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Topic: AE37 Vaccine Trial - for recently treated high-risk patients

Forum: Stage III Breast Cancer — You are not alone. Meet others who have Stage III breast cancer.

Posted on: Sep 28, 2012 09:33PM, edited May 21, 2014 12:58PM by TectonicShift

TectonicShift wrote:

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Nov 5, 2012 11:59PM lightandwind wrote:

Special K, thank you! Interesting. Glad to know the placebo isn't a sugar pill since I don't eat sugar anymore.  sure would like to know which one I'd be getting though. Are the side effects you have the same as those that they say may occur? I wonder if there is a way to find out which one you have by how you feel?

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Nov 6, 2012 06:59AM TectonicShift wrote:

GCE, 

The Phase II trial that we are in will probably be closed by the time you are done with Herceptin. But the Phase III trial should be up and running by then. So that's great! You should be able to get in the Phase III trial, and that will be a much larger trial so there will likely be a location closer to you. (In the Phase II trial there are only about 8 or 9 sites in the whole country, many of which are only open to military members.)

Keep an eye on the clinicaltrials.gov Web site for AE37 Phase III. Search for those terms periodically. Also when the Phase III trial opens I will post it here.

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Nov 6, 2012 07:04AM TectonicShift wrote:

Even if you get the placebo, you do get an immune system booster. AND you are first in line to get the vaccine as soon as it is approved. I think it's good to do the trial even if you get the placebo. You are "in the system" and plugged in to the latest vaccine info.

BTW there is another trial going on for NeuVax vaccine. That's in Phase III trial. You can find that info by searching the clinicaltrials.gov for NeuVax or E75. (E75 is the real name of the NeuVax vaccine.) The only problem with that is you have to get your tissue typing done (it's a blood test) and NeuVax only works on HLA-A2+ or HLA-A3+. 

In the AE37 trial, you can be any HLA tissue type. So more people are eligible.

Oh, one more thing. You cannot have any autoimmune diseases and get on the AE37 trial.

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Nov 6, 2012 09:13AM fredntan wrote:

And the neuvax people wouldnt accept me since i had 13 + nodes.

I think i might be getting the placebo since i didnt feel icky, but being 4 weeks out from diep, maybe i dont know what good feels like

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIa, Grade 2, 13/17 nodes, ER+/PR+, HER2- Dx 10/2013, Stage IV, mets Hormonal Therapy Tamoxifen Surgery 09/09/2011 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 10/20/2011 Adriamycin, Cytoxan, Taxol Radiation Therapy 03/29/2012 External Surgery 10/08/2012 Reconstruction: DIEP flap (Both) Surgery 04/03/2013 Reconstruction: Nipple reconstruction (Both) Chemotherapy 10/23/2013 fluorouracil, Mitomycin Chemotherapy 11/20/2013 Abraxane, fluorouracil
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Nov 6, 2012 10:20AM SpecialK wrote:

Just wanted to clarify that in our trial there is still a sort by histological type - the A2negative types go to the AE37 arm and the A2positive go to the GP2 arm.  I worked in Transfusion Services at the time I was diagnosed and a friend I worked with at that time went to work doing histological typing for the lab that handles organ transplants here in Tampa.  She did my typing - I am A2+, so I know I am sorted into the GP2 arm, but don't know if I am getting the vaccine or placebo. 

In terms of being able to figure out what you are receiving - I think the SE are too nebulous to determine it.  Some of the SE from the sargramostim mimic the SE from the vaccine.  I don't feel very well after the injection but I didn't feel very well after Neulasta either, so...  The placebo is a similar drug so I think it is impossible to tell.

Dx 9/27/2010, DCIS, Stage 0, Grade 3 Dx 9/27/2010, IDC, 2cm, Stage IIb, Grade 3, 2/14 nodes, ER+/PR+, HER2+ Surgery 11/01/2010 Mastectomy (Both); Reconstruction: Tissue expander placement (Both) Surgery 12/06/2010 Lymph Node Removal: Axillary Lymph Node Dissection (Right) Surgery 12/14/2010 Reconstruction (Both) Surgery 12/21/2010 Reconstruction (Left) Surgery 01/07/2011 Reconstruction (Left) Surgery 01/21/2011 Reconstruction (Left) Chemotherapy 02/17/2011 carboplatin, Taxotere Targeted Therapy 02/17/2011 Herceptin Surgery 07/20/2011 Reconstruction: Tissue expander placement (Left) Hormonal Therapy 08/01/2011 Femara Surgery 02/24/2012 Reconstruction: Breast implants (permanent) (Both) Hormonal Therapy 06/20/2012 Arimidex Surgery 12/14/2012 Reconstruction (Both) Hormonal Therapy 07/18/2013 Femara Surgery 03/07/2014 Reconstruction (Both) Surgery 04/02/2014 Reconstruction: Breast implants (permanent) (Left) Surgery 05/09/2014 Reconstruction (Left) Surgery 11/13/2014 Reconstruction (Left)
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Nov 6, 2012 10:44AM TectonicShift wrote:

Right. I'm HLA-A2 negative and HLA-A3 negative, so I am in the [AE37 or placebo] arm.

