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Old 06-28-2008, 09:01 PM   #1
eric
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Vaccine Successfully Enters Phase-II Trial

http://www.allheadlinenews.com/articles/7011409961

Washington D.C. (AHN) - A breast cancer vaccine currently being tested in a Phase II trial at various hospitals has yielded positive results and is targeted towards women who've already had metastatic breast cancer.
The therapeutic breast cancer vaccine AE37 uses a peptide antigen of a cancer gene known as HER-2/neu. This gene/protein is present in many types of cells, but it is over-expressed in a high proportion of breast cancers as well as many others.
Researchers say that they are seeking to evaluate the efficacy of two anti-cancer vaccines targeted to the HER 2 protein, which is expressed in 60 to 70 percent of all breast cancers.
Researchers believe that if the woman if an immune responder, she has double the survival rates as compared to non-responder.
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Old 10-09-2008, 06:18 PM   #2
Janelle
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It was my understanding that this trial is NOT targeted toward women with metastatic breast cancer. My understanding is that this vaccine is being tested in HER2 positive women who are currently NED but at high risk for recurrence and have never had a metastisis. The goal is to try to find out if the vaccine prevents spread.

I also understand that the reason they are testing this out in non-metastatic women without current evidence of disease is that in theory this particular vaccine may work better in women with a low disease load.
__________________
Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 10-09-2008, 07:27 PM   #3
Rich66
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"the HER 2 protein, which is expressed in 60 to 70 percent of all breast cancers."

60 to 70 percent? They must be including some who are currently considered her2 negative.
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Mom's treatment history (link)
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Old 10-09-2008, 07:53 PM   #4
Janelle
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Yes, I was wondering about that 60-70% stat too. I figured it must include those who overexpress HER2 to a slight degree. There is a subset of Her2 positve population that overexpresses HER2 but are not candidates for Herceptin because they don't overexpress it "enough". From what I understand the "low" HER2 overexpressers is the population that benefitted the most from this vaccine in the phase I trial. But it is possible that the high overexpressers don't see as great a benefit because they were previously pre-treated with Herceptin.

I am a high over expresser of Her2. I'm starting this trial on Monday. It probably won't do me any good....and I have a 50% chance of getting randomized into the placebo arm. I'll let you know if I learn anything new. I'm enrolling at MD Anderson.
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Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 10-09-2008, 09:21 PM   #5
chrisy
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I think this is just a badly written article, and the writer got the stat wrong. It says the Phase I trial was with node negative, so definitely not metastatic.

To me, it's not clear if people with metastatic history would be eligible for this trial or not...it doesn't specifically EXCLUDE but you do have to be NED. So it's hard to tell if the study really includes those people or if it another instance of "badly written or misunderstood" Link to the trial is below.

http://clinicaltrials.gov/ct2/show/r...cine%22&rank=1
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Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 10-10-2008, 03:15 PM   #6
dhealey
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I am currently enrolled in this trial at Wake Forest @ Baptist Hospital in Winston Salem, North Carolina. I have had my 3rd vaccine last week and have thus far tolorated them well except for a great deal of swelling at the injection site that lasts for about 1 week. This is very exciting as it is the beginning for finding a vaccine to prevent Breast Cancer in all women. Right now they are seeking women who are no longer than 6 months out of treatment, high risk and her2 poisitive. Glad to hear you will also be starting the trial Janelle. Good Luck
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Debbie in North Carolina
Diag 10/2006-high grade invasive ductal carcinoma- mastectomy L breast
2.5 cm tumor ER/PR pos-Her2+++
4 rounds A/C, 4 rounds Taxol
Herceptin every 3 weeks until Jan. 2008
6/18/07 prophylatic mastectomy R breast
8/2007 started aromasin/stopped arimidex (side effects)
12/07 stopped aromasin due to side effects (now what?)
Finished herceptin 1/8/08
started tamoxifen for 2 years then will switch to femera
allergic to tamoxifen started femera 4/2008
June 20, 2008 portacath removed
Learnig to live life to the fullest!
Stopped Femera due to side effects
July 28, 2008 start trial for breast cancer vaccine
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Old 10-11-2008, 12:00 AM   #7
Janelle
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Thanks for the encouragement, Debbie. Do you bones hurt after the injection?

