Number of HER2+'s 12+ months out

I may be beating this drum too often, but I do think this group of people may be large enough to be worth a clinical trial since the oncs clearly don't have a consensus (i.e., they just don't KNOW enough to say, and we are high and dry for some real answers).

Patients and oncs working in this category are going at it hit or miss and have to stumble around as best we can, and at the end of all this effort and expense there will be no data to learn from.

I believe there are years and years of currently NED HER2's who were treated with either CMF, CEF, CAF, or AC without getting Herceptin, and who would be willing to consider participating in a clinical trial where some would be treated with a taxane with Herceptin and some with just Herceptin. There are also years and years of those who didn't even know what HER2 was, and who might now be having their tumor samples retested; or like me, whose oncs never even told them they were actually tested and determined to be HER2 positive.

Keep in mind that it is possible and even likely that there are more individually targeted therapies coming our way "someday". It is also true that Herceptin doesn't work for everyone who happens to be HER2 positive.

So, how many of YOU would consider participating IF there was a clinical trial offered to determine whether Herceptin with a taxane vs without a taxane for a period of time for those of us who are HER2 positive and NED? Do you have any other thoughts to add?

AlaskaAngel

[michele u]

are you wanting to include people that have already done the herceptin adjuvant trial and wanting to take herceptin and taxol together now, if we didn't get that arm? I'm not sure what your wanting. I got herceptin after taxol and i asked my dr it would be nice if i could get herceptin with taxol now due to it being better and he said no.

Hi Michele,

Once again oncologists are not clear on what is "best" for any of us, and that leaves us trying to figure out whose advice will give us the most protection when there is no best answer -- and yet oncs are all coming up with various answers anyhow.

I want to know from EVIDENCE more about the choice of taking Herceptin WITH the taxane, or the Herceptin alone, and just how much each choice ends up dropping the recurrence rate or not as the years go by, or even just how much side effect there actually truly is, rather than just go by their best "guesses" about side effect. Do we even know for sure what the recurrence rate truly is for those 12+ months out, since there are so many who do not even know their HER2 status?

So I would think that in a clinical trial some would fit into your category too. Or am I not understanding your question?

Basically I think it would be helpful to simply get some idea whether the group of those who are interested in getting genuine data from a clinical trial is big or little.

A.A.

Since I am proudly among the Her2+ & NED (again), I have to be very honest and say there's no way I'd volunteer to go back ON chemo again WHILE I'm NED.
Knowing my strong Her2 status, I have to be prepared to go back on chemo again, if & when I need it, the very moment I need it again, but not a second sooner. Aren't we always told to save chemo for when you must & take breaks when you can, if you can. I'm also always a bit nervous about developing a resistance to chemo & I'd just as well not expose my body or any of those microscopic cells that might be floating around, giving them a chance to morph into something resistant to tx.
I'm inclined to think that most oncs out there (& the FDA) would be extremely hesitant to recommend that women expose themselves to the toxicity of chemotherapy if there's No Evidence of Disease in their body.
Oh, one last thought...the cost of a research is astronomical!Unless there's enough preliminary evidence (via retrospective study of data from previous clinical trials), indicating the results of the trial will fall in favor of the pharma co, revealing a new, substantial population of cosumers paying $$$ for their drug, the pharma co. isn't going to be too quick to sponsor such a trial.
We're still in the beginning stages of figuring out if any of that data from the first adjuvant Her2 trials can point researchers in the right direction. I believe they'll come thru with something we can sink our teeth into very soon.

I had Herceptin about 24 months ago both with chemo carboplatin/taxotere and alone. My cancer still grew so I was taken off Herceptin. After this round of Abraxane I may ask for it again in hopes that Avastin will soon be approved.

Does anyone know why the "six months out of chemotherapy" was chosen as the cut off point? Was this tested in the trials and shown to be beneficial?

Just wondering.

Thanks in advance and best regards,

Becky

I know Alaska Angel from my attempts to try to get something like this going. It is taking me a while to navigate this information and I am new to these message boards or whatever they're called. And I never thought of myself as a techonerd!

I would certainly volunteer for a trial for herceptin in this scenario. I'd even consider herceptin and chemo.

