Clinical Trial Dilemma (HER2+++)

scrunchthecat

The NIH called last week to see if I was interested in a cancer vaccine trial for HER2+++ Stage IV. Some of you know that *this is exactly what I have been looking for* for about four months now. I rushed to send my materials to them (materials that are probably still on the ground in Florida thanks to the snowstorms up north), but then I learned a few facts about the trial that, should they accept me, I would have to think about. If anyone here has any experiences, thoughts or suggestions on how to handle these issues, I would greatly appreciate it!

* FIrst, the trial consists of about 5 vaccines, given over the course of about six months. The full length of the study is 2.5 years, however, because they follow up for two years. Here's the rub: I have to discontinue Herceptin and Perjeta while I am on the trial. The good news is that I can leave the trial at any time, or I might be thrown out of the trial for various reasons, and could then resume H&P. The bad news is: my onc says that Perjeta is only covered by my insurance company as a first-line treatment. If I go off of it for a while, they may not pay for it when/if I want to go back on. This is a dilemma for me, because I am doing well on H&P. According to the median results of the CLEOPATRA trial, I should get 2+ years of progression-free survival on H&P. I have only been on treatment for 7 months. I really want to run back to the warm embrace of H&P if/when the trial ends for me. Has anyone else had this problem? I would really like to make an arrangement with my insurance company before (if) I start this trial - making the case that they may not have to pay my bills for up to 2.5 years if they let me come back to Perjeta. Is this ever done? Could I defer the start date of the trial for several months? I would appreciate any advice.

* Second, this is a Phase I, Part 2 trial. They are looking for safety and dosage limits. There was a Phase I, Part 1 trial that is almost over (they recruited HER2+ tumors in cancers other than breast cancer). I think the preliminary results are here. Theoretically, I could beg them to let me take part in the Phase II trial, which I guess will begin in 2018. That trial will be more about effectiveness of treatment. But I have heard from several sources, including my friend at the German clinic, that it is better to get these vaccines when your tumor burden is lower, and as of October there is evidence that my tumor burden is low. Who knows what it will be 2 years from now.

* Third, I am trying to visualize what would happen to me at the end of the trial. In the best of all possible worlds, the vaccine would teach my immune system to kill HER2+++ cells. (It uses "polyclonal vaccine induced antibodies"), and I might not need H&P. In a less-perfect world, it might suppress some tumor growth, but not all, or it might flip some of my HER2 to ER+ or triple-negative. If I am cancer-free at the end of the trial, I think I would look for more options from my oncologist, such as the possibility of blasting my original breast tumor with radiation.

The trial is NCT01730118. If I am accepted and decide to join, I'll post the play-by-plays here.

sj

Hernie

https://clinicaltrials.gov/ct2/show/study/NCT01730118?term=NCT01730118&rank=1&show_desc=Y#desc

scrunch, it is great that you found a trial in the US. I read the detailed description.

They will remove your dendritic cells, infect the cells with a virus carrying the HER2 gene, and give them back to you. The idea is that the virus will produce HER2 in the cells, which will process and present HER2 to the immune system, which may then produce its own antibodies to HER2.

Remember that HER2 is also expressed on heart muscle. We already have some who have heart issues on Herceptin. That we can stop giving. This treatment will have the risk of your own immune system attacking your heart.

The goal of this trial is to see whether it indeed induces the antibody and if and how much heart damage results. If it is considered safe, then they will proceed to test if it improves survival, but right now it is to look at safety.

This trial is great for all the rest of us, but talk to the trial doctor in depth about risks and benefits FOR YOU.

Macy187833

scrunchthecat, thank you for the heads-up about this trial. I am just starting to investigate the possibility of clinical trials and I know next to nothing about them. Did you sign up to be contacted for the trial? How did the NIH know to contact you? I'm just lost when it comes to finding out about trials. Any information you wish to share, I would so appreciate!

As for Perjeta and insurance, I would definitely contact them and explain your situation. They might be able to make an exception or other arrangements for you to continue with Perjeta at a later date. Another option would be getting financial assistance from Genentech, the manufacturer of Perjeta if your insurance will not cover it again (and same thing with Herceptin). I haven't had to investigate assistance from the drug manufacturers so I can't give first-hand experience but hopefully someone else will chime in soon!

