Herc/DM1 trials

[John21]

Anyone have any new information on the Herc/DM1 trial. I found the idea promising and was wondering if anyone is doing this with success?

[runtolive]

there is much promising data about to be released today in abstract form for the ASCO conference later this month..

data is supposed to be in regards to the weekly dose escalation currently in phase 1 , but about to go to a pivotal phase 3 trial later this year. caryn and barb, are in the weekly dosed study on this forum.

[StephN]

Hi John21 -

My med onc was talking about that trial yesterday. No numbers, but she said it will be opening in my cancer center soon. And that with the great results she has heard about from other clinicians she is excited that it will help many. She is very tuned in and participates in a lot of breast cancer meetings.

And just look at the good results that Eric just posted for Caryn, who is on this trial!

[Unregistered]

I have had my fourth treatment of T-DM1, I get them every 21 days. So far it has been more than tolerable. I had 5 lesions in my liver and 2 in my back lymph nodes . All have gone! Praise God. I'm praying this will be the miracle drug. I pray this trial gets to phase III and many more women will be able to participate.
Verna

[hutchibk]

Is the Herc/DM1 trial the same as the T/DM1 trial and also the same trial that Chrisy is having great results with? Are they all one in the same?

[Barbara H.]

I think you are all talking about the same trial. Other than Herceptin alone, I cannot imagine an easier drug to take. It has been and still is a miracle drug for me. My oncologist said they are in the early stages of discussing a stage 3 trial, but he didn't mention any dates. I would certainly recommend this trial to anyone to can get into it,
Best wishes,
Barbara H.

[chrisy]

Bhutchybrenda,
yes, this is all the same trial.

Sounds like it's really kicking cancer butt for Verna!

John, I haven't heard any new info on the trial, only that it is continuing to accrue (quickly, as word is getting out!) and they are still opening new trial sites. I think they are expecting to report out more data from the phase I trial at ASCO.

Beyond that, they've made some changes to the 3-week trial protocol which gives a little break in the weekly exam requirements after cycle 7. Which doesn't do anything for the availability, toxicity, or efficacy of the drug but does allow for people to have a little holiday in between tx.

[Verna]

It is all the same study. What's been explained to me is that it's Herceptin with some sort of cancer agent added to the chain. When the Herceptin gets between the receptors, the cancer agent drops it's bomb in the tumor, and kills it.

I've been told there are only 82 of us in this phase II study, and they are looking for more women to participate so they can move onto phase III. So if any of you fit the criteria, HER2 +, Tykerb/Xeloda not responding.

It sure has been my wonder drug. I pray everyday this is the one that keeps the dark monster out of my body.

I pray for us all.

-Verna

[hopefulbear]

Verna-- Are they really going into Phase III? They just put two new Phase II trials for T-DM1 up today! This time, no requirement to have previously relapsed on Herc :)

[chrisy]

The phase II q3 week trial is supposed to include "at least" 100 people...so it is not even fully accrued yet so I would think that although they would be planning for a Phase III trial, this would not move forward until at least some data had been reported out of the current Phase II study.

Hopefulbear - where did you see the information about new phase II trials? That actually sounds like the beginning of a head to head comparison of regular vs. DM1 Herceptin which I would think of as more of a phase III type thing. It also surprises me, with Herceptin based treatments being standard of care and T-DM1 efficacy not being "proven" yet.

That said, if this is all true, that's actually pretty exciting as it shows science running faster and opens up more chances for people to try these new therapies!

[hopefulbear]

Chrisy-- The new trials are up on clinicaltrials.gov!! I'm really curious if they'll expand the Phase II because they don't have any sites in CA, which is a very real barrier of entry.. I wonder why they don't recruit in the most populous state in the US, and also the location of Genentech??

[Barbara H.]

They are only beginning to discuss a stage 3 trial.
Barbara H.

[Ceesun]

Please clarify-is that trial open for those whose response to xeloda/tykerb is not good? Is this the one some call"super Herceptin?" Ceesun

[chrisy]

Ceesun,

The Phase II trial I am in is open for Her2 positive who have progressed after a Herceptin based treatment. If you are currently on Tykerb/Xeloda it's probably because you've already had Herceptin and then had progression, so you would fit under that criteria. It's not necessary that the "most recent" poor response is Herceptin; I was on Tykerb/Avastin just before going into this trial.

Yes this is the "super Herceptin" I'm hoping they will upgrade it to "super duper Herceptin".

The main other restriction is that you have had 1 but no more than 3 chemo regimens. By the way, herceptin and Tykerb do not count as chemos, and if you get a combo like T/C, I think that only counts as one.

[sarah]

Hello,
where can I find info about getting on this trial - it's for a friend?
thanks
hugs and love
sarah

[chrisy]

Sarah, here is a link to the trials. The one that is currently recruiting is the one I'm in - every 3 weeks. Note, the description of where the study is available is not accurate, there are other locations but I don't know where (besides UCSF where I go!). Also note, although the treatment is every 3 weeks there are weekly labs and follow up.

http://www.clinicaltrials.gov/ct2/results?term=Trastuzumab-MCC-DM1&recr=Open&cond=Breast+Cancer

[Jackie07]

Such wonderful news! We need stars on this thread. :)

[sarah]

thanks for the info
sarah