Tykerb - TEACH TRIAL
 

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

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

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

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

Keep Trying, Joanie
 

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

I'm in the trial, too
 

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

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

Joannie,

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

Regards
Joe

Joannie,

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

Regards
Joe

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

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

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

TEACH Trial
 

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.

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

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!!

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

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

Take care,
Joannie

Joannie, keeping my fingers crossed for you!

<3 Lolly

Accepted into the Trial
 

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

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.

I received the pills today. I will be taking 6 pills a day for one year. I was instructed to take them 1 hour before/after a meal, at the same time each day. Does anyone have any suggestions for a good time to take them? I am planning on before bedtime. Wish me luck!

Joannie

Hi Joanie,

Are these pills 250 mg each. Are you having it with Xeloda or alone.
I thought the recommended dosage was 1250 mg which would mean 5 pills if each pill was 250 mg

Hi Rupali,

For the TEACH trial you take 1500mg (6 pills) once a day and take it alone.

Pat

Well, I have completed 15 days so far of the Tykerb pill. I believe that I have received the "real" thing. I had terrible stomach cramps on day 2 and 3 and by day 4 I had mouth sores, which fortunately, subsided quickly. Feeling fairly well after the initial onset of diarhea, but am not dealing with tingling in the hands and my face and chest is quite broken out with what seems like teenage acne. I have read that diarhea, mouth sores, and tingling are all possible side effects of Tykerb, but I have read nothing about the acne. What is the rash like that can be associated with taking this drug? Has anyone else had this acne like reaction? I never, ever have acne issues, so I'm guessing something is going on. The diarhea comes and goes. I don't have to deal with it on a daily basis. At any rate, I'm greatful to be in this trial.

Joannie

second day on tykerb
 

I just started tykerb for her2 Neu+, Er+ breast cancer that has progressed with a 3cm liver tumor despite treatment with Herceptin, abraxane, xeloda , zometa and faslodex. I was first diagnosed in June 2002 with multiple mets in my liver and bones. I experienced diarrhea with tykerb. I needed 4 imodium tablets. My question does the diarrhea get better with time?

Decided not to participate in Tykerb/Herceptin/Taxol study
 

Just read your reflections on the side effects of Tykerb. I was diagnosed with a 1.3 tumor (encapsulated) on August 1, 2007 and had a double mastectomy on October 4, 2007. The findings were that I had NO lymph node involvement but the tumor was 2.3 by the time they got it but encapsulated.. I had immediate reconstruction (DIEP) on October 4, 2007I and healed for 6 weeks before starting Adriomiacin with Cyclophosphomide chemotherapy from November to the end of January and am now taking weekly Taxol with Herceptin chemotherapy until the end of May. I lost 45 lbs. with the first cylce of Chemotherapy and was just too scared that I would not be able to handle the side effects of the Typerb.

I was given 30 Tykerb tablets, got the first 4 out and just couldn't take them.
This is all still so scary to me and "new" that I still can't believe it's happening.
You both are so brave to take the tykerb; I really admire you. Any advice for a person who is total shock and fear? Thanks for your thoughts and advice.

Bless you both,
SherryG

SherryG:
I too was nervous taking Tykerb. The unknown of what the drug can do is sometimes overwhelming. Since I never received Herceptin, I really was greatful to get the opportunity to try Tykerb. I have to say, for me, I have tolerated it quite well. The diarrhea was the worst side effect. Lasted for 3 months, but not so bad that I even had to take an meds. After 3 months, it has subsided and I only get bouts of diarrhea maybe once every 6 weeks. I think something I eat may set it off. I do get echo cardiograms every 3 months through the trial to monitor my heart. So far, so good. I am on my last three months of Tykerb. My trial will end in April. Compared to standard treatment, this drug has been a piece of cake for me. I pray that this trial will have positive outcome and it can help many women in the future. If you have any other specific questions, please let me know. I have had many side effects, but most were short lived and quite tolerable. Good luck to you and I'm here if you need more info.
Joannie

Thanks for the response Joannie
 

Joannie, Thank you so much for your words of wisdom. I am still trying to deal with the reality of having Her2+ and it's just not getting any better as to how in the world I got this. Anyway, I will pray for your continued good news and experiences with Lapadinib. I decided not to take it or be part of the study; I pray it was the right decision. I will have Taxol and Herceptin infusions each week until the end of April, first week of May and then will have Herceptin infusions every three weeks until February of 2009. Take care...and thanks again.

Hi all - I have been on Tykerb/Xeloda for 11 months. For me it has been tremendously tolerable. I have had the rare bout of diarrhea, (maybe only 4 bouts of 2 days each over the entire 11 months) but never anymore. It was more possible/noticeable when I didn't eat a really clean, smart diet. The junkier my food, the more the chance of diarrhea. The cleaner and more whole and smart my diet is, I have virtually no problem at all! I highly recommend really looking at eating habits as a good start to mitigate diarrhea.

Other than that, I have experienced Tykerb as an amazing cancer fighting tool that is tremendously tolerable! Just more info and real life experience for you to consider as you make decisions...

Hope it helps.

Has anyone with HER2 positive breast cancer not had it return. Does anyone know?

I'm going through 15 months of treatment and just need to see who knows some facts out there rather than hearing from doctors, "If you do everything, you have a 90% chance of it not returning for 10 years." Is that the case with the women you all have been in contact with?
Trying to find answers and peace,
SherryG

Joanie,
I went on the HER2 Sisterhood site and read about the success or limited success of Herceptin with stopping the cancer from re-occurring. I'm really worried this will kill me.
The only reason I didn't take the Tykerb was the worry of the side effects because I've lost so much weight and didn't feel I had any weight to lose before the condition would have been medically serious. How long and how often did you have diarrhea? The acne-like rash...what was that? I'm now thinking the cancer will return no matter what I do. I need your thoughts because you've been taking the Tykerb. Thank you ahead of time for your help.

Trying to find answers,
SherryG

SheryG:
I have been on the TEACH Trial since May of 2007. The diarrhea was pretty constant in the beginning, but never so bad that I had to take any meds to stop it. It was on and off over a 3 month period and has mostly subsided. It flares up from time to time, probably due to something I have eaten. The acne like situation was quite bad in the beginning. My entire face was broken out. I was on the verge of asking for meds to get it to settle down and then it subsided. I have had other minimal side effects, mostly in the beginning but they were all short lived. So far, so good for me on this trial. Compared to the standard treatment of A/C and Taxol, this has been a breeze for me. I have tolerated it well. I too worry about reoccurance, that is why I pursued this trial. I was unable to get Herceptin because it was approved after I completed all of my treatment. I never felt at east not getting the Herceptin. It has been successful for so many. I have gotten some piece of mind taking the Tykerb and feel more at ease that I have done everything I can. I am coming up on five years in April of my diagnosis. In the beginning, I never thought I woud see 5 years, but each year I gain more confidence that mets is not always inevitable. I have learned so very much from this website and I am greatful for all the information available here. If you have any additional questions, please let me know.