Any other symptoms? I was told I might experience flu like symptoms.....I just want to mentally prepare. Thanks!

Janelle
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Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 10-11-2008, 06:04 AM   #8
dhealey
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Janelle, I do not have any bone pain from the vaccine. I do feel tired for about 24 hours after the injection, sometimes with a slight headache about 2 hours after getting the injection, but this goes away by the next day. I have so far found this to be very tolerable. Best of luck! Debbie
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Debbie in North Carolina
Diag 10/2006-high grade invasive ductal carcinoma- mastectomy L breast
2.5 cm tumor ER/PR pos-Her2+++
4 rounds A/C, 4 rounds Taxol
Herceptin every 3 weeks until Jan. 2008
6/18/07 prophylatic mastectomy R breast
8/2007 started aromasin/stopped arimidex (side effects)
12/07 stopped aromasin due to side effects (now what?)
Finished herceptin 1/8/08
started tamoxifen for 2 years then will switch to femera
allergic to tamoxifen started femera 4/2008
June 20, 2008 portacath removed
Learnig to live life to the fullest!
Stopped Femera due to side effects
July 28, 2008 start trial for breast cancer vaccine
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Old 10-11-2008, 10:20 PM   #9
Shobha
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Hi, can anyone tell me how to enroll in this trial? I was diagnosed with Stage IIIb Her 2 positive cancer in June of 2007. I finished my treatment in July 2008. Thanks!
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Old 10-12-2008, 02:25 AM   #10
Janelle
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HER2 trial

You need to enrol within 6 months of your last herceptin treatment. I can give you more details later....just remind me. I just got home from a wedding and I need to fly to MD Anderson tomorrow....YIKES!

Otherwise, maybe Dhealty (Debbie) can direct you to info about the trial.
__________________
Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 10-12-2008, 12:46 PM   #11
dhealey
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Location: moved to Lancaster, Pa in June, 2010
Posts: 576
Shobha, The clinical trial can be found on www.clinicaltrials.gov search for the trial by this NCT00524277. The trial is being conducted thru Walter Reed Hosp. in DC There are six testing sites here in the US and 1 in Greece. I am participating in the on at Wake Forest Baptist Hops. in Winston Salem, North Carolina. You must be her2 positive and no longer than six months out of treatment.
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Debbie in North Carolina
Diag 10/2006-high grade invasive ductal carcinoma- mastectomy L breast
2.5 cm tumor ER/PR pos-Her2+++
4 rounds A/C, 4 rounds Taxol
Herceptin every 3 weeks until Jan. 2008
6/18/07 prophylatic mastectomy R breast
8/2007 started aromasin/stopped arimidex (side effects)
12/07 stopped aromasin due to side effects (now what?)
Finished herceptin 1/8/08
started tamoxifen for 2 years then will switch to femera
allergic to tamoxifen started femera 4/2008
June 20, 2008 portacath removed
Learnig to live life to the fullest!
Stopped Femera due to side effects
July 28, 2008 start trial for breast cancer vaccine
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Old 10-12-2008, 08:31 PM   #12
Shobha
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Thanks Debbie and Janelle! I was Her2 positive and my herceptin treatment finished on July 11, 2008. Since it is within 6 months of my last herceptin treatment, I really really hope I can get enrolled.
I am 40 years old and have two children 5 and 4 and want to see them graduate out of college so very much !!
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Old 10-19-2008, 03:10 PM   #13
Janelle
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I had my first injectin on Wednesday, Oct. 15.