Good luck with making the best decision for you!

susan_02143

How can all of you be so sure that anyone's insurance company and/or plan won't change in the next 3 yrs? In the past three years, I have had three different policies. Employers seem to change providers yearly, going with the lowest priced option. I would not trust that the insurance company you have an "agreement" with would still be your provider, or they might not offer the same plan. On the same note, Perjeta might have different protocols, etc. by the time a 2.5 year trial is over.

Good luck weighing the pros and cons of participation in this study. Rather exciting to be thinking about a 2.5 yr trial! I don't have the guts to plan that far out these days.

*susan*

scrunchthecat

Thanks, everyone, for the responses. Macy - I did a search for HER2+ vaccine clinical trials. Information about Phase I, Part 1 of this trial came up, I contacted them (I think in November), and they contacted me last week when Phase 2 for HER2+ opened up. I have already sent them my material, so if they call me up for the pre-screening tests, I will go and have a deep conversation with the doctor who runs the trial. Right now my biggest issues are: 1. I don't really want to give up H&P, a known effective therapy, this early in the game; and 2. I don't really want to worry about my immune system attacking my heart, as Split-Bean points out. I may beg them to consider me for Phase 2 of their trial.

I called my friend at the German clinic and asked him about this. He said that it did not make sense for me to give up H&P for an experimental treatment. He also said that the dendritic vaccines, which is what this trial is about, are less effective than the peptide vaccines, which they can offer me in Germany. For $50k. I am going to research this claim further, but I am happy to have the German option in my back pocket, even if it would mean raiding my retirement account to pay for it.

Fitztwins

just to add it, I am doing prejeta not as a first line treatment...I started it last year. I had no problem getting insurance to approve it.

pwilmarth

I think that it's awesome that you were offered this clinical trial. I know that it's a difficult decision to make. It bears doing further research on the insurance side of things. There are laws in place regarding what the insurance companies can and cannot do when you elect a clinical trial.

Personally, I know what I would do but I don't think I would want to give you advice without all of the questions answered.

RonnieKay

Scrunch...I remember your legwork in looking for a trial, but I've forgotten what led to it (chemo brain, trying to keep dxs straight, etc).  Does your onc offer any type of guidance?  I talked to mine about concern on the blog about available trials & he reassured me that there would be one available if needed. He said pharmaceutical companies will always have something in the works. Then he invited DH & me to the open house at his lab at Fred Hutchison cancer institute.  He said 65% of his time is spent in research & he's been doing research for 25 years...although he looks 40!  He shared the 40,000 mbc losses every year for 30 years with the room...shock...except to me.  He said it's unacceptable & even though there've been great advances in tx...it's not enough.  Hope whatever you decide, it's the answer to living a long, long wonderful life....I'll even say cancer free!!!

Almosthere

Scrunch, what a hard decision! To stop HP, a known combo that can give us more years, for a vaccine that could offer a cure or some unknown outcome as a phase 1 trial would be brave. I understand it is best now instead of waiting for progression but I would be scared for you.

I would consider it only if I was NED for years and could risk stopping HP. I am just too scared and would only join a phase 1 trial if everything else was failing...

Almosthere

Plus there will be so many more treatments for us if we need them in the future. I'm interested in Margetuximab and how it will benefit treatment of HER2+ BC..

scrunchthecat

Hey bstein!

I have also been following margetuximab... named after Marge Simpson! (Or not, but now everytime I see it mentioned I think of Marge Simpson.) My oncologist suggested that I see if I can negotiate to stay on H&P. He said there are other ways to measure the vaccine's effectiveness. At any rate, if they choose me I am going to go up and talk to them. I have found that the more knowledgeable people I speak to about my condition, the better informed my decision-making can be.

scrunchthecat

UPDATE!

I heard from the NIH today. They received all of my materials and confirmed that I was HER2+++++. They still require that their subjects stop taking H&P when they start the study. Since I am still having a good response to H&P, they said to call them when (if) my tumor markers go up and/or we see progression on a scan. They said I should call them when this happens, and they will immediately let me into the study.

So hooray, I guess. I have an extra line of treatment when (if) H&P fail, and before Kadcyla. Here's hoping I never have to use it!