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Nov 6, 2012 02:25PM fredntan wrote:

And I felt fine after neulasta. So who knows. Hey mods I think I hit report post. It was mistake

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIa, Grade 2, 13/17 nodes, ER+/PR+, HER2- Dx 10/2013, Stage IV, mets Hormonal Therapy Tamoxifen Surgery 09/09/2011 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 10/20/2011 Adriamycin, Cytoxan, Taxol Radiation Therapy 03/29/2012 External Surgery 10/08/2012 Reconstruction: DIEP flap (Both) Surgery 04/03/2013 Reconstruction: Nipple reconstruction (Both) Chemotherapy 10/23/2013 fluorouracil, Mitomycin Chemotherapy 11/20/2013 Abraxane, fluorouracil
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Nov 11, 2012 09:33AM MiniMacsMom wrote:

So I got a call back but we were at dinner with friends. They said you have to enroll first then go down for a week. Then 3 days every 3-4 weeks. Then the boosteres every 6 no but after the boosters you have to go back two weekslaterlater. I didn't know about the two visits every 6 mo. She is gonna CA back Tuesday to talk some more about it.

Diagnosis: 10/25/2011, IDC, 9cm, Stage IIIa, Grade 3, 4/15 nodes + Rotter's Node, ER+/P+-, HER2-, BRCA 2+
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Nov 11, 2012 10:56AM Maggs09 wrote:

Can someone, please explain what exactly HLA A2 and A3 stands for and it's significance. How do I know if I'm positive or negative?
How is it related to HER2?
I'm confused...
Thanks!
Mahda

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 11, 2012 11:13AM , edited Nov 11, 2012 11:18AM by TectonicShift

HLA refers to tissue typing and which antigens are in your blood -- your HLA types are determined by a blood test. Typically it is done when you are being considered for an organ transplant, to see if you are a match with someone to receive or donate and organ. Your HLA types is something you inherit from your parents. The blood test determines which antigens are in your blood.

You have to be HLA-A2 or HLA-A3 to get Neuvax E75 vaccine.

But for the AE37 vaccine, you can either have the A2 and A3 antigens or not. It doesn't matter. They have one vaccine for A2+ or A3+ and they have a different one for A2- and A3-. So the AE37 trial can accept many more people.

You wouldn't have any way of knowing your HLA type until you joined a trial. There is no reason your onc would do the test.

(Although I asked my onc to do the test so I could know whether I would qualify for the Neuvax E75 vaccine. Turns out I'm A2 negative and A3 negative, so I wouldn't qualify for that one anyway. Asking my onc to run the test just saved me some time and trouble. I know I can never do the E75 vaccine as it won't work on me.)

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Nov 11, 2012 11:18AM Maggs09 wrote:

Thank you for explaining.
Does this HLA have any impact on prognosis as well?

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 11, 2012 11:21AM , edited Nov 11, 2012 11:26AM by TectonicShift

No, none. It's just that the vaccines are designed to work on particular HLA types.

If you are A2 positive or A3 positive, the E75 (Neuvax) vaccine might be for you.

If you are A2 negative and A3 negative, the AE37 vaccine would be the one you'd want to investigate. (Though that trial has a vaccine for A2+/A3+ as well, called the GP2 vaccine.)

But you can't know which HLA type you are unless you get someone (the trial researchers, or your onc) to give you the test. It's just a blood test. If you start the process to join a vaccine trial, it's one of the first things they will do, test your blood for HLA type.

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Nov 11, 2012 11:30AM Maggs09 wrote:

Being HER 2 "0", I don't qualify for AE37;
I think Neuvax E75 is also only for HER 2 at least 1 or higher, am I correct?
I have a friend (35), who is triple neg, had neojuvant chemo with "0" response, surgery and just finished rads. She is doing great, but I think this vaccine trial would be something for her...

