Neratinib Clinical Trial

[v-ness]

please excuse my ignorance. i assume one must be completely done treatment to take part in this trial, yes? just thinking ahead. i will complete herceptin in october and there is a trial site near me. i would happily apply to take part if they are still accepting people at that time. valerie

[carykim]

You have to be within 2 years of your last Herceptin and currently NED to enroll.

Vanessa--I read on another board that a few women finishing up Herceptin "prequalified" for the study so they could just roll right in after their last infusion. Worth inquiring if you aren't burned out on treatment come October.

I'll cut and paste some info I saw on another thread:

Must have received Herceptin within 2 years and be NED.
The main purposes of this study are:
1. To find out if Neratinib helps to prevent cancer from returning, or if it may help to delay the time until the cancer returns.
2. To find out how Neratinib affects overall survival.
3. To learn about how Neratinib affects the occurrence of brain metastases.
4. To learn about the safety of Neratinib.
Approximately 3850 subjects is expected to take part in this study. It is expected that you will be in this study for 5 years (one month for screening, one year receiving the drug and 4 years follow-up) Follow up tests every 3 months include ECHO or MUGA of the heart.
Herceptin and Neratinib are alike only in the aspect of each being able to target HER-2 (erbB-2). And may pose the same side effects such as ventricular dysfunction and congestive heart failure.

Based on safety information from the subjects who have received Neratinib in research studies to date, the following side effects have been identified:
1. Diarrhea - most can be controlled by anti-meds.
2. Dehydration
3. Anorexia - lack of appetite - weight loss

4. Nausea/Vomiting
5. Rash
6. Abdominal pain
7. Elevated liver function tests that may indicate liver damage.

HTH,
cary