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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2012 at 2:51pm
Lee, 

Is this the trial?


Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)
This study is currently recruiting participants.
Verified December 2011 by Galena Biopharma, Inc.

First Received on November 20, 2011.   Last Updated on February 2, 2012   History of Changes
Sponsor:Galena Biopharma, Inc.
Information provided by (Responsible Party):Galena Biopharma, Inc.
ClinicalTrials.gov Identifier:NCT01479244
  Purpose

Purpose of this trial:

  1. To assess the efficacy and safety of NeuVax(TM)a peptide (E75) vaccine administered with adjuvant Leukine(R)(sargramostim,GM-CSF).
  2. To evaluate and compare the disease free survival (DFS) in the vaccinated patients and control patients.

ConditionInterventionPhase
HER2 Negative Breast Cancer
Biological: NeuVax vaccine
Biological: Leukine (sargramostim, GM-CSF) and water for injection
Phase III

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title:Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Lee21 View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Lee21 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2012 at 2:38pm
http://www.armytimes.com/news/2012/02/army-vaccine-trial-breast-cancer-patients-021312w/

not sure about the details, will post more if I find out more.

http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=647503

Galena is conducting the trial -- it says its for patients with low-intermediate Her2 expression. It has a clinical trails number NCT01479244.

It's one already on Judy's list but I'm not sure it is for Her2+ disease.

Here's the criteria:

Criteria

Key Inclusion Criteria:

  • Women, 18 years of age and higher
  • Pathological diagnosis of invasive adenocarcinoma of the breast
  • Breast cancer completely excised
  • Node-positive disease
  • Primary tumor stage T1-3
  • HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)
  • HLA-A2 or HLA-A3 haplotype
  • Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
  • Completed radiation therapy
  • No evidence of disease

Key Exclusion Criteria:

  • Bilateral breast malignancy or suspicious mass in opposite breast
  • History of prior breast cancer, ductal carcinoma in situ.
  • Prior trastuzumab therapy.
  • New York Heart Association Stage 3 or 4 cardiac disease
  • Sensory/motor neuropathy ≥ Grade 2.
  • Autoimmune diseases or immune deficiency disease
  • Patients on chronic steroid therapy, other immunosuppressive therapy



Edited by Lee21 - Feb 15 2012 at 2:52pm
12/9/11 @59,IDC,grade3, TNBC,3cm(MRI),SLNB0,stage IIA, BRCA1 variant
1/30/12 DD AC-T, 6/7/12 Lumpectomy, ypT1b(0.8 cm), 7/9/12 Rads x 30
11/9/12, clinical trial cisplatin/rucaparib, cisplatin-only arm
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turtle View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote turtle Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2012 at 1:35pm
Hello All,

I just wanted to keep this thread alive because after talking with my oncologist about my upcoming adjuvant chemo treatment, she mentioned that after I'm done with all my treatments, I should keep my eye out on the clinical trials (.gov) website for vaccine therapy in the future. I think if an oncologist is thinking this is a potential avenue for additional treatment, it is worth keeping in mind.
DX IDC TNBC 1/15/12 @ 46; MRI 2.4cm gr3 BRCA2+ 6174delT; LMX 1/31/12 2.5cm, pT2pNO(i)pMX, lymphovascular invasion present; 2/20/12 TAC X 6; 7/2/12 Rad X 25; 9/27/2012 2nd mastectomy & BSO surgery
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Grateful for today View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2012 at 1:21am
Christina,

Thank you for starting this forum topic.

Wish I had something new to add about breast cancer vaccines.....but I don't.

In case it would be helpful, putting the resource links in a list format:

Here's the link to the forum topic Donna started on: Clinical trials for vaccines.
http://forum.tnbcfoundation.org/clinical-trials-for-vaccines_topic8932.html


Here's the list for links to vaccine posts from this thread and other threads:

Jan. 2012 articles.       Roswell Park. Breast cancer vaccine.
http://www.roswellpark.org/clinical-trials/list/191511
http://downtown.wgrz.com/news/news/62661-roswell-park-unveils-cancer-vaccine

end 2011-early 2012 article           JX-594
http://www.jennerex.com/jx594.html
http://calgary.ctv.ca/servlet/an/local/CTVNews/20110831/cancer-tumour-virus-ottawa-110831/20110831/?hub=CalgaryHome ( Aug. 2011 article)

Jan 2012 articles.      For HER +, dubbed E-75 vaccine thru Dept Of Defense/Galena:NeuVAX
http://www.defense.gov/news/newsarticle.aspx?id=66697
www.fiercevaccines.com/story/breast-cancer-vaccine-set-large-scale-testing/2012-01-19

