HER2 Support Group Forums

HER2 Support Group Forums (https://her2support.org/vbulletin/index.php)

- her2group (https://her2support.org/vbulletin/forumdisplay.php?f=28)

- - Puzzled?? (https://her2support.org/vbulletin/showthread.php?t=64373)

I am confused as to why I appear to be ineligible for any of the vaccine trials that are available. I am currently continuing Herceptin treatment every 3 wks and have been for almost 6 years since a recurrence 3.5 years after my original diagnosis. I live in the Seattle area and there are a number of vaccine trials going on but I am considered ineligible because I don't have active cancer or am continuing Herceptin . This doesn't really make any sense to me. For those of you who have participated in a vaccine program, can you help clear up my confusion? Thank you.

I had to take a break from my herceptin treatments in order to do my trial. I think I was off for about 5 months, then went back on when trial was completed.

Thanks for the response Larish. I notice that most of the trials at the UW are for our stage IV sisters which I TOTALLY support. God knows they are in the most need of immediate help. I guess I'm just a little surprised that since vaccines have been around for quite some time now, there aren't some that are standard treatment. Guess that will come in time.

Lauriesh, sorry I misspelled your name on the previous post.

They aren't standard treatment because they have not been successful enough. They started with the original vaccine, but it didn't produce enough of an immune response, so then they started trying adding in other drugs to boost it.
When I did my trial, they added in, I think it was called ampligen. This was not successful, as a whole, even though I think it was for me, as I have been Ned from liver mets for almost 5 years. Now, I see they are adding in a mushroom tea. Hopefully, they will find the right combination that produces good enough results to start more widespread testing.

That is called politics. I just posted about it on the Dr Susan J Love facebook page about this yesterday, let me repost:

The sad things are that immunotherapy researchers have been working without a lot of professional support for the past thirty years, even as now they are suddenly in the spotlight and it might be the way out of this dreadful disease.

What is worse is to know that there are breast cancer vaccines that are shelf-stable, with proven safety profiles that have been studied for years in patients, with efficacy rates including up to 40% durable responses -- and yet the powers-that-be require that additional studies be conducted.

Someone else decided that the end-game is to develop a breast cancer vaccine that could be given to the larger population against developing breast cancer and yet meanwhile, patients who are able to get their disease burden low may still progress and die because 40% against one breast cancer type isn't enough in someone else's book.

Tell me a single woman with breast cancer who wouldn't rather take a 40% chance than do nothing, the current standard of care.

---

Breast cancer immunotherapy works best when:

The tumor burden is low, so NED or stable bone mets

If the cancer is active the immune system is pre-occupied by the cancer which confounds your immune system.

They can teach through the vaccines to have your body overcome cancer's immunological evasiveness, so one's body will be able to attack mutant cells should they start to form again. But to teach it things have to be quieter in the patient's body.

---

"New breast cancer vaccine ‘promising but not ready for prime time'."

No, it’s plenty ready.

https://t.co/WEl7nYVfIV

---

This is about Carter's treatment not specifically breast cancer vaccines but it is a great overview about cancer immunotherapy in general.

http://www.onclive.com/web-exclusive...rapy-in-cancer

I agree that trial eligibility both for vaccines and in general can be confusing. There are many reasons for this. For example, usually the early trials (stage I and sometimes II) are designed more to look at best dose, and safety (rather than efficacy). They are designed to get results quickly, so that if things are looking good, they can move fast to the stage III trials (which enroll more patients and can lead to the agent's approval). In order to get those quick results, they need to monitor measurable disease. Trials in an NED setting (whether after primary tx or for stage IV) have to follow patients much longer, which means more expense and more delay in getting the drug approved.

Trials also can be restrictive because we know that by limiting enrollment to cancers with a specific target (or, in the case of vaccines, certain details of the person's immune system like HLA type), they can get a higher percentage of responses. From a business standpoint (which, whether we like it or not, is the bottom line for Pharma), there is a push-pull here. Finding an agent that is highly active for a tiny segment of cancers means that the company will have only a small market for that agent. The book "The Philadelphia Chromosome" by Jessica Wapner is an interesting read about the challenges of developing a drug for a small market (and touches on many other interesting aspects and frustrations of drug development). The wider the net, the larger the market will be (if the agent is successful). But if the trial design spreads the net too wide, they risk having a negative trial, even though within the large group there may be subgroups with positive results (that they couldn't see because they didn't look).

Like most of us, I'm excited by the progress that has been made with immune therapy for cancer, but that is somewhat dampened by the fact that at least so far, we just don't know enough. Immune function is incredibly complex, and each step forward in knowledge gained also results in more questions and more awareness of the complexity. There have been so many trials that were "positive" in terms of measured immune responses but that did not result in clinical responses. In addition, it's early days as far as discovering the downsides (side effects) of tinkering with immune functions.

It's so hard to be patient with the slow process of drug or vaccine discovery. Some of the slowness could be remedied with better trial design and attention to the incredible barriers of the red tape (both within the FDA and the drug corporations). But much of the slowness, though frustrating, comes out of concern for safety. We can cite examples of agents that turned out to be wildly successful (Herceptin would be one), and say that they should have been approved sooner, and could have saved more lives. But for every success, there are also stories of failures -- of treatments that looked good initially but turned out to have major flaws (toxicities, lack of efficacy). The "gold standard" cautionary tale in that regard is bone marrow transplants for breast cancer. The book "False Hope" by Richard Rettig tells that story well, and gives an idea of the challenges, in general, of getting a treatment to market.

I know this doesn't really answer your questions, nor help with our frustration at the slowness. Especially in the short term, there is not much we can do. But advocates at the tables (trial design, drug development, research grants) can help bring that needed sense of urgency. In the last 10-20 years, the value of advocacy has been increasingly recognized, and the opportunities for both education and participation have grown. There are many programs to educate advocates in both the science and the research process. I encourage everyone to take advantage of the educational programs and become active advocates. I think I'll start a new thread where we can list ways that we are aware of, for patients to educate themselves, join with other advocates, and make a difference.

Debbie Laxague

I haven't been able to find a vaccine trial. What key words do you use in the search box. I'm stage IV

Dakini52 I recently applied to a vaccine trial and was rejected. The problem stemmed from my HER2 copies per cell being too high? I was told they were looking for a 3 or below when my copies per cell are 28+; this struck me as odd because it is a vaccine trial for HER2 patients and as we all know HER2 copies per cell vary widely in our personal pathology reports. I discussed it with my oncologist and she said she did not understand why the HER2 copies per cell would be a determining factor. I also believe that being stage IV put me past the level patient they are looking for which is stage 3 or less. It was an interesting process; didn't know you got paid to do clinical trials.

Thanks everyone for your responses. Valley Girl - Here are the links I use when searching for trials:

https://www.breastcancertrials.org/b...al_PostalCode=

http://www.cancer.gov/about-cancer/t...thprofessional

I will just keep up to date on the status of vaccines and hopefully they will become more widely approved for use.