How do I make a decision about entering trial?

[sabpri]

I just passed my one year anniversary from diagnosis with breast cancer (August 05). My diagnosis was at least Stage 3, and probably Stage 4 (inconlusive mets to bone). I am only 38 years old, with 3 young children that need me for a very long time. I want to do everything that I can to beat the odds.

My friend who has been battling mets to lungs for 3 years is currently in a clinical trial (stem cell transplant and vaccine + immune therapy). She told me she wished she would have been more aggressive about finding a clinical trial/vaccine trial when she was in remission, prior to her recurrance. Not that it may have been prevented, but maybe. I have blown it off because I didn't want to deal with any more treatments and try and put this behind me, as I will be coming off Herceptin in October when I hit my one year mark.

Lately I have been thinking about what I can do to better my odds. I have already had a double mastectomy and ovaries removed. I am taking Zometa for my bones and Arimidex, but I feel like I should do more instead of waiting around hoping and praying this beast does not come and get me again.

I guess I feel intidmidated by the thought of looking at clinical trials. I saw a thread about a new vaccine trial opening up in October, but where do I even start? How do I make a decision to move forward in participating, and how do I know which one is right for me?

Obviously I will consult with my Oncologist, but I know the ultimate decision is going to be mine.

Those of you that have done one, or are contemplating one, can you help me with what kinds of things I need to look for, what type of process you went through to make your decision and any other experience in taking that plunge to pursue additional avenues other than the "normal" treatments like Arimidex and Zometa.

Thanks so much!
Natalie

[Bev]

Hi Natalie.

This is a good question. I'm posting so this stays current on the board. I haven't done a trial yet. I guessing somewhere on this site there are links to trials. You could also just google breast cancer trials. The most exciting seem to be the HER vaccine in Seattle and DC area.

Best of luck. I know the others will respond soon. BB

[Lolly]

Natalie and Bev; here's a direct link to the page from this site with clinical trials links. Alternatively, you can click on "Home" above, then go to "Index", the "Clinical Trials".
http://www.her2support.org/a/newher2.htm

[doh2pa]

Hi Natalie,

You are very wise to be asking these questions. I think all of us here understand the pull to "get back to normal" and not have to have our disease front and center.

I have metastatic disease (originally diagnosed stage IIA two years ago) and finished up 6 months of chemo in March. I really do believe that clinical trials are important but you have to balance that with your life. I looked for a vaccine trial and there are many but I wasn't willing to upset my life (job, kids, husband) by flying out to Seattle (I live in PA). So I searched and found a vaccine trial close to home at University of Pennsylvania. It was a phase one, and I wasn't sure it would help me, but I thought the concept was so exciting and forward thinking that I wanted to be part of it. The trial was easy - I went in for a shot (4 shots actually) every 2 weeks for the first 4 treatments, then just once a month. The only reaction I had was some injection site discomfort (redness and swelling) but when you've been through chemo twice, it was a breeze.

Alas, I did advance and have begun more chemo (and hence got kicked out of the vaccine trial) but I am so glad that I did it, because that kind of relatively innocuous therapy is where we need to get too. I hope in 10 years, women will look back on chemotherapy like we look back on leeches and say "what were they thinking??".

So that's my 2 cents, if you can find one (look on the nci.gov web site) that's convenient and not too experimental, give it a whirl. You can always drop out if it's not right for you, you are in control.

Good luck in your search!
Donna

[Dianaq]

I am starting a Clinical Trial. All I can say is that you have to go with you gut feeling and try to feel good about it. I just kind of put my hands in God and try to keep my thoughts positive.

[Ceesun]

I began a clinical trial about 4 weeks ago. My oncologist suggested it and I thought it was a good idea. Remember you and the oncologist are in control. Follow up is quite good so if it is not helping, you can pull out at any time. The trial I am in t he drugs are all known so you know what you are getting rather than the placebo type. Good Luck to you Ceesun

[skibunny]

Dear Natalie,

I am considering a vaccine trial at U of Pennsylvania. Which trial were you in? I am so worried that the antibodies to HER2 will attack normal cells and cause an auto immune disease or heart problems. Do you know if this happened with anyone on your study?

Skibunny

[skibunny]

Dear doh2PA,

I sent this to Natalie by mistake. I wanted to ask you my questions.

I am considering a vaccine trial at the University of Pennsylvania. Which trial were you in. I am so worried that the antibodies to HER2 will attack normal cells and cause an auto immune disease or heart probles. Do you know if this happened with anyone on your study?

Thanks,

Skibunny

[marymary]

Dear Natalie:

I think this is the question that we all must answer in our own way and in our own time. I think you provided the answer in the last sentence of paragraph one. You said something like (sorry, it's not in front of me now) "I want to do everything I can to beat this."

I can empathize with what you must be going through, since I have travelled essentially the same road. In my case, however, I did not have three little girls at home. My son was a senior in high school at diagnosis. He still needed me badly, though. He is 22 now!

As I've mentioned here before, the doctors were not very optimistic in my case. They took this attitude to such extremes I didn't even know if I'd have a minute left to fight! I have had quite a few minutes. The minutes turned into months and by some miracle into years.

I came back fighting. Out with the ovaries, in with the Arimidex. At that time Arimidex was brand new. My Doctor said "do what you want". I networked, as you are doing and heard amazing things about Arimidex. Arimidex alone gave me several years.

When I recurred with 2 mets to brain I changed oncologists to gain access to Herceptin, which my former oncologist advised against. I had Gamma Knife. Herceptin + Arimidex still didn't make me feel safe and I began searching for trials. Sunday night I returned from Seattle having received the second vaccination out of a series of three. It's been a year and a half since my brain mets. My body still appears clear.

Weekly trips to UCSF helped emphasize the deadly seriousness of the foe. Over and over again this weekly pilgrimage proves to be a stiff innoculation against complacency. A newly made friend died. I too worry about auto-immune disease as well as heart toxicity, but I worry about HER 2 Neu positive breast cancer more.

HER 2 Neu is a clearly identified target. It is fueling your breast cancer. The Seattle group has not published their results yet, although I believe this is in the works. To advance to Phase II trials they were required to have documented success to receive NIH funding. It is my understanding that they provided this. These types of studies have been underway at the University of Washington for seven years.

This is how I decided to participate in the vaccine trial at U of WA. I too am afraid; I try and choose very thoughtfully what to be afraid of.

Mary

[Lee]

If there is a good chance you are stage IV, why are you stopping herceptin? I was diagnosed as stage IV last fall, and I'm currently in remission, but I am going to continue on the herceptin indefinitely to keep the mets at bay. I'm pretty sure this is standard protocol.

I would consider asking your onc if you can stay on the herceptin.

I don't have any advice about clinical trials, but good luck!