Hello everyone. Has anybody on this forum ever joined in a clinical trial? I have been invited to join a Phase 1 clinical trial for LOXO-783. The new drug is for those who have the PIK3CA mutation. At first I was very excited to join but when I was looking at the screening requirements, I don’t know if my body could take it. There’s a lot of blood sampling sometimes after 1 hour then after another hour and also a lot of scans, echocardiogram and other tests. Although it will be just for 28 days, I’m not sure I’ll survive 28 days of torture. Then after undergoing these tests, there is no assurance that I will be eligible to join.
For those who have joined clinical trials , did you have to undergo this very grueling screening test?
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MyMiracle13
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I just joined a Phase 1 trial in December. There’s a difference between us though because the drugs in the trial I’m on I’ve taken them before (used by many) , this is a different way of combining them. Joining a Phase 1 with a brand new drug is very different . This is the stage where they discover patients side effects to the drug, and what seems to be the max amount of drug administered that can be tolerated.
Is this pre-trial work for you only tests? And no drug at all? What are they giving you when they draw blood after an hr?
My first month started me with some of the drugs. I had first a bone scan, 2 CT scans and EKG. Bloodwork has been done either every week or 2 weeks(depending). Now in second month but 1st of all 3 drugs and bloodwork this month has been weekly and one more EKG. I’ll be having repeat scans in one more month. If my cancer seems to have progressed at all again, I’ll jump off the trial and regroup for recs, probably resorting to taking Afinitor . There may be another option for one more trial with a brand new drug Phase 2 for me but I’ll have to see where my cancer is at - I might decide I don’t have time to play with another trial (Plus I don’t have the details for that trial yet either)
Thank you so much for replying and for the the very useful information you shared. I am from the Philippines but the clinical trial is based in Singapore. Luckily my sister and my daughter live there so I won’t have a problem with accommodation. My transport expenses to and from the hospital in Singapore will be shouldered by the sponsor of the trial. So my biggest expense will be my flight expenses to Singapore and back to the Philippines. I have to stay in Singapore for a month for cycle 1 and for cycle 2 onwards just one or 2 days. Once again, thank you. You have been most helpful.
I have been in a clinical trial for arv471 plus Ibrance for over a year. Did pretty much what you are being asked to do at the front end then we got into a regular routine of once a month visit with blood draw at visit then CT scan every 3 months. It is a big commitment up front but becomes pretty routine after the front end stuff ends. I have found it very worthwhile and feel I am receiving excellent care.
Interesting. My trial also includes iBrance. I'm very interested to know if the arv471 is instead of Fulvestrant? And had you been on iBrance prior to starting that trial?
I do have a friend who bucked the trend and, after a surprise diagnosis of stage 4 BC at initial diagnosis, decided to join a Phase 1 trial. We thought she was taking serious risk (her family was against the idea) but she has a strong social conscience and I think that persuaded her to do it. I mean as guinea pigs we are paving the way forward for future women. (Like mine has been going a year I think but only a 1/2 dozen people have joined it, where I’m going!)
There are some seriously important questions to ask them first. Here is a list from Sloan. I’d try googling for other lists too and make your own by selecting the ones you deem as most relevant to you. The main ones are what are their expectations for YOU, and the types of risk you might face.
Actually this is a better list! Note about who pays for what too. (My friend paid for nothing while she was on her trial) I’m paying mostly co-pays for the doc visits.
Happy to discuss further. It’s not an easy decision. *** And it has to be weighed with the risks of your alternative treatment options.
Also, there’s a “benefit” to taking the opportunity to join a trial while you are eligible. If you go mainstream drug route for another treatment round - will you have more options to join this trial, or another one, down the road if you change your mind? Lots to consider! Also consider how many more standard care drug options you have left.
I would definitely write out a thoughtful list of questions to ask them plus, for yourself, a list of pros and cons of standard route vs. trial
My onc asked me if I wanted to participate in a trial and I believe she thought it would be a good idea. When reading the paperwork, it said that I may be held responsible for any and all costs. There was no way I was blindly signing up for anything like that!
HiI haven't participated in trial yet but I can understand your dilemma. These are the questions I'd ask myself:
Is the current treatment working?
