I'm in the TAILORx trial. anyone else?

Raili · April 2013

I'm super annoyed.

Almost 3 years ago, I enrolled in the TAILORx trial, which is designed to compare the outcomes of chemo-plus-tamoxifen with tamoxifen-only. I signed a bunch of paperwork and they took a couple vials of my blood. But since then, NO ONE has followed up with me or monitored my compliance with Tamoxifen or mentioned the clinical trial in any way. I've switched oncologists twice (for unrelated reasons), and last year, I stopped taking Tamoxifen for four months. I assumed this would automatically get me kicked out of the clinical trial. But NOPE, I read the note my oncologist wrote about our most recent visit, and it says that I'm enrolled in the TAILORx trial. So I just called the oncology dept. that signed me up for this nearly 3 years ago, and asked to speak with whoever is in charge of it so I can make sure I was unenrolled - since I was noncompliant with treatment - and they were like, "Um, I don't know anything about this; we're training a new person and will have to call you back." [Edited to add: it's possible that I WAS taken out of the trial, and my current onc just didn't know that, and wrote "currently enrolled in TAILORx" in my chart by mistake. I'll keep you updated. If I WAS unenrolled, I think I should have received notification of that.]

This is totally causing me to lose faith in the validity of clinical trials in general. I can't believe no one's monitoring me, and no one took me out of the clinical trial when I stopped taking the medication that the clinical trial is testing, for four months. We are all prescribed medications based on the results of previous clinical trials. I now don't trust those clinical trials. How can we trust that 5 years of Tamoxifen is really what benefits us the most, if women in previous clinical trials may have, like me, stopped taking it for months without anyone knowing or caring? UUGGGHHHHH.

Is anyone else in the TAILORx trial, or a different one? Are YOU monitored more than I am?? I sure hope so.

Golden01 · April 2013

I am not in TAILORx but wish the results had been available back when I was diagnosed in 2011! My Oncotype was in the Intermediate score range so decisions were difficult.

I am enrolled in the University of Arizona "DIME" study evaluating the active substance in broccoli in for women with early stage breast cancer who are on Tamoxifen. The first visit was very detailed and they went over the exact schedule for visits, blood work, assessments etc. Then they had me do a two-week "trial" with placebo where I needed to do record keeping. My next visit was a month after the first. My schedule of visits is nine appointments over an 18 month period with visits closer together in the beginning. They also offered another part of the study that included a breast MRI. As I had a BMX, I declined. In between visits, the research nurse calls and/or e-mails me at specific intervals. At each visit, they carefully review all forms and documents (line by line) to be sure I've filled them out completely and ask follow-up questions. Each visit also includes a review of what's needed throughout the remainder of the study. They gave me a tote bag to carry my medicine and papers in, a pill box to keep track of my medications, and folders to store the papers with all the info on the study. They are always available by phone and e-mail if I have any questions and usually answer the same day but always by the next.

I'm sure every study is different but I am confident the Principal Investigator for your study can sort out what is happening for you. That name along with what was is scheduled throughout the study would be included in the consent you originally signed. If you don't have that from three years ago, the study could provide you a copy. Good luck tracking down what has happened. Keep us posted as you learn more.

Is there a chance that the study involves reviewing records from your oncologist rather than directly from you?

I'm in the TAILORx trial. anyone else?

Comments

Categories