I am 2 1/2 years after chemo, ER and PR negative and this is the only straw I have.

I have heard of a oncologist who is interested in such a trial, but he also has advised he can't get the funding.

I am not surprised. The pharmaceutical companies are unlikely to be interested in a trial on a group whose number is declining. Let's face it as the clock ticks so does the likelihood of us developing mets and then we'll get it anyway. And there are no new members of the club as newly diagnosed patients will get it.

Has anyone every tried lobbying Genentech?

[AlaskaAngel]

I realize that it is the hormone receptor negative folks who benefit the most from the use of the taxanes (and so probably not ME), but I'm going to take a shot at asking the question again now that this group (including me) are becoming more and more educated about the ins and outs of treatment.

Wouldn't it make sense for those who finished treatment over a year ago, who:

1. were not allowed to be part of the Herceptin trial and who are having to go off-label to get Herceptin

2. who can't benefit from an AI or SERM and who are HER2+++

to be offered a brief run (like the Finnish trial) of Herceptin plus a taxane?

[PatS]

I am 3 yrs out from chemo (4 A/C followed by 4 taxotere) and would definitely be interested in herceptin but I'm not sure about adding chemo to it. I am currently waiting for my onc to find out if my ins. will cover herceptin this late and will then decide what to do. My onc is very reluctant to give it to me now but said she would if I absolutely needed it to be at peace.

Pat

(diag. 07/2002, stage 3, er/pr+, her2+++

[Barbara2]

But, I doubt very much that they would be willing to offer a trial that contains a taxane for the "late" HER2+ NED people, although they may consider offering Herceptin alone. I am getting late Herceptin now, and my onc is willing to give me taxol, but I haven't been brave enough to do it although something keeps nagging at me to go ahead and go for it.

I called the Mayo clinic in Rochester, Minnesota, to ask the doctor that I had seen for a second opinion when initially diagnosed with cancer, what she would advise in regards to adding the taxol to the herceptin. She said she would not do it, as there is no proof etc etc etc. And I've read on this board of other oncs who don't recommend adding it to late herceptin either.

I, too, have asked and asked and have tried to find trials for people in this catagory. I wonder if there are too few people who would qualify to take part in a trial of this sort. Plus, oncs seem reluctant to experiment with a chemo on NED patients.

Having said all of that, YES! I would love to take part in a NED trial. Anyone else??

[RobinP]

I have seen via of message boards and word of mouth, a number of people doing late herceptin. However, I have not found anyone who is doing it with chemotherapy or taxol. I think the general feeling is who wants to go through all that again when there is no proveth that Herceptin as a single agent is not as effective as with chemotherapy in the adjuvant setting. This is quite evident in the HERA trail where herceptin was given after chemo where the increased DFS was about the same as the NCI trails where Herceptin was given with chemotherapy. I also think a lot of women just don't want to go through chemotherpy again, loosing hair, feeling sick for weeks or months when they are NED and seemingly have no reason for it. I just don't see late herceptin trails with taxol as a happening thing; who would volunteer for it- not many.Also, doing more herceptin late is bad enough.Am I the only one feeling vulnerable and like a cancer patient all over again with the weekly or triweekly reminders of Herceptin?LOL.

Interesting thread AA, I wish some mets people here would contribute too on your inquiries about the efficacy of herceptin and taxol. Any takers???????????????

[amya]

I am 2 yrs. 3 m out from chemo. Stage IIB ER/PR -, HER+++. I was in control arm of study receiving AC/TX no herceptin. My onchologist agreed that #1 I was at very high risk of recurrance and would likely benefit from Herceptin and #2 it was highly unlikely for anyone to do a study because there is a discrete number of us in this category and our numbers will be decreasing. Originally my insurance company declined but I just got word yesterday that my appeal was accepted and they will now reverse decision.

I think that the deciding factors were the strong letter written by my oncologist and the poor prognosis of my pathology.

I believe it is unlikely for any trial with herceptin. Perhaps the path to take is to push the insurance companies that it would be more financially beneficial to them to give us the herceptin now rather than paying for the more costly option of treating a recurrance. Sadly I think that is the #1 concern of the pharmacueticals and insurance companies.