Neratinib Clinical Trials

How did everyone fare with hotflashes/night sweats?

All of a sudden I am waking up at night just drenched! I am on tamoxifen, but thought I was through most all the flashing!! Did anyone have it flare up again?

I saw my trial onc and nurse today. I sure didn't come away with the warm fuzzies on the direction of this trial.

It seems that their opinion is that the Pfizer is losing Lipitor this week to generic status and next year will lose Viagra, most of their bottom line profits.

So, they elected to clear the slates and get rid of a few trial drugs. By selling it off, they retain some royalties on any future sales. It is hugely expensive to get a drug through the fda process and to market and the larger companies have more stringent reporting requirements. It is thought that smaller companies, IF they can fund it, fare better.

We will not see any followup data for 3-4 years. The trial is being redesigned since this one is not "useful" because the amount of the drug tested, at 6 pills and 240 mg, was widely not acceptable and unsuccessful. For a drug to be considered successful, the trial has to be designed at the correct tolerated dosage. So for the results of this trial to be used to forward this drug to market, it would have had to have been designed at 3 or 4 pills. My onc said that the word on the street was 3 was the most commonly tolerated dosage. So more than likely we will see more folks enrolling in 2012 in a new trial at 120 mg, or 3 pills. Followup care on this current trial has also been reduced from 5 years to 2.

I am almost halfway through my trial. I have poured over the trials of this drug from around the world. I am no longer so sure that I want to stick with this. I am not so sure that I am not doing more harm than good. My bloodwork is just OK, the numbers are lower than what I usually am registering. Maybe I will get to the first of the year and make a decision then.

I'd love to hear any thoughts on this!!

Does anyone know if white blood cell counts drop the longer you are on the trial? I don't know whether I am on the drug or not--but in the last couple of months, my white blood counts have slowly but steadily dropped. Wondering if that is any indication that I'm on the drug? And, should I examine other levels in my latest blood test that might help me figure out if I'm on the drug? Thanks

Good to hear you came through it well CBM. Gemini, my wbc is lower than when I first came out of chemo, and now I am having lots of hotflashes out of the blue. Nothing else has changed in my diet or routine.

Hi, KCFS, the press release is posted by RKR on October 8, page 31, of this thread.  From the PR Newswire; which I assume is Puma itself.

I wouldn't conclude that Neratinib doesn't work as a preventor, only that it may not be cost-effective as a choice, or that it doesn't adequately outperform Herceptin.  The prevention of brain mets--its superior effect--would have to be balanced by the large number of subjects who got bad side effects.  If only a few would have progressed in exactly the way that the drug defeats, it might be too tough a sell to all of the insurers, oncologists, and women who already had a year or more of Herceptin.  

In my own case, I am glad that I got the year and that I got the screening tests coming into the trial, which for me included a few I would not have gotten.  Feeling sure I got the drug, and knowing it works on mets, I'm comforted that I had three years of recurrence prevention (two of Herceptin and one of Neratinib) instead of only one.  I only have two more years in the recurrence window for Her2 (and then like eight or ten or something on the ER/PR+ component.  I loathe Femara, and my doctor says I don't get to stop after 5 of that). 

I don't know about margins; I had mastectomies, but I do know about reading and re-reading the path report.  I think sometimes that I expect it to reveal Truth and Light, but it's always the same, and I don't understand it any better. 

Warmly,

Cathy 

KakaCath - I am a cytologist and I work in a pathology lab in a hospital.  I can explain that report if you'd like.  I can also ask one of our pathologists.  As I understand it, Neratinib and all the tinibs are not cytotoxic in the way many chemotherapies are.  Chemo drugs kill fast dividing cells as well as normal cells.  The normal cells can rebound better.  Neratinib blocks the actions of enzymes that effect the proliferation of cancer cells.

