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

[Dianaq]

Actually my oncologist did not recomend this trial. I am with Kaiser, so they cannot recommend something that doe's not have enough data. But since I have been reading about it on line and asked about it, they told me that they have 3 trials going on right now.

[Lala]

Natalie,

I hope that my experience can shed some light for you. When I was diagnosed I had the option of two very different paths of treatment; the first was Herceptin and Chemotherapy, the second was a Clinical Trial of Monoclonal drugs with no chemotherapy. The thought really over whelmed me, with the help of an oncologist I learned to look at my treatment options in a totally new light. This simple analogy helped me and my husband to finally understand; Imagine a tree with branches, each branch represents a drug choice for treatment. The more branches you have in your tree the better it is for you, if a branch should break then you jump to a new branch. As simplistic as the above analogy sounds it has helped me explain to many why I chose the clinical trial.

There are so many factors that make up a trial. Here are a few questions I asked: What phase it is in, is it an open or blind study, what are the requirements you must meet in order to participate, how will I be monitored, how many are enrolled, is there any new data from the trial from those already participating? I also researched the trial drug.

I can tell you I chose an open trial and felt comfortable with my decision. I was monitored weekly with physical exams, blood and urine tests. I was scanned every 8 weeks to insure that I was responding to the drugs. I also had the option to leave the trial at any point.

In my opinion clinical trials can offer the best in health care. It was a great experience for me. I am thankful that I had this option and I am proud to have helped in the research of a new drug for breast cancer.


Best of Luck to you,

[AlaskaAngel]

I am NED. I have been in one clinical trial for 4 years, completed another one 2 years ago, and just started another one last year, plus have donated a blood sample for a blood pool of people who have had cancer that is used by various major institutions across the country.

For he clinical trials I participated in, only one involved taking any kind of drug and I knew it was potentially hazardous to my status of being NED.

So far, all of the clinical trials I have participated in have been NIH trials and not run by lesser-known organizations that might be more likely to cut corners with either the basis or the conduct of the trial.

The clinical trial coordinators were very straightforward and helpful to me as I pursued participating. One nice thing is that you can make the inquiry without obligation to participate, and ask all the questions you like without having to commit to doing the trial.

I continue to watch for more opportunities to contribute to documenting a rational basis for better treatment. Because of that, I am especially disappointed that researchers actively prevented me from having reasonable information about options for treatment with Herceptin for my own diagnosis. (I am part of what I call The Lost Regiment of HER2's, who were not eligible for the clinical trial but considered at high enough risk to endure chemotherapy, radiation, and hormonal therapy...!)

I also hope your oncologist was more helpful than mine. At time of diagnosis I was clueless about how to look into clinical trials and made the assumption that my oncologist could help me when I said that I wanted to participate in a clinical trial. Perhaps he was very tired or burned out when he responded, and limited the discussion by dismissing me with "There are thousands of clinical trials." I did not know of sites like this one at the time, or of anyone who was a participant in a clinical trial. Eventually I stumbled around and found the clinicaltrials.gov website and took it from there on my own...

Best of luck with your decision,

AlaskaAngel

[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!

[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

[doh2pa]

Hi SkiBunny,

Sorry, I haven't checked the site in a bit. My dad passed away suddenly last week and I have been consumed with that.

I was in the Telemorase Reverse Transcriptase Phase I vaccine with Dr. Susan Domchek at U of P. I was in from May until August when I advanced. I was still taking Herceptin and Faslodex at the same time. I thought I got great care there and when my disease advanced, I was able to use Dr. Domchek for a second opinion (she's great!).

I too asked about the autoimmune repurcussions of vaccine trials. I was told that there had been no data showing this to be a risk factor. Because I was not on a HER2 vaccine, there were no heart risks, but I am sure they will monitor you carefully with MUGAs or ECHOs.

What about you, what trial are you in??

Donna

[skibunny]

Dear Donna,

Thank you for responding. I am sorry about your dad. The trial I am in is called "Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast". It can be located under ClinicalTrials.gov Identifier NCT00107211

I was diagnosed with DCIS 12/03, had a lumpectomy 1/16/04 a relumpectomy 2/3/04 a sentinal node biopsy 2/24/04 and radiation 3/04-5/04. Since my cancer was non invasive and node negative, I was not given chemotherapy. Since I am ER- and PR- I was not a candidate for Tamoxifin or Arimidex.The DCIS has recurred in the same spot two years after I finished radiation. I am HER2+ grade 3+ and this vaccine trial builds antibodies against the HER2 overexpression which is fueling my cancer.

Monday, 9/25/06, I went for leukapheresis where they removed white cells so they could make the vaccine. Tomorrow I will receive the first of 4 doses of the vaccine, once a week for 4 weeks. At the end of the trial I will have a double mastectomy with reconstruction. The vaccine is added protection if it creates antibodies like it should. I do not want this to recur again.

Since HER2 is on normal cells as well as cancer ones, there is the possibility the antibodies created by the vaccine could attack normal cells (including heart tissue) and create an auto immune disease. So far that has not happened with any one who is on this trial.

You live close by to me. You can email me at CAGrabbit@aol.com if you would like to talk.

Sincerely,

Skibunny

[Alberta]

I am new here and am not sure exactly how to navigate the board, so please bear with me.
I am an 80 year old mom with a daughter newly diagnosed with mets. This is from a invasive ductal, node negative, her2neu overexpressed breast cancer.
It was first discovered April 2003. She had a lumpectomy followed by chemo and radiation to the area.
The first scan showed mets to the pelvis and a chest wall lymph node lighting up. She has since gone to MD Anderson and had repeat testing and scans. Those results not back yet.
She is planning to do a clinical trial phase 1-2 with several chemotherapy agents followed by a vaccine for the CEA markers that were elevated right before the clinical evidence of disease was found. I believe CEA125 and some others are included. This trial is being conducted at NIH in Bethesda, Maryland.
This trial tries to lower the immune response of the patient, before giving all the vaccine injections
Some of her white cells will be removed before chemo and then given back to her during the treatment process. She asked what I thought, but I could see she was determined to proceed matter my opinion.
As fast as her cancer returned she is worried that she needs to do this to survive any length of time.
So that process is starting as I write and she hopes to get accepted. This is for newly diagnosed mets that have not as yet been treated. Her2neu+++ and her2 neg accepted.
alberta