Are you currently (or have you been) in a Clinical Trial?
Comments
-
I'm starting cycle 6 on BYLIEVE clinical trial- alpelisib (300 mg) with Faslodex. I have an acquired P13KA mutation post Taxol. I find with Faslodex it needs to be administered slowly (over a minute per shot) and then rub the injection spots really hard to spread it out. Walking helps too.
Alpelisb SE are challenging, many, varied and not all that predictable....it's not an easy drug. I'm very interested in other clinical trials targeting mutations b/c I think that unlocking the tumour mutations puzzle will provide us with another tool.
Be well,
0 -
Pots, the trial I am joining has four arms for four types or subtypes of cancer. What they have in common is the ERBB2 or related mutation. I hope for both of us that this gene-directed therapy is our key to success!
Bev, the plan of walk then ice makes sense. We have to get the syrup to disperse before we ice, right? I will see about getting some ice packs for the ride home.
0 -
Oh, EV, I see that SoC must mean standard of care. In that case, does the trial give you the option of adding the experimental drug if you progress on just Taxol?
0 -
Greetings fellow warriors!
Question - I keep an eye on clinical trials, right now holding on Halaven. I know I am PD-1 negative but had not heard this meant I am not eligible for immunotherapy and didn't notice it among the trial exclusion criteria. So this is standard criterion for immunotherapy? Just looking for more info....thanks
0 -
Just gave a partial answer on the liver mets thread to this question. Can someone with more knowledge weigh in as well?
0 -
Shetland- I also got a bit nauseated from the Faslodex and learned to bring ginger chews with me or candied ginger and have a piece or two before the injections and ginger tea after them. I had lots of different nurses give me the injections and some were better than others. I got a weird local reaction twice in 18 months, both by the same nurse! the 3rd time she came in, I told her about them and she got another nurse to give them to me. it was an itchy large purple rash than took a week to resolve. I did do stair climbing and a walk afterwards. some of the nurses massaged them in, others didn't so I did it myself. my worry if I ever go back to the shots is that they are already considering underdosing (hence the hope for the oral SERD ) and if all the drug doesn't get into the muscle- more underdosing. otherwise- one fewer pill to take and refill-
Good luck
0 -
Diane, I don't know a whole lot about it, but I think PD1/PDL1, microsatellite instability, and maybe high mutational burden indicate that immunotherapy is more likely to work. I think they are working on drugs to make immunotherapy work better in cancers that don't have these characteristics. I think currently immunotherapy Is more successful for TNBC than for ER+ bc. Maybe use other therapies now and watch for a trial using a new drug along with immunotherapy? What does your onc say?
(Edit — Oh I see Bev said basically the same thing on the liver mets thread. )
I feel sick to my stomach today because I came across some research that indicated mutations related to the TORC pathway confer resistance to neratinib. One of those mutations, PIK3CA, does appear in my F1 report. So now I am afraid the neratinib trial will be a bust for me. I need the neratinib for sure to address the ERBB2 mutation, but I know no onc will let me have everolimus or alpelisib along with it for the PIK3CA because it has not been trialed. They are too damn conservative. The combo might hurt me? Yeah, well we know the cancer WILL hurt me.
0 -
Shetland pony- I hate news that screws up your days- but, I wanted to say that I think that breast cancer is just a crap shoot that is not understood and so individual. There are too many unknowns to make blanket statements unless is known to be true all the time. I was told that Afinitor would only work for 4 months after a CDK4/6 failure and I got 11 months. the news did ruin several days for me and didn't pan out.
I have a progression in my bones- my MO called to say that they are able to do a bone bx now that can check for mutations and hormone receptors - a technology that is brand new in the last week. she did not think that the foundation 1 in blood only was good enough. (?) She also wants to treat me with tamoxifen. not sure about that-
I heard that tamoxifen is inferior in lobular- she said no. she thought it was worth a try. thoughts anyone?
0 -
I’m going to be quite presumptuous and disagree with your onc on both counts, Nkb. Perhaps we should discuss more elsewhere so as not to derail this thread?
As far as my trial, since I can’t get what I want, I must take what I can get. Since I can’t get a PIK3 inhibitor along with my neratinib and faslodex, I will eat lots of foods that are purported to be natural PIK3 inhibitors and hope that will help. There is a trial at MD Anderson that has an arm combing neratinib and everolimus, but it is phase I, and I am not quite desperate enough to do a phase I.
