Tykerb - TEACH TRIAL

Joannie · 04-22-2007, 03:54 PM

Good Evening All:
I'm one of the gals that never received Herceptin, due to it being approved after my chemo treatment was completed. I was diagnosed in 2003. I've been looking into the TEACH trial here in Ohio, which is Tykerb. Unfortunately, I have made many phone calls to the 1-888 number and no one ever returns my call. My onc. doesn't believe this if for me and didn't believe in Herceptin for me because I was too far past treatment.
I just can never seem to let this area rest. I just came up on my 4 year mark of being diagnosed and I'm currently NED, as far as I know. It pains me to read on this board all the women getting Herceptin as a preventative. I'm so happy the drug is available but can't help but feel I missed the boat. Can anyone provide information about whether I should pursue the Tykerb? I was stage 2, HER2 3+, 3.3 cm tumor, 1 node positive. I had a double mastectomy, no rads.
I would appreciate any information you could provide.
Thanks and I pray for everyone on this site so often. You are all an inspiration to myself and many others.
Thank you!
Joannie Willhite

AlaskaAngel · 04-22-2007, 04:45 PM

Hi Joanie,

I'm not sure where the 888 number you are using is from... but here are the Ohio sites and numbers:

United States, Ohio
GSK Clinical Trials Call Center, Canton, Ohio, 44718, United States; Terminated

GSK Clinical Trials Call Center, Columbus, Ohio, 43215, United States; Not yet recruiting
Philip Kuebler 877-379-3718

GSK Clinical Trials Call Center, Middletown, Ohio, 45042, United States; Recruiting
Nandagopal Vrindavanam 877-379-3718

GSK Clinical Trials Call Center, Cleveland, Ohio, 44106, United States; Not yet recruiting
Paula Silverman 877-379-3718

GSK Clinical Trials Call Center, Cleveland, Ohio, 44195, United States; Not yet recruiting
George Budd 877-379-3718

I think you would be one of the more important candidates for the trial.

This is the trial info:

http://www.clinicaltrials.gov/ct/show/NCT00374322

Please post if you have other questions.

AlaskaAngel

PatS · 04-22-2007, 04:45 PM

Hi Joannie -

I am currently participating in the TEACH trial. I'm am in the same position as you; I was diag. Stage 3 in July 2002 and finished chemo in Jan. 2003. My onc. also didn't believe herceptin would be beneficial as it was approved too long after my chemo ended. I believe I was told this trial was for those who ended treatment 8 years or less ago. Did your onc. say why he didn't think it was for you? Is he participating in the trial? If not maybe you could find another onc. who was.

Pat

Joannie · 04-23-2007, 06:37 AM

Alaska Angel:

Those were the actual numbers that I called. I just pulled the number from the top of my head! I have called several times and got a return phone call once. They left a message to call back. As you know, you only get a recorded voice to leave a message. I was hoping that my onc. would hook me up, but she said the trial is only for mets.
I guess I'll try to call again.

Pat, how well are you tolerating the drug? How far out are you from chemo?
Thanks for the input.
Joannie

AlaskaAngel · 04-23-2007, 10:23 AM

Joannie,

Your onc is not correct in regard to the TEACH trial. It is designed for those who have had Adriamycin, have no evidence of recurrence, and who have never had Herceptin. Even those who are just finished with chemo now are eligible. The only disadvantage they would have is that anyone in the trial can end up on placebo instead of the lapatinib.

I'm not sure why so many sites in your state are either not yet open or not going to be. Although some sites opened as early as December, the site where I inquired didn't open until March.

Try calling the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) and speak with an Information Specialist about it, and also give your onc a copy of the clinical trial announcement.

AlaskaAngel

bashmaz · 04-23-2007, 10:45 AM

Hi all - I'm also in the trial for those out from chemo, no Herceptin, no recurrance. (Hi to PatS and AA!)

I had lumpectomy 4/2002, AC, Taxol, Rads. 1.8cm tumor, 1+v node, ER/PR-ve, Her2+++.

My Oncologist's group is the main place in my area (SW Washington State, across the river from Portland, OR) recruiting for this trial, so he actually brought it up to me. I've been on it since Feb, and I'm having my second Echo tomorrow.

I'm pretty sure I'm on the placebo - I've had absolutley NO side effects. When I see my onc. next week, I'm asking if they have anyone else on this and if they have had side effects. So far, those they know on it are also on xeloda, or another drug as well bacause they have mets.

I'm doing well - so if it's the real thing or not, I'm still happy to be participating.

