Menopause - prerequisite for vaccine trial?

[*_Julie_*]

I came to know that one of the eligibility criteria to recieve the vaccine in UW clinical trial is to be permanant menopausal. Which I feel is very unfortunate for the young woman with BC. Anybody is aware of any other vaccine clinical trial where menopause is not a condition?

Thanks!

[al]

That is news to me! Where did you get that information?
Al

[Lolly]

Julie and Al, I am not aware that it's a pre-requisite for the Her2 Vaccine/Herceptin trial as it's not listed in the criteria for eligibility...however, I do happen to be menopausal, since '96, and when my medical history they asked specifically if I was menopausal and for how long. I'll ask at the next visit if it is indeed a criteria, or if anyone needs to know sooner contact Patty Fintak:

Patricia Fintak, Study Research Nurse
(206) 543-6620

Hope we can clear this up.

Love, Lolly

[Kim in DC]

That doesn't sound correct. Maybe you are confusing it with the fact that you have to sign a waiver and agree not to get pregnant while on the trial. The trial in PA did not list any stipulations about pre or postmenopausal.

Kim

[*_Julie_*]

Actually I got this information when I talked to one of the coordinators of the vaccine trial in UW. I am talking about the herceptin DNA vaccine trial for stage3. They asked me to get the blood tested for permanant menopausal.

[Lolly]

Ok, that explains it...The study I'm in, which is the Her2 CTL peptide based vaccine in conjunction with Herceptin for Stage 4, stipulates that:

"...If you are a man or a woman who is able to have children, you should be done with child-bearing and must agree to use an adequate form of birth control during study participation. Women should continue adequate birth control until they are menapausal...If you are a woman who is able to have children, you will be given a pregnancy test before you begin the study to make sure that you are not pregnant..."

This is quoted directly from the consent form I signed, but I kind of forgot about it as it didn't apply to me. Hope this helps clear up the issue.

Love, Lolly