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 11, 2012 11:36AM , edited Nov 11, 2012 11:47AM by TectonicShift

Maggs,

Go to another oncologist at another hospital, preferably an NCI designated cancer center, and have them request a clean slide of your tumor and do a brand-new path report. See if you get the same path report numbers.

My Her2 receptor info was different on each of the three path reports I had done. 

I had consults at Dana Farber, Tufts, and Mass General, and all three path departments gave me different numbers for ER, PR, and HER2. Really! It's kind of a subjective science.

So go see if another cancer center also gives you Her2-0. If they find even a little bit of Her2 receptors, maybe you could get on the trial.

Do not be shy about this. Another onc should be able to help you arrange to get a clean slide of your tumor for a "second opinion" path report. It's very normal. People do it all the time.

And yes, the AE37 trial is showing fantastic results for triple negative so far. (Early days yet but if I was TNBC I would be thrilled to see the results.) Have her PM me if she wants particulars. Or just send her to the trial sheet listed above.

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Nov 15, 2012 01:46PM MiniMacsMom wrote:

Hey guys, Just talked to MDA's enrollment nurse.  I will enroll when I got down in January.  It ends up being like 15 visits over thd course of the 2.5 years. 

**She did say that you are NOT going to get the vaccine if you are on the control arm.  The earliest it will be ready for production is 4 years and we will all be out of the "window" for receiving it.  She said that needs to come out of the enrollement paperwork. 

**Also, I am BRCA pos and its not an exclusion, which is really exciting. 

Hope you guys are doing well. 

Diagnosis: 10/25/2011, IDC, 9cm, Stage IIIa, Grade 3, 4/15 nodes + Rotter's Node, ER+/P+-, HER2-, BRCA 2+
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Nov 15, 2012 02:34PM Maggs09 wrote:

Hi MiniMom, are you HER2 negative but higher then "0"?
I was looking into this trial but my path shows HER2 0 and apparently this is an exclusion. I have already started a request of having my pathology "retested" by independent pathologist.
But it may take about 6-8 weeks for everything to be completed.
I hope you had a great weekend! Please, email me when you have time.
Magda

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 15, 2012 06:29PM , edited Nov 15, 2012 06:31PM by TectonicShift

Ugh, MiniMacsMom, I hope that is not right about the control group not getting vaccine. That is not what I was told. The nurse at my place said if we are getting placebo now then we would get vaccine once it's approved. I sure hope so. If we have not recurred, why not?  There's almost no toxicity.

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Nov 15, 2012 06:30PM MiniMacsMom wrote:

Magda, I am Her2 +1, which is still technically Her2 negative.  THats my MDA score, I had a higher Her 2 score and FISH score from Vandy, but MDA used their own.  With the vandy score I could have done the Neuvax, but not with MDA's score.  Weird huh!

Diagnosis: 10/25/2011, IDC, 9cm, Stage IIIa, Grade 3, 4/15 nodes + Rotter's Node, ER+/P+-, HER2-, BRCA 2+
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Nov 15, 2012 06:47PM Maggs09 wrote:

That's great that you can still qualify. Like I said I'm in the process of getting my path re-done by pathologists associated with Harvard, like one other girl recommended. Who knows if it still going to be the same or different. It doesn't hurt to try and it's not costing me anything as it is a part of my benefits. I read a lot about the vaccine and it looks promising.

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 15, 2012 09:03PM MiniMacsMom wrote:

Tech:  I hope the nurse from MDA is wrong also.  I don't see why it would hurt? But she said her principle investigtor at MDA said that statement was wrong.  Who knows, I guess if its in the release you can always try to fight for it! 

Magda:  Yay for the Harvard review! I have been scouting the vaccines for a while, but this is the first that I actually qualify for.  Not looking forward to the 15 flights down to MDA, but hey if it works thats amazing!  The nurse also said that if I do recon at MDA, the visits can co-incide and that you have to visit ALOT for recon.  She even said that if you do a TRAM flap you spend 3-4 days in ICU down there.  I guess I will find out more about all of it in January!  You have 6 mo from the time you are finished with your treatment to enroll, so after Christmas, when  you are done with rads you can look into it.  MDA said they only have 24 spots left, but they won't be enrolling anyone else til after the holidays.  So I wouldn't worry too much about your path reports taking 6 weeks!

Diagnosis: 10/25/2011, IDC, 9cm, Stage IIIa, Grade 3, 4/15 nodes + Rotter's Node, ER+/P+-, HER2-, BRCA 2+
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Nov 24, 2012 05:26PM TectonicShift wrote:

Latest news:  http://www.redorbit.com/news/health/1112730352/generex-provides-update-on-company-initiatives-including-the-ae37-breast/

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Nov 24, 2012 07:03PM fredntan wrote:

I read that earlier today. Does this mean they are going to start phase 3 soon?