Marianne

PatS · 04-23-2007, 05:51 PM

Joannie,

Your onc must not be aware of this trial, maybe she's getting it mixed up with the fact that the FDA approval was for Tykerb plus Xeloda. At any rate, she's wrong about this trial as you can't participate in this particular trial if you have mets. Maybe you could print out the info from the link AlaskaAngel posted. It clearly states there that it is not for mets patients. Like Marianne, I am not experiencing any side effects I can attribute to the drug so I am probably getting the placebo also. I have been having problem since starting it with my nose, it's extremely dry and cracks inside, but that probably has more to do with the cold weather and dry air in the house. Good luck....keep trying.

Marianne,

Let us know how your echo goes and what your onc says.

Take care,
Pat

Joe · 04-23-2007, 06:30 PM

Joannie,

We have forwarded your post to our contact at GSK. You should be hearing from them shortly.

Regards
Joe

Joe · 04-24-2007, 03:23 PM

Joannie,

GSK has responded to my inquiry. I have emailed the info to you.

Regards
Joe

Joannie · 04-24-2007, 04:15 PM

Thanks Joe for taking that extra step. Ironically, I left yet another message yesteday with the number that I've been calling for quite some time. I received a call from them first thing this a.m. I called the Middletown Ohio number directly and they set up an appt. to speak with the onc. and the Dr. running the trial. My appt. is next Wed. I'm very excited to at least learn about the trial and see if I might be eligible.

Thanks again for you you do. This web site offers so much value to everyone who uses it. Words can't express how greatful I am to have such a resource to help us all along this difficult journey.
Truly,
Joannie

Barbara2 · 04-24-2007, 07:43 PM

Joannie, I believe there is a trial going on right now for those who didn't get herceptin. Is anyone aware of this??

Joannie · 04-25-2007, 11:53 AM

Barbara:

I checked into a trial out in CA, specifically for ladies who never received Herceptin. I believe the criteria was you had to have been diagnosed in the year 2004 and later. I was diagnosed in 2003. I spoke to her in detail about the trial and she in fact mentioned the TEACH Trial. Are there any other Herceptin trials that you are aware of that I might be eligible for? How do we know which is better at this point, Herceptin or Tykerb. I guess that is the million $ question!
Thoughts?
Joannie

Joannie · 05-02-2007, 06:12 PM

I had my appt. today with the clincial trial doctor for the TEACH Trial. He was very informative, but I have to say from all the reading I've done on this website, there wasn't much I didn't know about! At any rate, I signed the consent form and hopefully I will know if I qualify over the next couple of days. I'm pretty confident that I'm making the right decision. It seems that there are a lot of positives about Tykerb. I'll keep you posted.

PatS · 05-02-2007, 08:15 PM

That's good news Joannie, I'm glad the appt. went well. Let us know how you're doing. I'll be interested to see if you have any side effects. Did the onc. mention anything about the side effects his other patients in the trial are experiencing?

Pat

hutchibk · 05-02-2007, 10:15 PM

Joannie - it sounds like the answer to your million $ question might be in the mouse research at Baylor College of Medicine in Houston - where they are getting cures on mice with the combo of Herceptin/Iressa/pertuzumab...

We'll have to wait and see, but I hope they hurry!!

Joannie · 05-10-2007, 01:41 PM

I spent the day going through all the testing to see if I qualify for the Tykerb TEACH Trial. I am keeping my fingers crossed! They took about 6-7 viles of blood, EKG and and echo. Also a urine sample. They said I should know something by the first part of next week and if approved, I will start the trial by the end of the week. They seem to want to get me going right away. I am praying to get the real drug and not the placebo since I've never received Herceptin. I'll keep you all posted!

Joannie

PatS · 05-10-2007, 08:01 PM

Good news Joannie, I hope everything goes smoothly. Keep us posted.

Take care,
Joannie

Lolly · 05-10-2007, 08:24 PM

Joannie, keeping my fingers crossed for you!

<3 Lolly

Joannie · 05-16-2007, 09:26 AM

I just received a call from the clinic who is doing the TEACH Trial. All my tests came back good and I'm going tomorrow to get the pills to begin the trial. God willing, it will be the "real" thing. Thanks for all of your help and insight on this matter. I may have not gotten Herceptin, but by entering this trial, I feel like I'm somehow contributing to getting rid of this awful disease.
I'll keep you posted. Those who are on Tykerb alone, do you definately have side affects? Will I know if I'm actually on Tykerb vs. the placebo? Just curious what to expect.
Joannie

Rupali · 05-17-2007, 11:33 AM

Does anyone have the details of the Teach Trial. By details I mean how much Tykerb per day the active arm gets and for how many days etc.