I experienced fluid retention in my ankles within 2 hours of receiving my first injection. Apparently this is a somewhat uncommon side effect but they have noticed it in 10% of the patients so far. I was also very tired for the next 24 hours and I still feel more fatigued than usual today.

I had very minor swelling at the injection site but I was told this could get worse after subsequent injections. Of course, I may be getting the placebo arm too....
__________________
Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 01-24-2009, 01:53 PM   #14
Carolina59
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I am currently trying to get all the paperwork, records, etc. together to enter this trial before my window closes on 2/15/09.

Does anyone know how many patients are enrolled so far at Wake Forrest?

Thanks,
Carolina
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Old 01-24-2009, 02:36 PM   #15
Janelle
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Where do you live? Fewer than 10 people are enrolled at MD Anderson right now. I can try to find out from MD Anderson if they have the enrollment stats for Wake Forrest.
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Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 01-24-2009, 06:00 PM   #16
Carolina59
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Thanks, Janelle. I am in NYC, but I have a cousin in Winston-Salem, and I grew up in Charlotte, so I think that would be the easiest place for me to go. I also have a 4 y.o. dd, so I have to figure that in to the traveling logistics, esp. since I was told I would have to spend a week there for the screening process.

I am still interested in how many are enrolled at Wake Forrest--in July someone posted that there were only 2 people enrolled. I'm sure they must have more now. I forgot to ask the nurse coordinator.
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Old 01-24-2009, 06:02 PM   #17
Janelle
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Carolina,
See below from Dr. Mittendorf at MD Anderson. I'll update you when I receive more info.
Best,
Janelle


Janelle-

I don't know the answer off the top of my head but have made an inquiry to Maureen Pavlik who should be able to find that information for us. Where is the patient living? If Houston is not out of the question I would be happy to help her enroll here.

Beth
__________________
Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 01-24-2009, 09:50 PM   #18
Carolina59
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Thanks, Janelle, I'll wait for your update.

Are you still retaining fluid in your ankles, or has it gotten better?

xo Carolina
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Old 01-24-2009, 09:54 PM   #19
Janelle
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No, the water retention only happened once. It was hot in Houston when that happened and I had just flown in and I was probably dehydrated from a wedding weekend. I'm not sure if dehydration would make one retain water though. The swollen ankles did freak me out a bit but it turned out to be nothing to worry about.
__________________
Janelle
Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS
Stage 1c triple positive, no node involvement but
vascular invasion
multifocal disease
Lumpectomy November, 2006
A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008);
Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007
Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)
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Old 01-25-2009, 06:41 AM   #20
Midwest Alice
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Janelle,
Do you have to be done with Herceptin to start the trial at MD Anderson?

Thanks
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Alice
04/08 age 50 III IBC Her2+++ ER/PR-8cm 14/14 Double M, Body and Brain CT/PET clear, ? on spine,Muga 53
06/08, 4 A/C, Neulasta
08/08, Herceptin/tax 12 every week
10/08, CT/PET clear, ? on pelvis, hips, MUGA 43, started Enalaprial for heart, Herceptin every 3 weeks
11/08 33Rads; 12/08 MUGA 48
2/09 MRI spine and bone scan, old mets to spine, Chest x-ray, blood work, IV NED,regular CPAP use,Zometa x6, first -flue like symptoms 2 days;Herceptin x3; stage 2 lymphoedema..sleeve and glove
4/09 Brain MRI - CLEAR; MUGA 54
7/09 chest ultrasound,
10/09 PET, brain and spin MRI NED Herceptin only. MUGA 59!!!
1/11 Hip replacement 7/11 Hip 2 replacement
4/12 4 years!! Herceptin
6/12 start reconstruction finish in 12/12
2/14 Herception - 6 years!!!

1 Corinthians 10:13 "No temptation has seized you except what is common to man. And God is faithful; he will not let you be tempted beyond what you can bear. But when you are tempted, he will also provide a way out so that you
can stand up under it."

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