What are the options if i don't participate in this trial?
If I don't take this opportunity now, will it be available to me in the future?
What are the side effects of the drug?
Could i/do I want to cope with them? leads back to 'what are the options '
...
I don't know the state of your mobility/day to day health which may be the reason youre unsure of whether you can cope with the tests. Only you can judge that. Though we do tend to find the strength when there's a goal in sight.
Whatever you decide, I wish you all the best x
Good morning!
I am currently in a phase oneB clinical trial at Dana Farber in Boston. This is my 8th PFS month! Dr. Lin suggested this trial after some progression on Ibrance and Falsodex. The purpose of this trial is to see what dosage of Ibrance will be given with the study drug ARV 471 (an oral SERD). I have bone mets, mostly spine and sacrum.
There was no pressure to join, but for me I thought what have I got to lose? If I progress I’ll come off and take my next line of treatment. So far I’ve gotten 8 extra months without having to use a new line, I consider that a win!
Yes, you usually have a flurry of activity in order to make sure you meet criteria and the trial is safe for you. Once accepted, the first month was weekly with labs and EKGs each visit. MD and research nurse visits each time. Scans every 2 months.
Months 2-6 had to be in Boston every 2 weeks with same testing, but less blood work. I did have a mediport placed because I have terrible veins, and only can use 1 arm for draws. That port has been a blessing.
Now monthly same labs , EKGs and MD visits. I have moved to scans every 3 months. I feel blessed to have done so well, and help future individuals.
As far as costs, I also signed that I was responsible for travel and lodging. I live in Central NY about 4 hours from Boston. We have family that we stay with so that has been nice.
I have not paid for anything else. I know if insurance balks at scans the study pays for them.
You surely need to have your questions answered, and make sure you understand the trial requirements before you agree.
It was the right choice for me, but I know it is not for everyone. Knowing that when and if progression occurs I can pull out and start the next treatment line made it easy for me. I look at this as 8 extra months so far, and I am so grateful.
Good luck with your decision. Let us know what you decide for yourself. There is no wrong decision if you do what you feel is best for you! ♥️
This is all very interesting to hear about. I took iBrance and Fulvestrant for 2 1/2 years before I started having symptoms and finally proof of progression. Than I was on Lynparza for a year but I was always wishing there was a way to know which of those two drugs failed for me so its great to hear you just basically changed the SERD and are getting all this extra time! My trial is Lynparza, Fulvestrant and iBrance all combined. Only been on that combo for a month but my TM did decline slightly just last week. Now I have to wait until Thursday though to learn if everything is ok with my bloodwork.
I’ve been watching that drug trial for the ARV471. I’m so happy to hear Shaesmom you are having a good response. Do you have any mutations?
I was in the Serena 6 trial at MAYO, where they test for ESR1 if they find ESR1 and if it presents without progression you go into the blind drug trial for cameszestrant an oral SERD. I unfortunately did get the ESR1 but experienced progression in T9 so I had to leave the trial. I’m now on Kisquali and faslodex. Glad more drugs are coming
When I had my liquid biopsy to test for the mutations, there was not enough tumor burden within my bloodstream to get results. I will be tested again if I progress. I am also very happy with the success I’ve had. Anytime we have PFS it’s a victory for us! How are you tolerating Kisquali? Do you have bone only Mets?
yes I am bone only, also Lobular. The switch from Ibrance to Kisquali so far has been easy. Going off Letrozole to faslodex was good as well. If this starts to fail I’ll go to elecestrant. I’m happy the ARV471 is doing good for you. Are you on a CDK 4/6 with the ARV471? Are you bone only as well?
