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TNBC Vaccine on the horizon

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    Posted: Oct 12 2019 at 7:27am
https://www.forbes.com/sites/robinseatonjefferson/2019/10/11/mayo-breast-cancer-vaccine-could-be-available-in-less-than-a-decade/


It sounds like this vaccine can be used to stop recurrence. Has anyone seen this before? 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 12 2019 at 1:08pm
[Were also working on one to prevent cancer with the National Breast Cancer Coalition, Knutson said. We expect that to be in phase 1 clinical trials in 2020.]  This study is not yet listed and usually phase 1 is conducted with a very small population before they can move to phase 2 status.  It usually takes many years to move from phase 1 status to public availability.

Here are the current Mayo Clinical vaccine clinical trials:



Here are the TNBC vaccine clinical trials:


Here are all the breast cancer vaccine clinical trials:

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 strongtogether Quote  Post ReplyReply Direct Link To This Post Posted: Oct 12 2019 at 4:58pm
I5 almost sounds too good to be true..... but those timeframes are so long. The other thing is that they dont always pass clinical trials. 


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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 13 2019 at 12:53pm
I agree.  It can take well over a decade for a clinical trial to move through the process and many will not ultimately be approved.  The clinical trial I participated in, a phase 3 open access, ultimately did not meet FDA approval. 

This is from the ACS:

"Clinical trials are only a small part of the research that goes into developing a new treatment. Drugs of the future, for example, first have to be discovered or created, purified, described, and tested in labs (in cell and animal studies) before ever reaching human clinical trials. Of all the substances that are tested in these early stages, very few are promising enough to be tested in humans.

On average, a new cancer drug has been studied for at least 6 years before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is how long it takes to complete clinical trials themselves. It takes an average of about 8 years from the time a cancer drug enters clinical trials until its approved.

Why so long? To be sure its safe and effective, researchers look at each new treatment in several different studies. Only certain people are eligible (meet the requirements) to take part in each clinical trial. And cancer clinical trials take years to complete. It takes months, if not years, to see if a cancer treatment works in any one person. And figuring out if a drug really improves survival can take a very long time."

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 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Oct 28 2019 at 7:41am
Originally posted by strongtogether strongtogether wrote:

https://www.forbes.com/sites/robinseatonjefferson/2019/10/11/mayo-breast-cancer-vaccine-could-be-available-in-less-than-a-decade/
It sounds like this vaccine can be used to stop recurrence. Has anyone seen this before? 


I read this article over the weekend and it helped remind me how many of the headlines we see about new treatments and cures may be over hyped. 

Behind the Hype: Breast Cancer Vaccine

Last week my email burst forth with this headline: Florida woman recovers from breast cancer with trial vaccine 

The article was about a woman named Lee Mercker who was treated in a clinical trial at the Mayo Clinic in Jacksonville, Florida, with an experimental breast cancer vaccine for women with early-stage breast cancer. The article reported that the vaccine had gotten rid of all of her cancer cells. Only later on do we read that she actually also had a double mastectomy. 

This type of hype is one of the problems with the breast cancer news we often see, especially in October aka Breast Cancer Awareness Month.  Its a shame because this research is really important.  

The researchers at the Mayo Clinic who are conducting this study are supported in part by the Artemis Project of the National Breast Cancer Coalition. They also are trying to develop a vaccine that will prevent breast cancer.  This type of work is complicated both because the immune system, the human breast, and cancer are all very complicated.  

Previously, the vaccine had been studied only in mice. This is the first time it is being studied in women. Early phase I studies are designed to see if a treatment is safe and what effect it has on cancer cells. The women enrolling in this trial are getting the vaccine before surgery so that the researchers can see the effect it has on their cancer cells. They are not receiving the vaccine as a breast cancer treatment.  

All the headlines I saw about this story would lead you to believe that the vaccine cured her breast cancer. That is not what happened. As the developer of the vaccine, Dr. Keith Knudson explained: We saw some evidence of elimination of the tumor, as well, as some evidence of the immune system crowding in. This does not mean the treatment cured her cancer.  

Now, the researchers will study the effect the vaccine has in two other patients they have enrolled in this study. They also are looking for more trial subjects. The fact that they saw an immune response is great! But it is way too soon for that type of headline!  

Susan Love, MD, MBA is the Chief Visionary Officer of the Dr. Susan Love Foundation for Breast Cancer Research. 

https://rsusanloveresearch.org/behind-the-hype-breast-cancer-vaccine/



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 sophie Quote  Post ReplyReply Direct Link To This Post Posted: Oct 29 2019 at 8:24am
anyone is doing immunization therapy for prevention?

Also, when shall we start taking xeloda after chemo? My chemo is over close to 1.4 months, my doctor still asking me to wait to take ... why?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote strongtogether Quote  Post ReplyReply Direct Link To This Post Posted: Oct 29 2019 at 4:34pm
Is Xeloda after therapy established as best practice? 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sophie Quote  Post ReplyReply Direct Link To This Post Posted: Oct 29 2019 at 7:57pm
good question. What are you taking now? Have you completed chemo yet?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote strongtogether Quote  Post ReplyReply Direct Link To This Post Posted: Oct 30 2019 at 1:46am
No, still on Taxol/carboplatin. 
After that its radiation therapy, and that's all.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sophie Quote  Post ReplyReply Direct Link To This Post Posted: Oct 30 2019 at 7:15pm
did you have sugery first?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote strongtogether Quote  Post ReplyReply Direct Link To This Post Posted: Oct 31 2019 at 12:29am
Yes Surgery first. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Kellyless Quote  Post ReplyReply Direct Link To This Post Posted: Oct 31 2019 at 12:54pm
Xeloda is mostly recommended for women that do neoadjuvant chemo and at surgery are found to have not obtained a PCR - they still have live cancer after chemo in their pathology. I've no idea how they ascertain if you should do it with surgery first. it's no small thing just because it's a pill and not IV, it comes with a list of side effects. Ask your medical oncologist for their opinion. You may also want to find out if your insurance will even pay for it if you had surgery first. 
IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/16 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Nov 12 2019 at 10:45pm

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy


Brief Summary:
This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC) patients following standard of care therapy. Patients with newly diagnosed clinical stage II-III TNBC are eligible for enrollment. Patients will receive standard of care therapy including chemotherapy, surgery and radiation therapy as clinically indicated. Following standard of care therapy, patients will be randomized to receive either a neoantigen DNA vaccine alone, or a neoantigen DNA vaccine + durvalumab.


Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Triple Negative Breast Neoplasms TNBC - Triple-Negative Breast Cancer Triple-negative Breast Carcinoma

Drug: Durvalumab Biological: Neoantigen DNA vaccine Device: TDS-IM system (Inchor Medical Systems) Procedure: Peripheral blood draw Phase

1








Edited by 123Donna - Nov 12 2019 at 10:47pm
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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