Need help from TDM 1 girls

[michka]

Dear all
I am getting ready in case Herceptin and Navelbine doesnt' work. I don't want to go through other toxic chemos before trying TDM1. I am suffering too much from neuropathic problems;
But in my case it is complicated. Herceptin and chemo never worked for me. I was ER+90% PR+20% at diagnosis 4,5 years ago then in December after laparoscopy ER+20% and PR0 then in March after resection 70%ER+ and 0%PR-???? Here are my questions:
1) How often is TDM1 given? and for how long? For ever?
2) I am american but live in France. Does anyone know of a European trial?
3) I do not want a TDM1 trial against Taxol and Herceptin. I had that in neoadjuvant setting and it did not work a all
If necessary I can live in the States for some time although I will be broke. But who cares.
Any European friends with some ideas?
Is there anyplace I can call at Genetech to discuss this?
I am sorry for these questions because it is clear in my head but the English is not as precise as I would like it to.
Thank you for your help.
Michka

[Debbie L.]

Michka, surely there are trials in Europe. Your oncologist should know how to access a database for them. I gave it a try but have no idea what is the best resource.

A quick googling for a trial database in Europe brings up so many hits it's hard to know what's legit but this one seemed current, and was written up just in March in some journal: https://www.clinicaltrialsregister.eu/

I searched it for tdm1 breast cancer and got two hits -- there is apparently a phase IB/II trial in France, for example, with pertuzumab (no taxane listed). In those hits, they listed tdm1 as "trastuzumab-mcc-dm1", so I searched with that and got more, with lapatinib, with chemo of choice, etc:

wyciwyg://24/https://www.clinicaltri...eu/ctr-search/

Can you let us know what you find out? Because we want to know how you're doing, and because it might be important information for someone else in Europe, looking for trials.

Debbie Laxague

[schoonder]

Michka, here's a link to all T-DM1 trials, contact information and their current status.
http://www.clinicaltrials.gov/ct2/results?term=t-dm1

Although "weekly" dosing has been looked at, Genentech currently doses on a three week schedule. As long as drug remains efficacious, even after completing trial, Genentech will continue to provide for drug.
Don't rule out any of the trials because passed experience with trastuzumab because T-DM1 has functioned in patients that were non-sensitive to Herceptin.
Contacting Genentech directly might give you best idea as to how to proceed.

[Debbie L.]

Very cool, Schooner. I assumed that clinicaltrials.gov would only have US trials. Do you think it includes trials that are exclusively outside the US, or only those that are both in this country AND in other locations?

Michka, try clicking on the "results on map" tab near the top -- then it's easy to see how many trials are in each country, and by clicking on the country, you'll get a country-specific list.

Debbie

[schoonder]

Debbie, I've seen entries for USA only, overseas only or both; link is an example with agent sar3419, 1st entry is stateside, 2nd entry is in France only, etc.
http://www.clinicaltrials.gov/ct2/results?term=sar3419

[Joan M]

Micha,

I don't know directly about European, T-DM1 trials, but you may want to contact Giuseppi Viale, M.D., European Institute of Oncology, University of Milan, Italy. He's involved in breast cancer HER2 research and speaks English. I'll PM his contact information.

I hope you're recovering well from your surgery and feeling better, and it's great that you're looking ahead.

Joan

[hutchibk]

Here's the link to the US 'compassionate use' arm of TDM1. I would move swiftly, though. You never know when this might close to accrual. http://www.clinicaltrials.gov/ct2/sh...%2F2010&rank=1

Have you tried Tykerb yet? Either with Xeloda or w/ Herceptin?