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New TNBC Immunotherapy Trial opened

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Thriceblessed View Drop Down
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    Posted: May 10 2016 at 10:56pm
"A Vaccine + Chemotherapy to Reduce Risk of Recurrence in Triple Negative Breast Cancer" just opened and is recruiting in MD, Michigan, and TN.  For those who had Stage II or III TNBC and have completed their last cycle of chemotherapy or radiation more than 60 days prior to consent.  Read about it on breastcancertrials.org: https://mail.google.com/mail/u/0/#inbox/1549a1c5a536ef95  For more details, and other exclusion criteria, see clinicaltrials.gov NCT02593227.
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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: May 10 2016 at 11:34pm
Thriceblessed,

Thank you for posting this information.  Here is your link:


Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Tapimmune Inc.
Sponsor:
Information provided by (Responsible Party):
Tapimmune Inc.
ClinicalTrials.gov Identifier:
NCT02593227
First received: October 27, 2015
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).

ConditionInterventionPhase
Breast Cancer
Biological: Low dose FRα vaccine
Drug: Cyclophosphamide
Biological: High dose FRα vaccine
Phase 2

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer

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 Tulips Quote  Post ReplyReply Direct Link To This Post Posted: Feb 26 2017 at 9:06am
Hi everyone,

I'm just curious if anyone is participating in this trial, and if so, what has been your experience so far (side effects?).  I see that there is an extremely similar trial about to start, sponsored by NCI, and in many more locations (see below).  This one has Dana Farber as one of the locations, which is close to me, so I'm considering it.  I think you can join up to one year after your last chemo or treatment, so I guess I have until August to participate.  Part of me LOVES being done with treatment right now, but if there's a vaccine that can reduce the chance of recurrence significantly, why not?  I believe the dose of cyclophosphamide is very low, and you just get it in the beginning to prime the immune system, so it does not result in hair loss or anything like you'd experience if you had it at regular chemo-dose levels.

Thanks,
Tulips

Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by Academic and Community Cancer Research United
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Academic and Community Cancer Research United
ClinicalTrials.gov Identifier:
NCT03012100
Dx April 2015 IDC TN 2.2 cm, Grade 3, Chemo started May 2015: Taxol/Carbo then AC, Lx with SNB Nov 2015, 33 Rad Dec 2015-Feb 2016. 6 months Capecitabine starting March 2016
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Sara0414 Quote  Post ReplyReply Direct Link To This Post Posted: Mar 03 2017 at 3:10pm
Has anyone been accepted into this trial? I live near Nashville and my doctor said he would refer me to it? I still have chemo to finish but anything is worth a shot at this point?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Julierb52 Quote  Post ReplyReply Direct Link To This Post Posted: Oct 11 2018 at 10:01pm
I have been on this trial for the past year and a half. Looking for anyone out there on this trial as well to see if there are similar side effects that I am experiencing. Thank you!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 29 2018 at 10:00pm

Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer - Phase II


Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic LocationStatusContact

SCOTTSDALE/PHOENIX, ARIZ.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Contact us for the latest status

Cancer Center Clinical Trials Referral Office

855-776-0015

JACKSONVILLE, FLA.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Contact us for the latest status

Cancer Center Clinical Trials Referral Office

855-776-0015

ROCHESTER, MINN.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Contact us for the latest status

Cancer Center Clinical Trials Referral Office

855-776-0015



Edited by 123Donna - Oct 29 2018 at 10:01pm
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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