0 -
Today I am doing six pre-trial tests: Echocardiogram, EKG, blood test, urine test, PET-CT and CT w contrast. Plan is to start trial next week.
0 -
Good luck, Shetland, with qualifying with the trial and with starting next week. Fingers crossed for you.
0 -
After failing on my Abraxane/Keytruda/Celebrex cocktail and being denied by insurance my next treatment of Abemaciclib + Exemesthane, I am hoping to get on the TROPICS 2 trial for Sacituzumab Govitecan. Shouldn't be a problem getting on the trial but then I might get randomized to the control arm. In which case, I will opt for Gemcitibine.
The whole appeals process took two weeks and now I have to do a two-week wash out since I was taking Exemesthane while waiting for the Abemaciclib authorization. In total, I will be off treatment for almost 4 weeks. Dealing with mouth sores since before Thanskgiving and coughing/shortness of breath for the last 3 weeks.
CVS Caremark is dangerously bad and I hope none of you have to deal with them. My health insurance company, BCBS of MA subcontracts them for specialty pharmacy (non-IV treatments).
Anyone else on this trial?
Hugs, Susan
0 -
SusaninSF,
I just looked up that trial. Is that immunotherapy? It looks interesting.
I guess I don't know how to read clinical trials summaries very well. When I looked at it, it showed two arms -- both with the trial drug. Is there always a control arm, as you described? I'm trying to figure these things out for when I have to go to my next drug, since I have many, many mutations in my cancer and those cases seem to work well with immunotherapy drugs.
Good luck on this trial and please keep us informed. Sorry about your troubles with your getting your drugs. Not what any of us needs to deal with.
0 -
SusaninSF -
I am in the trial and on the study drug IMMU-132. Have had 5 infusions with #6 on Monday. Please let know what you would like to know and I will share what I know.
Gumdoctor
0 -
Susan, I also have CVS Caremark. Among other shady practices, they force you to use their specialty pharmacies and push you into using their actual store pharmacies. The whole thing is a racket. Did they tell you why they denied your abemaciclib / exemestane? I ask because it may be an issue of your doctor's office submitting a poor certification letter or appeal. I requested and saw the appeal letter my hospital wrote when I was denied Ibrance / exemestane / Faslodex and almost fell off my chair. It said I was Stage 2 and had many other issues that automatically would disqualify me from the drug. Hospitals often or always describe patients by their initial stage in their records and I was originally Stage 2 (e.g., Stage 2 with metastatic disease to bone and liver). The social worker writing my appeal didn't consider that she might need to state that I have Stage 4 / metastatic disease in order to get a medication limited to Stage 4 patients or that I meet the basic qualifications/indications for which the drug was FDA approved. Anyway, I wrote the next appeal letter myself and the medication was quickly approved. I complained at the hospital as I found the work of this social worker very disturbing and the social worker was pulled from the appeals process permanently. Lord knows how many people were denied medications due to her incompetence and were never aware of it.
0 -
Another breakthrough immunotherapy step published in Science this week!!
Carl June, SuperHero, has shown that CRISPR-CAS9-edited T cells can be used in patients without catastrophic effects. Three patients, two with multiple myeloma and one with a sarcoma, also benefitted from the therapy but it was not curative. Multiple trials using newer technology are about to blast off, but this one shows its safe, obviously is a critical step.
https://www.wired.com/story/crisprd-cells-show-pro...
check out this fabulous Mr-Sandman-parody discussing all of this
0 -
JFL,
Smart of you to ask to read the letter. Will try that. I also spoke with CVS several times (several hours on the phone). They denied me because they wanted to force me to take Ribociclib. They must be getting some kind of kick back because Ribociclib and Abemaciclib are the same price. The logic in their denial letter didn't make any sense. On one hand, they were saying that Ibrance and Ribociclib were the "available formulary alternative" checkpoint inhibitors, not Abemaciclib. On the other hand, they said that there is no proof that getting on another checkpoint after failing on Ibrance would work. So why give me Ribociclib? Ibrance and Ribociclib are both CDK 4/6 inhibitors but Abemaciclib (Verzenio) inhibits 4/6 and 9. There is also a study showing that Abemaciclib crosses the blood brain barrier. Hopefully, I will get on the TROPICS 2 trial and not have to deal with CVS. Exactly the kind of thing they were hoping for. Now they won't have to cover anything.