I have been on a clinical trial at Sloan Kettering (Stage 2 Arm D) for almost two years and I am so thankful to have had this opportunity. Yes, in the beginning there are a number of tests and scans to make sure you meet the criteria, but if you qualify, the testing and monitoring decreases to (at least in my case) monthly labs and injections. EKGs are every other month and scans every 3 months. I was nervous to start as well, but I thought it was worth trying. When you think about it, FDA approved or not, all of these medications we are taking are trial and error for us right? What approved medication that works great for one patient can cause terrible side effects and/or progression in 3 months for another. Although it certainly can be very stressful to go through all of those tests, it was also, for me, a good thing to be that closely monitored. I’m always questioning what’s happening in my body, what is the cancer doing, so it did give me some peace of mind during that intrusive criteria phase. Hope this gives you another perspective. Good luck with your decision. 💕
Thanks so much for your reply. Yes I am apprehensive about joining this trial but if I don’t do it this time, I may not have another opportunity. I am also doing this for future MBC patients who may benefit from this drug
I was in a clinical trial at Dana Farber in Boston last year. Horrible outcome. My Onc told me about it and it was my decision to try this trial. The bloodwork and scans were not the issue. The results were. After 5 months, they discovered 2 very painful tumors in my spine!! I was sent back to RI hospital. It’s just my personal opinion but knowing my results, I never would have participated in this trial or any trial going forward. I could also go on about the treatment of the physician and NP but not enough time in the the day. I should have just stayed with my wonderful Onc at RI hospital
This is my third line of therapy. I am taking AZD9833 (Faslodex in pills) with Capivasertib. So far it has been working very well and I am extremely grateful to have access to drugs that are not FDA approved for commercialization yet.
Everything is paid by the sponsor which is also a huge perk especially here in the US. My onc told me “it’s an opportunity but also a big hassle”. She already had several patients on this clinical trial and told me it was very promising. Her input was really helpful.
I was lucky because I got the last spot in the study but it was the one people did not want because it required all the procedures… Before entering the clinical trial I had a bone and CT scans/labs/eyes exam/liver biopsy/echocardiogram. 1 month after having started I had another liver biopsy (because it’s where my cancer is now) which was by far the most difficult part. Also I had to stay 8 hours 3 times at the hospital to have blood being drawn every specific times. After 2 months I had another eyes exam/echocardiogram and CT scan. Labs are every month also ECGs. After 6 months of being on the study CT scans are every 3 months also echocardiogram.
The first 3 months were for sure overwhelming. I spent so much time at the cancer institute I felt my whole life was just about my cancer. Today, because the treatments have been working I think it was worth all the efforts. Also I appreciate the idea to be part of the research for MBC.
However if the treatments would not have been working I think I would have been very frustrated and disappointed on top of being exhausted (all the procedures are tiring).
Whatever decision you will make I wish you success with your next line of treatment.
You are very lucky to be included in this trial. I read somewhere that this drug Capivasertib works for many who have MBC. May it work for you. I think that it in the UK it has already been submitted to the medical regulatory board. Hoping that it will be approved soon and be available commercially.
Although the clinical trial is conducted in Singapore, I’m sure they have to comply with the international rules.
If your physician think you may qualify to enroll, you probably were given Informed Consent Form. It explains in a very simple language details about the trial, potential side effects, what type and frequency of the tests, etc.
Pls read it carefully and take your time.
Additional questions I suggest asking is how many patients already participated in this trial and whether any serious side effects were detected.
At the end of the day is completely your decision as it’ll require a lot from you.
Given that this is Ph1, the main objective is safety, not efficacy.
But that doesn’t mean that it won’t be efficacious.
thanks for your advice. Yes I was given a consent form. They are just recruiting participants and yes the clinical trial is global so no one has been given drugs until the slots are filled.
I understand your apprehension. Yes, there is a lot of testing and you feel like your life isn’t your own. I am in a clinical trial now, and all I can say, is that I am weathering the experience and the drug combo is holding my disease stable. I know you will make the right decision for you. Does your oncologist offer a standard treatment in case you decide not to do the trial?
I am currently on Afinitor and Aromasin but I won’t know if they are working until after my tests on 27 Feb. If they are not working my next treatment will be Piqray which is similar to the drug which is being offered in the clinical trial.
I'm on a Phase 3 Clinical Trial AZD9833 - I take Ibrance and either that trial drug or anastrazole - so regardless i'm getting treatment - along with the Ibrance I take 2 pills and one is a placebo and the other is either the anastrazole or trial. I did have to do ALLLLLL those tests leading up and it felt like a lot but i knew it was short lived, and I live 5 minutes from my oncologist office.
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