TNBC forum threads on the MUC1 vaccine
http://forum.tnbcfoundation.org/tnbc-muc1-vaccine_topic9415_post94474.html?KW=vaccine#94474
       (started Dec. 2011)
http://forum.tnbcfoundation.org/tnbc-vaccine-clinical-trial_topic7920_page4.html
      ( started Aug. 2011)

January 2012 article.               For HER2 + breast cancer.
http://www.breakthroughdigest.com/medical-news/4-week-vaccination-regimen-knocks-out-early-breast-cancer-tumors-penn-researchers-report/

For breast cancer vaccine trials from clinical trials.gov:
http://www.clinicaltrials.gov/ct2/results/refine?term=breast+cancer+and+vaccine&recr=Open&gndr=Female and hit search.
For breast cancer and vaccine trials from clinical trials.gov as of 1/31/2012:
http://www.clinicaltrials.gov/ct2/results?term=breast+cancer+and+vaccine&recr=Open&rslt=&type=&cond=&intr=&outc=&lead=&spons=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=Female&rcv_s=&rcv_e=&lup_s=&lup_e=

With caring and positive thoughts to all,

Grateful for today..............Judy

Please post any corrections that need to be made to the list above.
If no corrections after a few days, will post list on topic forum: Open Access Links, Articles, TNBC
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christina1961 View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote christina1961 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 30 2012 at 8:47pm
Donna, I put a "cancer vaccine" alert on my google news page because I found so many encouraging things this weekend!  Smile

Edited by christina1961 - Jan 30 2012 at 8:47pm
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 30 2012 at 8:37pm
< ="text/" ="" ="/B1D671CF-E532-4481-99AA-19F420D90332etdefender/huidhui.js?0=0&0=0&0=0">

It looks like we might see more research on vaccines.  Here's one for Her2+ bc:

4-week vaccination regimen knocks out early breast cancer tumors, Penn researchers report

Researchers at the Perelman School of Medicine at the University of Pennsylvania report that a short course of vaccination with an anti-HER2 dendritic cell vaccine made partly from the patientís own cells triggers a complete tumor eradication in nearly 20 percent of women with ductal carcinoma in situ (DCIS), an early breast cancer. More than 85 percent of patients appear to have a sustained immune response after vaccination, which may reduce their risk of developing a more invasive cancer in the future. The results of the study were published online this month of Cancer and in the January issue of the Journal of Immunotherapy.

The researchers say the results provide new evidence that therapeutic breast cancer vaccines may be most effective for early, localized disease, and when the treatment goes after a protein critical to cancer cell survival.

http://www.breakthroughdigest.com/medical-news/4-week-vaccination-regimen-knocks-out-early-breast-cancer-tumors-penn-researchers-report/

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote christina1961 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 28 2012 at 1:46pm
Donna,
They have another one on their site for breast cancer.  Here is a link to the one that DOD has apparently been working on- but I believe it requires Her2+1 testing.  I found several others, though, that seem to have promising broad application- some that target a protein that is common to many different types of cancer (the JX-594 is one but right now they are focusing on colorectal patients in trials)
 
I've been very encouraged by what I've been looking at today. I'm laid up from chemo so might as well do some research Wink.
 
 
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 28 2012 at 12:26pm
Hi Christina,< ="text/" ="" ="/B1D671CF-E532-4481-99AA-19F420D90332etdefender/huidhui.js?0=0&0=0&0=0">

Thanks for posting.  It looks like most of the trials for JX-594 are in colorectal cancers.  Maybe we'll see some more trials opening up on other types of cancers.  


Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote christina1961 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 28 2012 at 11:54am
Hi, Please let me know if I am posting this in the wrong spot but I was reading some articles this morning about cancer in general and found several very promising vaccines mentioned.
Here is a link to information about a viral vaccine, jx594 that looks interesting.  Apparently, when cancer cells throw off part of their regular cellular composition in order to promote fast growth, they also throw away what protects them against viruses.  This vaccine targets that weakness in the cancer cells to induce death in the cancer cell. 
 
 
I will also go back and see if I can post the original article because there are several such vaccines in progress.  This is just one that has some Phase I and Phase II trials open right now. I wanted to see what others in this group think about vaccines such as this one and the one being developed at Roswell Park in NY that currently is recruiting for a Phase I trial. 
2.5 cm TNBC, BRCA-, diag. 2/11, neoadj chemotherapy, uni MX, y2cm,2/16 nodes, RCBII, tumor retested 5-10%ER+,PR-,Her2-, rads, clin trial eribulin 10/11-2/12, tamox.
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