BevJen,
Sacituzumab Govitecan is an Antibody Drug Conjugate. According to the literature, "Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate targeting Trop-2 expressing cells and selectively delivering SN-38, an active metabolite of irinotecan. " So basically a way to get a toxic payload to the cells that need to be treated, in my understanding. Have you been on Keytruda or Opdivo?
Gumdoctor,
Would love to know whatever you can tell me. Side effects? How well is it working? Thanks for replying!
Hugs to you all, Susan
0 -
SusaninSF,
Thanks for the info on the drug. No, I have not been on any immunotherapy at all, nor have I been in any clinical trials yet. Technically, I have been metastatic since 2006, when I had a single site metastasis to my cervix. Was put on letrozole at that time and that held me until 2019 when they discovered metastasis to my liver(and possibly bones). Now I'm on Ibrance and fulvestrant. Am really just gathering info for when these drugs crap out. My Foundation One report suggest that tecentriq (atezo) would be a good fit for me, but that's the only immunotherapy I've even thought about so far.
Good luck on getting your drugs, or in getting into the trial so you don't have to deal with the pharmacy.
0 -
Susan -
I was pulled off the study last week after 5 IMMU-132 infusions, due to liver progression and ascites development.
The main side effects I had while on it -
Severe fatigue, constipation, continued hair loss, severe skin rash on upper body (chest, back, arms), and continued neuropathy all fingers and all toes.
Several of these side effects started with Abraxane and continued on with IMMU-132.
I hope the best for you if you get on the study drug arm of the study.
As for me...I had a second liver biopsy last Thursday. Supposed to start Halaven tomorrow. I am unimaginably discouraged. There are not many options left for me and nothing is working. This is my own demon to live with and does not apply to anyone else...
Gumdoctor
0 -
https://community.breastcancer.org/forum/73/topics/860294?page=61#post_5515696
Susan, there was a post here about legislation to make insurance companies allow cancer patients to have the drug their doctor recommends, rather than forcing them to fail “similar” drugs first.
Gumdoctor, will they test that biopsy tissue to get treatment and trial ideas? I hate that you are in this discouraging place where things are not working.
I am on Day 5 of the SUMMIT trial. Neratinib, herceptin, and faslodex. The diarrhea is impressive, even on six Imodium per day. I am hardly eating anything. Supposedly the body eventually adjusts.
0 -
Gumdoctor, sending you warm hugs. I hope you are able to get some mutation testing done on your sample.
0 -
Gumdoctor,
So sorry to hear about your terrible side effects. Have you tried Xeloda? That was one of my favorites. Had some sensitivity in my hands and feet but was able to alleviate most of it using Heel Balm. Especially nice since it's an oral medication. Aromasin+Affinator?
Were you on antihistamines? I had a terrible skin rash after getting off of Piqray but a twice daily dosage of Zyrtec and some Triamcinolone cream got rid of it within a day. Have continued the double dosage of Zyrtec ever since. Abraxane was part of my last treatment. I iced my hands and feet during infusions. Bought two pairs of these: Cold Therapy Socks and used them on my hands and feet. The ones made for hands were gigantic, like catchers gloves. Daily oatmeal for breakfast keep me regular but that probably isn't enough for your condition.
To fight fatigue, I try to sleep for at least 10 hours a night. I have slept as long as 13 hours. Sounds crazy but when I sleep for that long, I don't feel so fatigued during the day. Do fairly strenuous exercise every day. Hard to fit all my med dosages into such a short day.
We are all so different so my many alleviation methods may not help but wanted to give you as much info as I can. I think you still have have many options and there are many new drugs in the pipeline.
Hugs, Susan
0 -
Thanks Shetland Pony! Will see if a similar law is being discussed in CA.
0 -
Susan -
I made a whole 10 days with Xeloda in July. Had some kind of toxic reaction that lead to liver infarctions. HFS was so severe on my feet that I could not walk for several days. Also developed a severe rash on my arms that looks better now but will be permanently scarred.
I can't say MO will say no to AC but I had FEC-T for stage 3 bilat BC so there are limits on what I can have.
MO started me with Abraxane + Carboplatin and removed Carbo on 2nd infusion because of infarcts...and blood clots...and neuropathy...