Hello Friends.  I am almost two months from having completed the trial.My only side effects were neuropathy in both feet that came on very suddenly at about day 7 or 8, and severe diarrhea when taking Keflex.  I just wanted to report that I am taking a full course of Keflex and have not even a hint of the D, and that my neuropathy is starting to resolve.  I'm in the burning, itching, tingling phase of nerve regeneration and my physical therapist confirms this is most likely a return to normal or near normal.  

Let me add, I had not realized how tired I had become toward the end of the trial.  I feel much much better.

My oncology team was not sure if the neuropathy was reversible, but in my case it is improving every day now.

Warmly,

Cathy 

Hi there!

There was some info released, not on our trial but on a few others that were slightly promising. Neratinib was used in tandem with another drug...so its hard to compare. In the arm that got only neratinib there was some slight benefit. I still wonder if I am doing more harm than good with this. I am half way through it. Go check out the clinical trials thread....I believe I saw it there. Hope you have been doing well and are enjoying the holiday season!!

Saw my oncologist and research coordinator today.  She told me about the trial ending and that I would only be followed for 8 more months.  My onc said, "you were on the drug arm, right?" I told him I didn't know.  He said I will eventually be getting a letter telling me if I was on the placebo or the drug!  He said they are required to tell us.  He didn't have a lot of info about what Puma would do with the drug but, was dissapointed that he trial ended.  He said without a long term study they won't really be able to say the drug prevents recurrance or just delays it.  Anyone still in the trial know if you will discontinue taking the pills?

Thanks kward. I am curious. I wonder if its because pertuzamab has had such great results? I know they cant push forward with this trial as designed because they started with too high of a dosage...they have to do a trial with 3 or 4 pills to get it furthered along. I have been a bit slack taking those pills honestly...especially right around the holidays!

Hello ladies. First off kudos to you all for taking part in the trial. Hopefully what we are doing will help others in the future. I started the trial in October. saw the research nurse 12/9/11 to sign new consent form since follow-up changed from 5 to 2 years. Nothing was said about trial ending so I continue to take my 6 pills. Anyone heard anything new on this?

Geewhiz, thank you about posting re hot flashes. Never had them before but 3 days into the trial, I'm suddenly boiling in my skin!

Hope everyone has a good Xmas.

Oh my god, I am so the same, everything seems to be infected, and non stop, with a flow on effect to the next infection, where-ever that might land !!! San Antonio write up about us, the mono-therapy single arm study results say the side effects out-weigh the benefits, but over-all has a very promising outlook, Im reading this drug needs to be refined or reduced to a safe level for the WCC to turn-over normally, and achieve the Pathological Complete Response Rate at the same time.

Any body see Barbara Haley MD & Joyce O'Shaughnessy MD speak about the 40% chance of having Brain Mets ! I hung on every word they said, and repeated it over and over again ! and just about shit my paints afterwards with that thought !!! Well I guess thats why where all here doing the same thing, desperately trying not to reach stage IV and or with brain mets.

But with a low WCC for a long period may lead to other undesirables, then again others do not seem to experience the same outcome, so that brings us back to square one again, Hoe-Hum.

*** HAPPY NEW YEAR *** to you too gh, and all, Thanks for posting..................

I'm not a statistician but I believe this is correct.  We have varying degrees of relapse (based on node involvement etc)  For me I believe my risk of recurrence is somewhere around 25-30%.  Maybe you mean, out of that 30%, about 40% risk brain mets???

 But again, I'm not a statistician....

Hello Ladies,  I finished the drug in May and saw my research oncologist a couple weeks ago.  She said that even though the trial is being wound down that I will continue to be followed for the the five year period. 

My understanding of the issue of brain mets and HER+ is that more often if cancer metastizes it more often goes to the brain.  The thinking seems to be that Herceptin doesn't cross the brain-blood barrier, but Neratinib may cross.  My hope in entering the trial was to perhaps reduce my risk there.

Boo 

Hormone update.  My OB did FSH and estradiole levels on me and says I am post menopausal.  I had a normal cycle in Dec.  He wants to do an edometrial biopsy.  I declined.  Anyone else in their mid 40's or younger experience this?