The NCI's response to my inquiry on late adjvuant herceptin trails
 

Just wanted to post the reply from the NCI from the note I wrote them inquiring about late adjuvant Herceptin trails. I am pleased with their response and happy that they seem to be in the planning stage for late adjuvant herceptin trails.

Your e-mail to the National Cancer Institute (NCI) has been forwarded to
this office for reply. In your e-mail, you described your prior
diagnosis with breast cancer and your decision to pursue the late use of
Herceptin(R). In particular, you asked about clinical trials for late
Herceptin and when they would begin. We understand that you have been
through a difficult time, and we congratulate you on being a cancer
survivor. We hope the following information is helpful.

The NCI, a component of the National Institutes of Health, is the
Nation's principal agency for cancer research. The NCI is responsible
for coordinating the National Cancer Program and for maintaining our
momentum in cancer research. Cancer touches all of us, including
scientists and their families, and the work of NCI researchers makes
them keenly aware of the burdens that cancer and its treatment often
impose.

Please be assured that additional follow-up with Herceptin is ongoing to
help determine the long-term safety and effectiveness of this agent.
Although there are currently no data to support the late use of
Herceptin, some doctors are evaluating its ability to decrease the risk
of recurrent breast cancer and are offering Herceptin to selected
patients. Therefore, you may wish to obtain a second opinion from
another oncologist. The NCI fact sheet "How To Find a Doctor or
Treatment Facility If You Have Cancer" provides tips for finding a
doctor, getting a second opinion, and choosing a treatment facility.
This resource is available at
http://www.cancer.gov/cancertopics/f...octor-facility on
the Internet.

Clinical trials for the late adjuvant use of Herceptin have been
discussed, but have not been finalized. As clinical trials become
available, they will be added to PDQ(R), our comprehensive cancer
information database. The PDQ Clinical Trials Advanced Search Page is
available at
http://www.cancer.gov/Search/SearchC...sAdvanced.aspx on the
Internet. This form allows users to search for clinical trials using
criteria such as cancer type, type of trial, geographic region, trial
sponsorship, and/or drug name. You can also select the checkbox for New
Trials (those added in the last 30 days). Information will also be
posted to the NCI's Herceptin Web page, which includes links to press
releases and clinical trial information. This resource can be found at
http://www.cancer.gov/clinicaltrials...page/herceptin on the
Internet.

If you have additional cancer-related questions, we encourage you to
call the NCI's Cancer Information Service (CIS) for personal,
confidential help. The CIS is the source for the latest, most accurate
cancer information for patients, their families, the general public, and
health professionals. To talk with an information specialist, please
call 1-800-4-CANCER (1-800-422-6237). For callers with TTY equipment,
the number is 1-800-332-8615. NCI information specialists also offer
online assistance through the Help link at http://www.cancer.gov/ on the
Internet.

Thank you for writing.


Deborah Pearson, R.N., M.P.H.
Chief, Public Inquiries Office
Cancer Information Service
National Cancer Institute

Late herceptin trials
 

Robin, this certainly fits in with the rumblings I've heard elsewhere and is encouraging. I sure hope that by the time they actually get a "round tuit" and put a trial out there, those in this situation won't get "bumped out" yet again by being "too far out" from treatment to fit into the trial parameters... Thanks for pursuing this so persistently. How is the Herceptin treatment going?

A.A.

Hi..

Well these posts seems to fit right into everything that I have been looking into.
Alaska....I seem to be in the same boat as you in getting late herceptin. I was looking into clinical trials to see if any offered late herceptin. In my mind I was thinking I would rather have it sooner rather than later. But you bring up a good point about other clinical trials not open if you have already received herceptin. This is boggling my mind. My onco said if I had more postive nodes than one, then she may start me on it. However with one positive node, she didn't think it likely or wise. I think I could persue it with her but I just don't know what is the right thing to do at this point. At the time of my dx 4/03 (inished treatment 12/03) I was not even informed of the potential dangers for being HER2+++ so at the time I didn't even inquire about the clinical trials offered. (I am still mad as heck about that, but trying to move on !)
If anything else comes up about clinical trial, I would love for you to share it with me.
Thanks
Kristen

Darned if we do and darned if we don't
 

In terms of a clinical trial, it was mentioned on a Cancercare conference just after the San Antonio meeting that there likely will be clinical trials offered for us "sometime" in 2006, and I have heard it mentioned elsewhere as well. I think Robin has the right idea and writing the NIH is a good place to start and that is what I did too, and I would encourage you to also. The way things are, any of those who recur "late" will get Herceptin of course, but since Herceptin is now being given right off the bat to all the HER2's who are within 6 months from treatment, that doesn't make much sense to me. Why would their hearts be able to stand up to it better than ours would?

A.A.

Hi AA, thanks for asking how Herceptin is going. It went okay during the infusion. I have some back pain which started a few days after the infusion I wonder if that is somthing like necrosis that is going on. LOL, if it keeps up I will definately have a scan done on my back.

I hope late herceptin trails actually get off the ground. I am concerned for the population of her2 breast cancer patients who have minimal knowledge available to them for the benefit of Herceptin and I ethically think that is unfair to leave them out clinical trails.