study being done on herceptin with no chemo/for elderly patients

Jean · 08-26-2010, 05:55 PM

Found the following trials being done....without chemo just herceptin on elderly patients.

http://clinicaltrials.gov/show/NCT00796978

http://www.cancer.gov/search/ViewCli...archid=8049743

AlaskaAngel · 08-26-2010, 09:05 PM

Makes sense to me, Jean. Thanks for helping anyone who might benefit from it to know trials are being run for trastuzumab without chemo that they might qualify for.

AlaskaAngel

AlaskaAngel · 09-01-2010, 01:42 PM

Thank goodness for the women who are willing for various reasons to avoid chemotherapy altogether, so that there might be more knowledge (and not just blind hope) available for a greater number of people in the future.

A.A.

imdavidson · 09-01-2010, 06:51 PM

Jean, this is very, very interesting, thank you for posting.

Alaska Angel, we had talked before about looking to see if there were any Herception-only trials for early-stage breast cancer. I spoke to the publicist at Genentech and she said that to her knowledge there has never been one.

As you know, there have been trials (and it's prescribed) as a single agent for treatment in patients with metastatic disease who have received one or more chemo regimens.

It's also prescribed for any HER2-positive breast cancer with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or with docetaxel and carboplatin (which is what I had); or as a single agent following anthracycline therapy.

When I asked her why Genentech hasn't studied the drug (as a single agent without chemo) in early-stage patients, she couldn't answer but said she would have one of their scientists call me to discuss further. I'll report back.

Lani · 09-02-2010, 01:52 AM

It has been explained to me thusly:

A clinical trial must offer a new drug or alternative drug regimen/combination PLUS the gold-standard treatment in any trial for moral reasons (and medicolegal ones)

Otherwise they would be denying the person in the experimental arm the best treatment known to help them.

If you read the trial information it requires that the person be unwilling or unable to take the chemotherapy--thus getting around that problem.

Hopeful · 09-02-2010, 06:51 AM

I believe it is possible to test the agent without chemotherapy when used as neoadjuvant, rather than adjuvant, therapy. This is most likely the other area where trials can be done. I also seem to remember reading there may be interest in trying to use Herceptin alone in DCIS patients.

Hopeful

Jean · 09-02-2010, 08:33 AM

Hopefull,
You are correct about herceptin trial with DCIS.
I remember posting something on this a while back.
I will check and try to find the research and post it.

imdavidson, thank you for calling Genentech and being so pro active for all of us!!! I have always found when we reach out to dr.'s and companies they are always so thoughtful and helpful in answering our questions.

When we reflect back the last 10 years great strides have been achieved. The last 10 years I believe we have been exposed to some of the most profound research.

Jean

Jean · 09-02-2010, 08:49 AM

Found this research trial being done. I know there are other trials - will continue to research.

http://www.deepdyve.com/lp/clinical-...ast-PKQnSs8ahI

AlaskaAngel · 09-02-2010, 11:02 AM

We each have had different experiences, and some of us have been around a little longer than others and have a somewhat different impression. For those who walked in to the oncologist's office and were offered trastuzumab with chemo at time of diagosis, it can seem like medical providers are miracle workers.

But for those HER2's who were a year out from completion of chemotherapy without any trastuzumab, listening to the ASCO announcement of the success of the trastuzumab trials was far less than impressive. The silence of the oncologists in our behalf was deafening. A week went by, and then a month... and then more months... and they made no recommendation at all for us. The only thing we had to hear over and over was the radio and TV news telling us how "all HER2 patients were being treated with trastuzumab". We were given no answers by any medical providers about what those patients who had completed chemo without it should do.

As anyone who was here then will remember, that meant that the vast majority of HER2 positives that were known at that time were left high and dry with no explanation from anyone. Eventually a very few scattered oncs here and there tried to say something supportive to us, but had no answer to give us. I can't respect that failure by medical providers to be honest with us and then to get down to it and DO THE HOMEWORK in our behalf.

So here we are, almost a decade later, still not having clear answers as to whether trastuzumab alone has value or not, because of a decades old practice of being forced to continue to use the "gold standard" drugs that are not targeted drugs but applied randomly.

I support these women (and the researchers involved in it) for stepping out in front and having what it takes to do treatment without chemo with no more garantee than any one of us gets by doing chemo combo treatments.

AlaskaAngel

Rich66 · 09-02-2010, 08:10 PM

"the vast majority of HER2 positives that were known at that time were left high and dry with no explanation from anyone."

Oh boy..that one still stings. But mom's rad onc said she was cured so I let it go....

For what it's worth, post recurrence, mom got a few months of stability on H alone. See history below.

09-02-2010, 09:25 PM

Some of you may remember that I was one of those who didn't accept the offer by onc to take both chemo and herceptin. My onc would not do the monotherapy with Herceptin. I relied on A.I. as my defense against recurrence. So far I have been very lucky and my five year anniversary is this week. Too bad that they have an age criterion for recruiting patients for the monotherapy trial. Also, the results wouldn't be known until 2015! Still, I am definitively interested in this subject

Ann

CLTann · 09-02-2010, 09:31 PM

My registered name is CLTann. I will repeat my message below:

Some of you may remember that I was one of those who didn't accept the offer by onc to take both chemo and herceptin. My onc would not do the monotherapy with Herceptin. I relied on A.I. as my defense against recurrence. So far I have been very lucky and my five year anniversary is this week. Too bad that they have an age criterion for recruiting patients for the monotherapy trial. Also, the results wouldn't be known until 2015! Still, I am definitively interested in this subject

Ann

Jackie07 · 09-02-2010, 09:39 PM

Happy anniversary!

I'd suppose that you were highly ER positive. I'm weakly ER and took Tamoxifen by my own request. Now my oncologist wanted me to continue Tamoxifen, go figure!

AlaskaAngel · 09-02-2010, 10:23 PM

Rich, I am so sorry you and your mother have had to go through all of it, and feel your way through the confusion as best anyone can. I only hope better answers lie ahead to help you both, and that your careful research leads you to them.

AlaskaAngel