New breast cancer vaccine provides evidence of immunotherapy in preventing disease re

News · 09-08-2014, 06:50 AM

A new breast cancer vaccine candidate, (GP2), provides further evidence of the potential of immunotherapy in preventing disease recurrence. This is especially the case for high-risk patients when it is combined with a powerful immunotherapy drug.

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'lizbeth · 09-08-2014, 01:58 PM

I liked this line:

Quote:

Women with HER2 +3 who were administered trastuzumab as part of the standard of care prior to receiving the vaccine experienced no cases of cancer recurrence.

So ladies, are we looking at high cure rates with these vaccines? It appears so. Not only the early stage Her2 3+ with GP2, but the subset of triple negative with low Her2 expression might also reach high cure rates with the E75. I expect good news from AE37 as well.

We lucky ladies who entered these trials need to stay in touch with the trial administrators. I personally would like to see data beyond 5 years.

'lizbeth · 09-08-2014, 04:24 PM

I checked the dates for the phase II, both AE37 & GP2:

Estimated Enrollment: 600 Study Start Date: January 2007 Estimated Study Completion Date: December 2015 Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
I'm only familiar with E75 being in Phase III. If anyone gets news about a Phase III for AE37 or GP2 please share.

europa · 09-08-2014, 07:21 PM

I am in the phase 2 of the GP2 vaccine trial from Walter reed. I know they reached their enrollment goal and my admin nurse said she is waiting to hear in phase 3 will begin soon. I was HER2+ (+3), so this news is amazing and I am so glad I did the trial.

'lizbeth · 09-08-2014, 11:39 PM

I'm 3 years ahead of you in the trial.

I had hoped that the Phase III for AE37 & GP2 would have started earlier so that more of us could have enrolled, especially with such good news. I will be so flippin relieved when the Phase III starts - I expect and hope the vaccines will be available in numerous, more accessible trial locations.

Shirley · 09-09-2014, 11:06 AM

This is indeed exciting news; I wish I could have been on the trial.

So what is the Phase III part of a trial? Will they enroll new patients or just continue following the original cohort?

Also, 'Lizbeth, do you know if the vaccines have to be administered within a certain length of time after completing treatment with Herceptin? I'm just wondering if this will impact those of us who finished treatment already.

Shirley

'lizbeth · 09-09-2014, 11:10 AM

Shirley, to answer part of your question. This is the reason for the different Phases of a clinical trial:

Quote:

ClinicalTrials.gov - Clinical Trial Phases

Question: What are clinical trial phases? Answer:
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources

Shirley · 09-09-2014, 11:21 AM

Thank you!

'lizbeth · 09-09-2014, 11:27 AM

If we are fortunate enough to have a Phase III trial for the Her2 higher expressors it will be with all new enrollees. I hope that we Phase IIs will continue to be followed.

When I enrolled in the Phase II, I had expected a Phase III to start for the Her2 survivors. Along the way, the primary companies switched focus from us to the lower expressors. There are Phase III trials currently for Her2 1+ and Her2 2+, but nothing for the Her2 3+ that I am aware of.

I thought that Dr. Mittendorf was working on something for the higher expressors with E75, and I hope so. I would also like to see Antigen Express start a Phase III for the higher expressors with AE37, and Dr. Peoples with GP2.

When I enrolled in the AE37/GP2 trial the window was to be enrolled 6 months from the completion of Herceptin.