was not in a position of choice. Please also bear in mind that whilst abemaciclib had excellent results, it is not a magic wand. Trial data reported that some participants did develop recurrences whilst taking it. But again I stand corrected if I am wrong. Xx

Hi Cloudier 

Thank you for responding xx

• I believe you are right that the study above relates to patients with metastatic disease. I only skimmed through the article yesterday and focused on the conclusion, but then re-read it more carefully last night and yes, by talking about progression-free survival, etc, it does mean that patients already had cancer that had metastasised and the comparison centered on which one of the 3 x CDK 4/6 inhibitors was best at halting further progression. Whereas the TrakER trial looks at efficacy of P and F in combination, in preventing recurrence in patients with early breast cancer, in comparison with endocrine therapy alone.

Yes, talking about the Monarch trial and Abemaciclib for patients with early breast cancer, there were some recurrences, but I think the reduction of risk on comparison with endocrine therapy alone was around 6.4%, which is probably statistically significant I think ( I remember reading somewhere that oncologists generally think 5% benefit in treatment to be worthwhile).

So you are nearing half way point in the trial if you've just had your 5th 3 monthly blood test? I hope all remaining blood tests are negative for ctDNA for you Do you find it reassuring having these tests and just continuing to be monitored so closely after the end of active treatment? I think I would,  hence mine pondering over the decision of whether to go for the trial or start taking Abe.... But of course, there is that 50% chance of not getting the P and F combination as a treatment if a positive blood test is returned so that uncertainty makes it less appealing for me...Also, how many lymph nodes did you have affected in the beginning ( I had 3 of 15) and did you go for both chemo and radiotherapy?

Thank you