AE37 Vaccine Trial - for recently treated high-risk patients

TectonicShift

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fredntan

I love the way you explain things! I get my second injection tomorrow

Maggs09

In theory you are right! But in real life, apparently chemo, rads and hormonal therapy are not very successful at killing cancer stem cells, therefore some can survive and at some point "wake up". (I'm hoping Metformin will work to disable or at least weaken those). In addition, it has been proven that with time we become resistant to hormonal therapy, therefore people get recurrences.

So any "back up" treatment or vaccine that add some control over cancer has a huge significance.

TectonicShift

Yeah, I understand. You want every possible weapon. I just want to make sure you don't feel bad about not having any her2 receptors, if that's how it turns out. It you're her2 zero COUPLED WITH ER 100%, you're in the best situation possible for a stage 3c. The only thing better in terms of prognosis would be if you were grade 1 rather than grade 2. (Although grade 1 doesn't go to stage 3c all that often.)

Kay_G

I start this trial on Jan. 7.  Found out I am in the HLA positive group.  So I know if I were given a choice, I would have chosen to be HER2 negative and ER/PR positive if I had to have BC. Is it better to be HLA positive or negative?  Not that one can do anything about it, but just wondering if there is any significance.

TectonicShift

Hi, Kay. There are more vaccines in trials right now that work on HLA A2/A3 positive than A2/A3 negative. Actually AE37 is the only one I know of that works on HLA A2/A3 negative.

In addition to the GP2 Peptide Vaccine you may get in January, you can also look into the NeuVax vaccine (aka E75) which is for HLA A2/A3 positive only. That's already in phase III trials. 

I've seen a couple other vaccine trials for different vaccines that target HLA A2/A3. Most Americans are A2/A3 positive.

When these vaccines start to get approved (*fingers crossed*) you'll be in good shape. Maybe you can get all of them! 

Kay_G

Interesting. Thanks for the info. My onc asked me if they did echos every three months. I told him I didn't think so. I think he thought they were afraid of the same kind of heart damage herceptin can cause. My EF went down 20 points on herceptin and I got put on a beta blocker and ace inhibitor, but the research leader knows about it and said it wasn't a problem.

fredntan

Question for those of us on the trial. We get the two injections in leg. Does everyones injection sites get red and itchy? Mine get about size of fifty cent pieces. But I dont feel icky. I didnt feel ickywithneulasta either.



I am inthe armthat isnt the ae37

TectonicShift

mine get red, about the size of a quarter to a half dollar, but no itch at all. i'm in the ae37 arm but i'm pretty sure i'm in the control group

SpecialK

Kayg - I was HLA positive also - you will be sorted to the GP2 peptide arm.  The difference between the two, I believe, is that the AE37 vaccine works on lower expressing Her2 positivity.  There are no echos - that would be up to your personal MO to order if he/she thought it was appropriate.  This vaccine is an immune system stimulant and does not work the way Herceptin does - I don't believe there is cardiac risk involved.

fredntan - I got fairly large itchy spots - they got larger each time.  I only felt icky the evening of the injections, and not consistently icky, some times worse than others but never enough to stop me from doing anything.

danindenver

NeuVax Phase III Clinicals were given the FDA green light in Jan, 2012. Studies are well underway throughout the US and numerous other countries. I would call Galena Biopharma to inquire about eligibility but as i know it: Node pos; HER2 pos either 1+ or 2+ ER/PR either neg or pos. One injection per month for six months followed by a "booster" shot once every 6 months. Phase I and II clinicals demonstrated statistically significant results in helping to reduce recurrence rates. I apologize for my blatent "facts," but during my wife's battle with HER2 we stopped at nothing in our efforts to identify any promising leads. Wishing you only the best, dan.

fredntan

Neuvax iitially said I could do the vaccine, but was later disqualified due to 13 nodes positive. I was so disappointed when I found out I wasnt eligible

Maggs09

Fredntan, how is that 13 positive nodes disqualified you from participating in vaccine?

I thought that trial was opened to stages up to IIIc, as long as HER 2 is more then "0".

I'm sure, I've read several posts, here, on BCO, from girls with significant number of nodes (+), participating in the vaccine trial.



I'm confused....

SpecialK

maggs - the Neuvax trial is a different trial from the AE37/GP2 trial

Kay_G

I had neoadjuvant chemo, so don't know exactly how many nodes, but "multiple" nodes were involved, one being 2 cms.  I think Special K is correct.  Not sure what site might be convenient for you, but if you click on the link in the original post, it will give you the sites doing the trial and contact info.  If you're still withing six months since treatment ended, give them a call.  Good luck.

TectonicShift

The phase3 neuvax trial only allows up to 3 nodes (or maybe it's 4). You can be stage 3c by tumor size and be on the trial but you cannot be stage 3 by node number. Seems like kind of a cheat to me to get better trial results. Oh but for neuvax to work on you you also must be hla tissue type a2 or a3 positive.



The phase 2 ae37/gp2 trial allows any stage 2 or stage 3 (not sure about stage 1) but you must have at least a little her2. (Cannot be her2 zero)



Maggs did you get your new path report with new her2 number?



Btw there's another neuvax trial about to start giving both neuvax AND herceptin to low her2 patients. That's the one I wish I could be on. But i am hla type a2 negative and a3 negative so neuvax wouldn't work on me.

Maggs09

You, guys are so well informed with all those trials!



Tectonic, I'm still waiting. Before Xmas I got an email with an update. So, they've collected all the slides, images... from my main surgeries from end of June, but they were still waiting for slides from my initial lumpectomy done at local hospital. It looks like local hospital and dr (who screwed me totally) are not co-operating....

