HER2 Breast Cancer Trials

[al from Canada]

but and as I posted before, I have the utmost respect for researchers and I know they don't do this for the money, or lack there-of. However, the fact remains that they do have trouble recruiting and it is the FDA that has tied everyone's hands in trerms of approval process and design protocal. I'm aware of the stats ie 1:8, and am appauled that the FDA isn't reacting faster in fast tracking some of these outstanding programmes to bring this epidemic to an end. What do we need, 1 in 4? Watch how fast vaccines get approval for a non-existing but predicted flu pandemic, where the mortality rate will probably be less than what we are taliking about. Sorry, I'm getting bitter and twisted now so.....
Signing off with love,
Al

[Ginagce]

Thanks Joe. Very good information.

Ginagce

[TriciaK]

Thanks, Joe! I am astounded by the number of trials listed here! I agree with StephN: this list needs to be "stickied" and added to as new ones come up. I also understand all the frustration you are expressing. For instance, I seriously doubt if I will ever be able to take part in any trial at my age, yet I wish someone would be willing to study women like me who have survived 20 years with no chemo or radiation until these last mets. I have actually had only surgery for the initial BC (March, 1985), only tamoxifen for the vertebra mets 5 years later (June 1990), and for the last mets 15 years later ( June 2004) only 6 months of navelbine, plus continuing herceptin and femara. NED for the last couple of months, off herceptin last 2 months because of low MUGA and echo, now on only femara. It will be interesting (at least!) to see how long I can stay NED on just femara and whether my heart will heal enough to be able to have herceptin again if I do need it. Anyway, I hope and pray that the trials will be available to all the courageous women on this website who desperately need more miracles. This website and information like this list plus all the other info, experience, love and williness to share is phenominal. I can't tell you how much I admire, appreciate and respect you! Hugs, Tricia

[al from Canada]

Hi Tricia,

It's so great to hear from you on a regular basis.
I agree with you 100% but wonder if your situation can't be resolved with a fearless onc. I personally feel that they should open many of these investigational drugs to any re-occurring stage 4's. Or, how about a policy statement for stage 4's who don't qualify for trials. It takes some courage on the part of the FDA but it is required as endorsement for insurance coverages. To be honest, I just don't get it! I am running into the same situation with Linda. Here's a case where a drug is approved for colerectal cancer (avastin), which would more than likely help my wife profoundly but because she has BC, the hospitals won't get funding from the province soooo... we have to find the $50,000 + per year. Let's call it "the last horrah act".

Still bitter and twisted but appreciatively yours,
Al

[Lolly]

Al, I tend to agree with you, and although I haven't gotten to the bitter stage yet, I'm definitely twisted and bent! Out of all the trials listed, I found two I MIGHT qualify for. Discouraging. But, we have our champions at UW/Seattle working diligently to design trials to include as many of us HER2/Stage IVer's as possible.

<3 Lolly

[al from Canada]

I REST MY CASE

al

[AlaskaAngel]

Steph,

Al's point (that so many trials exclude those with prior Herceptin history) is a major reason why I have trouble with deciding to start Herceptin now, given that I am currently NED. I don't know if the researchers or the companies behind the clinical trials understand how awkward or difficult or cumbersome the clinical trial idea can be for potential participants. Although I have participated in 2 clinical trials thus far and have been a strong advocate for everyone to do what they can to be "part of the solution" to all of the questions about cancer, if the researchers and companies don't see the problem for those of us who are most likely to be interested then I have to question how successful they will be in finding participants as time goes by.

I am probably at less risk than others since I am HER2+++, ER+ and PR+, but even at some risk due to delay I would rather use my situation very carefully to try to add to the knowledge base by documenting the result in some way rather than go off-label. I just hope the researchers and companies see who is out here and make more of an effort to match up with us.

A.A.

[StephN]

... that we here are real flesh and blood patients (and caregivers) who are fighting for our lives NOW. Look at my situation - ALL of my treatments have been clinical trials starting in 2000 with my adjuvent Adriamycin on weekly doses with Neupogen support. I have to exclude my Gamma Knife, though, so am speaking about my various chemos. What is now known about why these adjuvent treatments did not work for me has added to the knowledge base. And I am very thankful that one of the trial drug combos finally DID work for me. I know this could change any day, but that is not my first thought every morning!

My med onc is a BIG fan of clinical trials and brought up the subject of the vaccine trials when I was first diagnosed in 2000. Unfortunately I have not yet been able to qualify, though I think the last barrier has been removed lately so that there is one I could go on.

My comment above in this thread about how many new breast cancer patients there are as potential trial candidates came from something I heard in a conversation with some high-powered researchers at the San Antonio Symposium. It is like they want to use patients as they do the mice (or virgin maidens) and don't want our various case individualities or histories to complicate the trials any more than they already are. And this was not in any reference to the FDA. They need to establish baselines and choose pathways from which to work. Unfortunatly this excludes many people who may benefit now from that therapy.

Sad, but true - how do we break through this? The only way right now is if we can't qualify for a trial we have to go off label with some new drugs if the old ones that are approved are not working. Or wait for new ones to be approved or new trials to become available. And there are tons of trials, but for those of us who are a long way down the cancer road the options decrease as we go, but then suddenly a new direction may open up.
YEAH - something to get bent and bitter about, as we try SO hard to find a way to live a reasonable life with a harsh and chronic disease.
Just remember the squeaking wheel gets the grease! Yell and scream if you have to.

A.A. - if you look at the abstracts from San Antonio you will see a whole lot of trials that INCLUDED Herceptin. The researchers now know a lot more about who benefits from Herceptin and what kind of drugs are synergistic therewith. They know that if we are HER2+++ we NEED the Herceptin as well acting against the tumors to achieve good results. That much was quite evident in what I saw in the presentations and heard privately. AS well, some new trials that include Herceptin were announced.