I Didn't Get T-DM1

[KDR]

Well, after going through all the prerequisites for the Emilia trial, I was randomized to the standard of care. I want to thank everyone for checking up on me during this period of no news. Today marks my 26th day without treatment, and that is more concerning to me at this point.

I know I am in good hands, and in God's hands, so I'm looking in the other direction and stepping...forward.

Karen

[Jackie07]

How dissapointing!

What is the standard of care? Is it Taxol/Herceptin that you've used before?

Sending you good vibes.

[chrisy]

I've been wondering but didn't want to intrude. Yes, "worst case" is now you are getting standard of care. I assume you are still technically on study, so will still get benefit of close monitoring.

You are right, you are safely in God's hands and exactly where you are meant to be -even if you don't understand yet how that will unfold.

Much love
Chris

Ps for once the stupid iPhone autocorrect did good-it typed much live which is also appropriate!

[Catherine]

Karen,

Hugs, love and support from me.

[ElaineM]

I am sorry you didn't get T DM1, but you will be closely monitored which is good. You can also withdraw from the trial if you find something better.
I think the standard of care for the Emila trial is Tykerb and Xeloda according to what I read on the clinicaltrials.gov website.
Take good care of yourself.

[radiant]

I know how disappointing that must feel. On the plus side, you will get scanned in 6 weeks - that's good. I believe if x&t don't work, you then can get extended access tdm-1, right?

Kim - so another way of looking at it is maybe you are 6 weeks away from tdm-1. fingers crossed.

[michka]

Karen, I can imagine how much you are disappointed. I was hoping so much you would be in the TDM1 arm. Not because Tykerb/Xeloda may not work but because it is what you were fighting for. Now isn't T/X what your first oncologist suggested? Are you going back to him or are you staying in the trial? What happens in the trial if they see that T/X is not working? Do they switch you to TDM1? I hope you have this all figured out now and that you can start another treatment. You will feel better if you know you are hitting the stupid mets. I am sending you hugs and strength. Michka

[KDR]

Hi! I'm good with it. I went to another facility because my usual hospital's T-DM1 trial is closed. I like the onco at the "new" facility, but not much else. I don't plan to stay in the study because yes, it is Tykerb & Xeloda, but I don't want to be so governed that my doctor and I couldn't add something if we thought it would be beneficial. I would not be able to switch over to the study drug if progression occurred. They made that clear. So today, I will discuss with my oncologist the new regimen I should start. Navelbine has been brought up, too. As for the T-DM1, who knows why I randomized to the study...it's all unknown. I look at it this way: it may not have been MY miracle drug. So on we go.
Love to all, Karen

[KDR]

Yes, Jackie, I did Taxol/Herceptin. I got me to NED in six months, then I had some progression in liver only. Other spots remain inactive.
Karen

[Chelee]

Karen,
I am so sorry you didn't get the T-DM1 like you had hoped too. Quite a while ago I went to two different places and was offered this same trial. I let both places know my only interest was T-DM1. I was willing to drive to these other cancer centers for the TDM1...but like you If I did get placed on the T/X arm of the trial there would be no reason to drive that far for those drugs. I can get them at my cancer center. So I can just imagine how disappointed you are.

I didn't like the idea I'd be off Herceptin too if I got the T/X side. Then the deal breaker for me was if I was lucky enough to get placed on T-DM1 and it did not work for me there is was no cross- over. Most trials you can always cross over if there is progression.

So are you going to try the Tykerb/Xeloda at your center, or look into other options? I know your main concern must be waiting for the wash-out period to be over. I'm sure your anxious to get started on something. You have lots of options left and I know your onc will find something that works well for you. Hang in there. Keep us updated.

Chelee

[michka]

I understand your thinking.Why stay in the trial if they don't switch you to TDM1 in case T/X doesn't work and if you loose flexibility. There are other options. I am sure they will work for you. I am just sorry they are not speeding up TDM1 availability. Michka

[KDR]

If T/X don't work, I'm out of the trial. Plus, I want to go back to my usual facility, where I feel at "home," if home is a word for a cancer center!
Did anyone add Herceptin to this mix? My onco said that combo is a "rough" road, but one of my special friends on this list is doing it, and she's a warrior!

OK, so what does everyone think blasts liver mets the fastest?

Karen

[ElaineM]

Going back to your original cancer center is a great idea, because even if you try Xeloda and Tykerb there you have more flexibility of trying other things with that combo or switching to another combo quickly if that combo doesn't work. Trials have alot of rules.
You can always keep looking for a T DM1 expanded access trial or keep your fingers crossed like the rest of us that T DM1 will be approved by the FDA sooner rather than later. It will be available to almost everyone who needs it after it is approved. I heard the drug company is planning to reapply to the FDA sometime in 2012.
Is there someone at your medical center who you can talk to about Milk Thistle by itself or Milk Thistle in combo with dandelion and/or artichoke. All are supposed to be good for the liver.
I have taken milk thistle everyday since my diagnosis and never had a liver met or abnormal liver enzymes.

[krisvell]

Karen,
Rats, rats, rats. I was hoping you'd get the TDM1. Yes, you are in good hands (God). I pray your oncologist and you quickly come up with your new treatment and it knocks the heck out of the mets; kinda like a grand slam -- out of the park!!
Hugs and Love,
Kris.....

[Ellie F]

Sorry to hear this Karen.We are all praying that T-DM1 will soon be available for all (including us across the pond). I know you must feel disheartened but there will be a way forward that will arrive.
Ellie

[Elizabethtx]

I know this is not the news you hoped for....but all for a reason I always believe. I will be hoping and praying that a path is clear for the next step!
Hugs,
Elizabeth

[radiant]

Wow Karen - can't believe they won't let you take tdm-1 if you wanted to. You totally made the right decision to ditch. I turned down this study as well as I was freaked out about the high dosage of x and t req'd. Now, I am sooooooo glad I did that. x and t did nothing for me, but if it would jeopardize getting tdm-1 eap - screw that.

thanks for the update -

Kim

[schoonder]

"if it would jeopardize getting tdm-1 eap - screw that"

Instead of "jeopardize" participants in non-experimental arm of trial should if medication doesn't/no longer provide efficacy be given option to receive new drug at same location, although now no longer enrolled in trial. It would expedite enrollment cycle, thus making for potentially speedier trial and give measure of appreciation to participants for putting up with additional hardships (time, cost, travel, frequency of exams etc.) associated with signing on.

[KDR]

I am now on Tykerb/Xeloda/Herceptin. Looked into Navelbine, but I don't have a port. After speaking with my onco and nurses and others about it, I feel I'm going to do well on it. As for the side effects, my hospital is ready for any and all. They can always adjust the dosages. Come on, cure!

I also believe that T-DM1 was not for me, right now. I don't quite understand (or maybe believe) how the "randomization" process works in trials, but I'm on a new path and hopefully I will have the same response to my current regimen that I had in the first.

Thank you, everyone, for your insight.
Always,
Karen

[Sheila]

Karen
Your attitude in this post says it all....looking forward with positivity....we are with you! As always, on the hunt for NED!

[Joan M]

Karen,

I'm sorry about the trial, but we never know how other drugs might work. Many women have become NED, and before T-DM1. Kudos to you for checking out the options and following through!

Joan

[schoonder]

"I would not be able to switch over to the study drug if progression occurred. They made that clear."

Wonder if all site investigators are going by the same "game-book", reason being, in waterdreamer's "TDM-1 side effects" post she indicates that after progression on standard treatment she was switched to experimental (t-dm1) arm of trial.