Gumdoctor
0 -
Hello to all. A very dear friend here has suggested I post my experiences with clinical trials. This is my first post but have been lurking for a couple years. I am amazed at the knowledge. I am not sure if my info has been done correctly, but if you have any questions feel free to ask.
After having a dx of mets to lung in early 2019 I decided to go to Princess Margaret in Toronto. I knew I didnt want to do chemo after chemo. I have done 3 clinical trials since then and have entered my fourth last week. The first 2 were unsuccessful but the 3rd I had great results. This was the same trial as KattySmith. (Bms986310) an ep4 inhibitor and nivolumab. My first scan showed 60% decrease. Unfortunately I had progression in the form of a brain met. I had never scanned my brain prior. (It could have been there all along) an ammendment to the trial has included possible brain swelling and I wonder if that was the issue. I had brain radiation in Nov and have had a good response. All other mets have been stable since October until now. So now onto the next trial. This trial is int230-6. Keytruda with an injection of chemo and a nanoparticle thing. Lol. I had my first injection last week. I was warned it would be painful and it was. Will it stop me from doing it again, probably not. I know there were 6 cohorts to this trial and I am in part 5. This was the addition of keytruda. Apparently the trial has had good results with just the injection with breast cancer. They feel adding keytruda will get better results. I will post again with updates as this trial continues.
Kathy xo
Yep didnt figure out how to add info, will try again. Here's in a nutshell.
I am triple negative with mets to lung liver, brain, axillary lymph nodes chest wall and 1 bone met.
0 -
Hi all. I read posts here, but I am not on a clinical trial (yet, who knows my future). I live in a rural area and receive my care at my local onc office. Ok for now. But depending on how my progression looks when the time comes, I may travel to a larger cancer facility that offers clinical trials -- 2 hour drive from home.
I have a question for this group- Does insurance cover clinical trials? I know it depends on the insurance and the trial. The reason I ask, I was at my MO office yesterday and was talking to a staff member about wishing we offered clinical trials. She agreed that would be nice for the patients, but then she said "Most insurance doesn't cover trials, though". Is this correct?
When progression occurs, I will do more research. But just thought this Thread would have some answers to the insurance question.
0 -
Candy,
We just talked about this the other night at my metastatic breast cancer group. The trial offers the drug(s) usually for free. But normal stuff like blood work, scans, etc. are run through insurance. I'm not sure if ALL insurances will cover, so I think you have to have it checked by your MO or by you first.
Hope someone else can add more.
0 -
Candy, as BevJen said, the trial drugs are covered by the trial and the scans and bloodwork are run through a patient’s insurance. In most cases, there should not be a gap for an insured patient. When I was in a trial, my insurance company actually permitted me to have PET scans every 2 months per the trial protocol.
0 -
different trials also have different amounts of funding. This is why sone services go through insurance. I just began a trial in December and am a little surprised at how expensive it actually is for me. I do get access to the drug I need so it is worth it.
And be prepared to decide how far you will go for a trial and what type of trial you are willing to participate in.
I would not participate in a trial where I did not receive the drug being studied and I fly to another Tate to participate. All worth it in my mind.
You will have to make sone choices should you go the trial route.
Good luc
0 -
I am not ready for a trial yet---stable on ibrance/Letrozole/Lupron/Xgeva combo, first line therapy.
I was just wondering about insurance/cost to the patient for a trial. The staff member of my cancer clinic said that insurance doesn't cover trials. And she seemed to act like if we offered trials at my local clinic the patients wouldn't take advantage of the trials because the majority wouldn't be able to afford to pay out of pocket. So offering clinical trials to their patients doesn't seem to be on their radar. I don't know all the hoops the clinic would have to jump thru to be able to offer trials in my area.
I don't know if trials will be in my future. I don't want to exclude any option that may help me. But also, another question for the group--- if I enroll in a trial 2 hours away from my home, do I have to go to that facility for blood draws and scans? I would think so. So then multiple trips for blood draws, scans, doc visits, etc. Could add up to a lot of travel time and travel expense.
Leftfoot- You said you are surprised how much expense it is for you. ??
My insurance is billed for my blood work and scans now, so if they were billed for blood work and scans on a trial then it would be the same. Right? So med thru trial company and testing with insurance like now?
Also, Yes I would want to be assured I was on the medicine, not the placebo group.
A lot to learn.
0
