Question about TDM1 I don't understand

[CoolBreeze]

I am on halavan now. At my last doctor's appointment, I told him I suspected it wasn't working. (Increased pain, increased tiredness, etc.) None of my chemos have ever worked for more than a month or so. I told him I wanted to get on the TDM1 trial and he agreed. He ordered a PET.

Unfortunately, his secretary is new and I haven't gotten the call yet. It's been 2 weeks. Not complaining but I had it in my head that the trial closes Feb 26th and after that, I can't get in? Is that true? I go in tomorrow and I'll talk to her.

Does the trial close the 26th? How long will it take the FDA to approve it after that? Assuming they approve it quickly, does anybody know how long it will take to make enough drugs so oncology clinics have it, get staff trained etc?

I feel like I should be on the trial by Feb 26th so there is no interruption in treatment. If I have to wait a year for it - well, I'm not convinced I'm going to be around a year.

I know these are hard questions and maybe nobody has the answers but if you can guess, that would be great.

[schoonder]

OK CoolBreeze, let me explain how I see the T-DM1 story.

Based on results from Emilia trial (2nd-line Her2+ mBC) Genentech has applied for and FDA has agreed to priority review of this data. Priority review expedites this process from a ten month event to six months, thus FDA will make a ruling by 26 Feb. Many believe it will be APPROVAL and the decision will be made even prior to this date, however not always is the outcome an approval, for example, FDA could requests further data to clarify sticking points.
With approval as likely outcome, ROCHE has been building up drug's supply to meet immediate demand. Reimbursement by patient of costs associated with treatment of agent by insurance is an other factor for further delay.

How approval will impact the current ongoing expanded access trial, i.e. will new patients be accepted etc. I don't know.
http://www.clinicaltrials.gov/ct2/sh...ansine&rank=16

Other T-DM1 trials will continue as planned and new phaseIIIs in earlier settings will be announced.

[chrisy]

Schoonder is right as usual.

True, you never know for sure what will happen, but I do know from the "last time" this happened, it is unlikely that if you are already in the trial prior to the end date and if you are benefitting from TDM1, that they would kick you off the drug. It would be unethical. If it were me, I'd get on TDM1 as soon as you can if you have access to an EAP. That way you sort of have squatters rights.

By the way I love your blog. It's goals season right now at work and in my business peer group, and I find the entire thing a bit depressing. Maybe I'll see if I can get away with "Get up. Survive. Go back to bed" or something like that. Of course I doubt anyone would pay me to do that, but it would be good for a laugh.

Good luck with your treatment decisions...even and especially if you DON'T need to change at this time.

Chris

[cheery]

Good to see you here Coolbreeze.

This is a little off topic to TDM1 but I was wondering if you've tried Herceptin and Tykerb together to block the HER2+ pathways. I'm not an expert but I've read there's been success with Avastin and 2 HER+ agents (ie Herceptin and Tykerb) + chemo (taxane).

This of course is an interim measure suggestion until you get into that TDM1 trial.

Hope your next treatment will bring some stability to the disease.

[CoolBreeze]

Thank you ladies, for both the information and kind words.

My regular oncologist broke his pelvis before Christmas, poor guy. So, I am seeing another in his group, who agreed TDM1 would be fine for me. I have started having liver pain so I expect this halaven is not working.

I have not been on tykerb. I had a very serious case of c-diff, and almost died. My entire colon was infected, and I had pancolitis. My colon was not in good shape for a long time and tykerb is hard on the colon. I think I'm healed from that now though so can explore that option.

I asked because I agree, they probably won't kick folks out of the trial. I told the doctor that I didn't want to get caught in an in-between place, say the trials are closed but approval hasn't happened and offices/insurance haven't sorted it out yet. It would be hard to be panting for it and have it dangling just out of reach.

On the other hand, there is no trial location in my town and it would mean an hour and a half drive each time. I can manage it now but who knows for how long?

It is time for me to get this NED or Regression or even Stability I keep hearing about. All I ever seem to be granted is progression. But, so far, it has stayed in my liver. Too bad we need livers to survive, huh? Yanking half of mine out was not enough, I need it all gone apparently.

Chrisy, I have another "goals" meme I was going to post. It is a checklist that says, "Bucket List: Ice. Beer."