I guess they want to have everything from every dr and hospital that treated me, before providing a final report.



If I'm confirmed HER2 "0", then I'm happy because I will know that AE37 vaccine would not make any difference.

Tectonic, you are also taking Metformin, right? How are you taking it? What were initial SE?

I'm currently doing rads and 2 weeks ago started tamoxifen. My onc is fine with me adding Metformin, I just don't know if I should start it now or wait a bit longer. It's "off label", 850mg starting dose. Is it better to take it in the morning with Tamox or at different time?

Husband11

How long have they been measuring Her 2+1, 2 or 3? I've always heard that Her 2+ was based on a threshold, but can test from back 3 years ago reveal to what degree you were Her 2 positive or negative (as needed to know if you are Her2+1 for instance?)

fredntan

Hey tectonic, are there any other trials you think might be beneficial? I too will be starting metformin off label in a few days. I would think you would want to check your blood sugars from time to time. If you call the company that makes the strips they will send you free meter. There will also be coupon in endof jan paper for free one touch meters. You might also want to review low blood sugar symptoms-dizzyness, confusion, tiredness. Andcarry fast acting sugar for lowes until you get used to it.

TectonicShift

Timothy, I've had three path reports from three different cancer centers. (2nd opinion and 3rd opinion.) The first had no info about the Her2 except negative. The second... I can't remember. The third had the IHC and FISH results that show Her2 1+ or Her2 2+ or whatever. I don't know how long path reports have been showing that, but every path lab is different.

fredntan, I am looking into a couple other trials. The Roswell Cancer Center vaccine trial is still looking for people, but you must have a tumor sample that expresses NY-ESO-1. I don't know what percentage of breast tumors do express that. I don't think it's too many but I'm not sure. There is a hold up right now, as they don't have the agent they need to test the tumor samples for NY-ESO-1. They are taking names on a list though.

The problem is I am now more than six months out from treatment. Very few trials are interested in patients who are already done with treatment.

The two best sites I know of for zeroing in on appropriate trials are breastcancertrials.org and emergingmed.com

Kay_G

So now that I have started this, I am really curious about it.  I had the skin test yesterday, with a control injection three inches below that.  When it was first injected, it immediately got red and puffed up (the control didn't though), but within a minute, it was normal, and you could just see the injection spot.  Is that how it would usually be?  Are they hoping when they do it again at the end of the trial that there will be a reaction from the vaccine (if you're getting that and not the placebo)?

Also, I'm really curious about the better results with the low Her2 than the women who took Herceptin.  I have a theory that it's the law of diminishing returns.  If you've already had Herceptin, then you can only treat that part of the cancer so much and keep getting benefits vs. someone who hasn't used any treatment targeted against HER2.  Just a thought.  Another thought was that the selection criteria allowed anyone to take part who was considered Her2 positive, but otherwise I think you had to have nodal involvement.  Perhaps the low Her2 women were in general a higher stage of diagnosis and maybe that has something to do with it.  It doesn't seem like that should make a difference to me though since they are speaking relatively. 

Thanks again Tectonic for starting this thread and letting all of us know about the trial.  Whether I end up with the placebo or not, I am glad to be part of it.  I hope they end up with great results and it becomes the standard of care.

fredntan

Had my fourth injection monday. And went by my fav new consignment shop on the fort myers base in DC. I got some deals today and cheap!

fredntan

Do any of youll think your having any side effects? I have had this slight shortness of breath since last week. Seemed to have started few days after my fourth injection. Its just ever so slight. It doesnt affect metoo much. I did 40 minonbouncy eliptical and yoga class today. Its probably a result of my pushing myself too hard.



Lately I go to gym almost every day, turned vegan. I still have the slight bruising on legsfrominjection

Momof2inME

Hi Ladies,

Is this trial still open? I went to the website and it says it is but the page was last updated Nov. 2012. I am about to have my last Herceptin and wondered if I should get the enrollment process going or wait until I have actually had the last Herceptin. Thanks for any input.

HUGS!

TectonicShift

Yep still open

Momof2inME

Thank you!

I emailed Heather today about what the first step is and when I should get the ball rolling.

Shari0707

If I read her-2 zero somewhere would it b likely I would read differently from another pathologist? I always wonder if maybe I am one or two not zero bc I read so much it varies from test to test and pathologist to pathologist.

TectonicShift

Shari,

It's true that another path report might specify Her2 1+. Especially if the second pathologist is using a CLEAN SLIDE to test. If you get a second opinion, you might want to specify that a clean slide be sent. (Clean unstained slice of your breast tumor or a nodal tumor.)

TectonicShift

Momof2, that's great! Heather is so great!

Shari0707

The pathologists never tested for her 2 or er/pr when and where I got my original biopsy.. After that biopsy and i actually found a doc.. they biopsied a lymph node that came back positive... With that lymph node they tested for all e receptors... Do u think testing the lymph node is as accurate as if it was from the tumor.. The docs assure me it is. And that's why they did it. And that it is cancer cells for original tumor regardless.. I always worried that maybe the her 2 status waould be different if it was tested on tumor not lymph node biopsied sample.. I tested as zero and I am not upset with that I just want to make sure I can get all treatment available to me.. I am currently still I treatment... Having Chemo first and then surgery.. At surgery doc says they will test for everything again anyway.. Er, pr and her2... When I s this treatment available .. Do I have to have finished treatment and surgery? Thanks tectonicshoft