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!

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

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

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

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.

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