I'm not a drinker anymore but still thought it amusing. Maybe your group would get a laugh out of that too.

[michka]

Hi CoolBreeze. Happy to see you posting but sad you need a new weapon.
i agree with Chris. No reason for waiting. Go for TDM1 now. Hugs. Michka

[KsGal]

Im so glad to see you post as well. I don't know about the TDM1, but do know two weeks is a long time to wait to hear from them about getting a scan and getting moving.
I love your blog as well. It was probably one of the first things I find after being diagnosed, and your sense of humor and the information there made me feel soooo much better. Laughed through my tears quite a bit!
Sending you so many wishes and prayers and lots of bright energy. You are definitely right, its time to get your NED. These liver lesions are absolutely ridiculous..I get so angry when I see mind just hanging out on my scans like its perfectly comfortable all nestled up there. GET OUT!
Please keep us updated...and big hugs to you. Your positive attitude and sense of humor and energy and intelligence motivates and inspires more people than you know, don't forget that.

[CoolBreeze]

Thank you. It's nice to hear these kind words. I think I've decided I'm just not a "forum" person - I think I come across wrong to people for reasons I don't understand, so have decided to stay away from that medium for the most part.

I don't seem to have any problems here though.

I called my insurance today and it was approved on December 26th. I would call Nuclear Imaging if I had the number to make the appt, but silly me, I don't. I have to wait for them to call me although today is chemo day, maybe I can scroll through old numbers and find it or ask them.

If anybody is so included, I am in a contest - grand prize is $1,000. You can vote for my blog to win, using facebook and/or twitter. I am #2 and would greatly appreciate the votes.

http://www.healthline.com/health/bes...-blogs-contest

Vote daily!

[Sdgirl]

I am in the EAP for TDM1 and received a letter a couple of weeks ago from Genetech that I would receive only one additional dose after FDA approved it and they would work with me and my onc to help me get continued tx and payment from ins. The letter did not have any specific date.

[CoolBreeze]

Oh, that is interesting, Sdgirl.

I think I'm going to get caught at exactly the wrong time for this. We'll see, I should have a PET next week and find out what Halaven has done for me. I suspect, not much. But, maybe I'm wrong.

[Sdgirl]

I think you can still get in. I know someone who got in just last week into the EAP and started tx. Till the FDA approves it, I think the EAP program stays open. I hope your scan shows good results and you do not need TDM1 yet but you can get it if you do. All the best to you.

[Rolepaul]

They already started making the TDM-1 for initial product release. They are getting ready to add additional production through some contract locations until Vacaville and other locations is approved for the production of all material. This is a high priority for the Genentech/Roche team. Information is from non-public sources but very reliable. I will confirm before the end of the month to 100% confidence.

[phil]

I would go for it , EAP. be a squeaky wheel w/ your docs office, and EAP folks. Lorraines " contract " talked about , if appr . occurs , they will supply another dose , til you transfer. Since its every 3 weeks , thats about 6 weeks time ? transfer might be the same facility as the EAP , since they are using t dm-1 already, and your current doc does not. If you start , you want regular doses at 3.6 to get the most effect, every 3 weeks, w/o interruption. meanwhile, if by some crazy reason , appr is delayed, EAP continues to cover you.
And, if cancer has been contained to liver , and you have a type that highly overexpresses her2 ,thats just like Lorraine , and she had a great response, a smaller target . Good luck, God Bless

[KDR]

Coolbreeze,
Stay positive.
Karen

[Joanne S]

Cool Breeze,

Thanks for sharing. I loved your video: http://www.youtube.com/watch?v=3IyHJ...ature=youtu.be

You are a very special lady with tremendous strength and a inspiration to me. I wish you the very best results on your upcoming scan (Halaven treatment).

I attempted to vote for your blog, but evidently I don't know what I'm doing.
I went to :
http://www.healthline.com/health/bes...-blogs-contest
I clicked "vote now" next to Breast Cancer? But Doctor....I hate pink! , but the entire screen just gets highlighted in gray and nothing else happens???? And I have no idea what steps to take to vote on facebook. Please advise.

Thanks, Joanne

[KsGal]

Any new news, CoolBreeze? How were the scans in regards to the Halaven? Keeping you in prayer and thought.

[Mtngrl]

Anne,

Good to see you back with us.

Prayers.