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIa, Grade 2, 13/17 nodes, ER+/PR+, HER2- Dx 10/2013, Stage IV, mets Hormonal Therapy Tamoxifen Surgery 09/09/2011 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 10/20/2011 Adriamycin, Cytoxan, Taxol Radiation Therapy 03/29/2012 External Surgery 10/08/2012 Reconstruction: DIEP flap (Both) Surgery 04/03/2013 Reconstruction: Nipple reconstruction (Both) Chemotherapy 10/23/2013 fluorouracil, Mitomycin Chemotherapy 11/20/2013 Abraxane, fluorouracil
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Nov 24, 2012 07:35PM mary625 wrote:

I really hope I can get into Phase III. They wouldn't let me in Phase II because of Hashimoto's thyroiditis which is classified as an anti-immune disorder.

Dx 8/29/2011, ILC, 1cm, Stage IIIc, Grade 2, 10/16 nodes, ER+/PR+, HER2- Chemotherapy 09/26/2011 Adriamycin, Cytoxan, Taxol Surgery 02/06/2012 Mastectomy (Both); Lymph Node Removal: Axillary Lymph Node Dissection (Left) Hormonal Therapy 03/12/2012 Femara Radiation Therapy 03/13/2012 External Surgery 09/24/2014 Reconstruction: DIEP flap (Both)
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Nov 24, 2012 08:33PM Maggs09 wrote:

Mary, do you know if for Phase III they will still be only accepting HER2 of at least 1 or higher?
My path report shows HER2-0.

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 24, 2012 08:36PM , edited Nov 24, 2012 08:37PM by TectonicShift

I think it means the phase II trial will end early and the much larger phase III trial will begin sometime in 2013.

I think the latest results from the phase II trial will be announced at San Antonio in a couple of week.s

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Nov 24, 2012 08:58PM fredntan wrote:

I am confused. I just started phase 2 last month.

Fran Dx 8/3/2011, IDC, 2cm, Stage IIIa, Grade 2, 13/17 nodes, ER+/PR+, HER2- Dx 10/2013, Stage IV, mets Hormonal Therapy Tamoxifen Surgery 09/09/2011 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 10/20/2011 Adriamycin, Cytoxan, Taxol Radiation Therapy 03/29/2012 External Surgery 10/08/2012 Reconstruction: DIEP flap (Both) Surgery 04/03/2013 Reconstruction: Nipple reconstruction (Both) Chemotherapy 10/23/2013 fluorouracil, Mitomycin Chemotherapy 11/20/2013 Abraxane, fluorouracil
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Nov 24, 2012 09:12PM , edited Nov 24, 2012 09:14PM by TectonicShift

People who have already started the phase II trial will keep going and will continue to be followed. It's just that sometime in the first half of 2013 they will stop admitting people into the phase II trial. And shortly after that they will begin the phase III trial. If you are already in phase II, you will stay in it and finish it.

I'm not sure who will be admitted to phase III, but it looks like they might exclude the her2-positive (her2-3+) patients. 

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Nov 24, 2012 09:14PM Maggs09 wrote:

Does anyone know anything more about eligibility criteria for phase III?

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen
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Nov 24, 2012 09:15PM TectonicShift wrote:

Maggs, when will your new path report be done?

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Nov 25, 2012 10:14AM Maggs09 wrote:

I've already got all paperwork submitted last Friday , (consents and all), and was told that because my situation is complicated it may take about 5-8 weeks to get full report. They will re-do full pathology for breast and colon, review all scans from the start before they can do a full report and provide own recommendations. Since original stuff was done at the University Health Network in Toronto, new review will be done either at MDA or Sloan K in New York. I guess they will try to match the best combination of specialists with patient-specifics.
I just hope that my colon and Her2 at 0 will not "cut me out" again from being on the vaccine trial.

Dx 5/14/2012, ILC, 6cm+, Stage IIIc, Grade 2, 16/18 nodes, ER+/PR+, HER2- Surgery 05/02/2012 Lumpectomy (Right) Surgery 06/27/2012 Mastectomy (Right); Lymph Node Removal: Axillary Lymph Node Dissection (Right) Chemotherapy 08/01/2012 Adriamycin, Cytoxan, Taxol Radiation Therapy 12/12/2012 External Hormonal Therapy 12/28/2012 Tamoxifen

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