Neratinib Trial

[TSund]

Ruth has been asked if she would like to participate in the Neratinib trial. (pre-metastatic) She is really, really torn about it. She is so ready to be DONE. She is on schedule to move to visits with the onc every 6 months unless she does this trial.

As I understand it, this drug does have a plus that Herceptin does/did not, in that it is thought to cross the blood/brain barrier. It also is given orally. It does have a high incidence of diarreha, something she is not thrilled about. She is however thinking that participating in a trial is a way to "give back", and possibly give herself another dose of met prevention. I don't know if the severity of diarreha is similar to that which she experienced with TCH.

If this drug has the potential to make as much difference as Herceptin (something I have no idea of) it seems like it could be a huge counter-punch, and possbily more useful than the AI she will move to from Tamoxifen in 6 months time. Of course, she could be among the 50% that receives the placebo, however if she partcipates and does get the diarreha, it's a pretty sure bet that she's receiving the Neratinib.

Any wisdom would be appreciated.

Thanks

Terri

[Patty F]

Terri
I too have contacted the Dr. in our area to participate in this trial. I go this next week for a pet scan, muga and EKG. I then see the Dr. again on Friday to see if I qualify. I will keep you posted.
Like you said I just want to do something to give back.

[chrisy]

Tough decision for sure. After nearly 2 1/2 years, no wonder Ruth is ready to be done and move on to the rest of her life! To be honest, I have no idea how I would answer the question she is facing.

What I do know, from the report at SABCS on the early trials of Neratinib, is that it does work differently than either Herceptin OR Tykerb, and is presumed to cross the BBB so that may be protective in case any of the little buggers escaped herceptin.

The diarreah side effect seems to be nearly universal on this drug; however the data reported out at San Antonio indicated there had been NO discontinuation of treatment due to this. The implication of this being that people learned to "manage" it, much as most people do on Tykerb. Of course, the population in this study was all metastatic patients so there was probably a bias towards learning to tolerate the treatment if it might be working!

Terri, you and Ruth have been through a lot with this and I understand why the doubts. Do what feels right for you (Ruth).

Take care
Chris

[TSund]

Chrisy,

I'm so glad to hear from you and I'm glad that you are doing well. Thank-you so much for taking the time to answer the post.

Did you talk to anyone that had been on Neratinib? Do you or anyone else who'd like to chime in have any perception of the effectiveness of this drug vs Herceptin vs T-DM1 vs Tykerb, etc?

Terri

[DanaRT]

I am interested in this. My onco is misinformed. She thought you still had to be in treatment. I am going to ask about it when I see her again. As Ruth feels, it is a way to give something back in the way of research.

Keep us posted.

[Mary Anne in TX]

I'm so excited! I just got a call from the research dept. at the clinic where I go. My doctor recommended me to be on the Neratinib Trial. I'll go for all the testing at the end of this month. I hope I pass all the tests and can participate! Far too many needing new drugs...maybe this is one that will help! ma

[micheleu]

I'm confused. What stage was she? stage 3? Are they doing the trial to prevent recurrances? I took tykerb for 3 months and the diarrhea is bad. But i think ones body would hopefully get used to it!

[TSund]

Hi Michele,

Yes, this is a pre-metastatic trial. I would suppose Ruth's stage was 3 a/b/c but it is a little hard to call. Her situation seems somewhat unusual in that her tumors were absolutely huge (multi-focal, 9cm+) but there is not absolute certainty that her nodes were involved. (the onc thinks probably yes) She had pre-surgery chemo, and the TCH+ shrank the tumors to basically nothing, and the sentinel node biopsy was negative, so she did not end up having all nodes out as would normally be the case in a cancer of this size.

Strange and mysterious but I'm sure not fighting it.

So, while she had an incredible positive result with the initial treatment, who knows if more treatment is necessary or not, and whether this trial could provide more insurance.

I'm of the mind lately that we or someone should go on the trial and send them to Sheila. Drives me nuts that Ruth can get this drug and all of these scans for free and Sheila cannot get the treatment she urgently needs.

[Mary Anne in TX]

Hey, Terri, that is the same trial that I am trying to enter. I know we might spend 5 years taking a sugar pill (not sure we'd go past the first year), but all the testing is included for participating. It seems to be from reading the material which came with the consent form that it is an attempt to have a program similiar to that that E+ people can do with 5 years of followup drugs.
It would be terrific if it worked for us E-, P- folks.
anyway, I do hope to get in the trial. But I so understand Ruth wanting to be done.
I'm older and am so focused on getting 10 more years to rear this outrageous granddaughter of mine!
Sometimes old is good! ma

[schoolteacher]

Terry and Mary Anne,

Please let us know what is happening with the trial.

Terry, tell Ruth I said hi. I am still walking, and now I do Yoga twice a week.

Amelia

[TSund]

Hmm... the trial that they are talking about with Ruth is a 1 year trial. Tho I suppose they certainly keep track for several years afterwards. I don't think the ER status is relevent but I am sure it is a factor that they track. (Ruth is ER+)

I'll try to take a look at the documents that they gave us.

Mary Anne, you've been through lots of "extra"treatments on top of the original chemo without complaint it seems. I'm assuming you have been doing the other treatments because of the heavy node involvement? I'm curious...where are you getting treatment?

TRS

[DanaRT]

Terry, Anxious to hear if Ruth is going ahead with this trial.

Love,
Dana

[Mary Anne in TX]

Hi Terri! I go to STOH (South TX Oncology & Hemotology) in San Antonio. My Dr. helped to start the clinic and has been wonderful! And you've probably noticed that I feel that I've had incredible care and treatment! I have been treated so kindly and with such respect. But most importantly, I received the treatment that I so wanted. During the first year of treatment, I checked out the treatment protocals of other places (Anderson in Houston for 1 since it is 3 1/2 hours away also) and ones in New York and California. I found that for my diagnosis, age, and past medical history, I was getting the treatment I might have gotten in other places, if treated agressively as I wished for. I feel very, very fortunate. This trial would just be the frosting on the cake for me! I know there are no promises and I expect none, but I do want to do my part. And I'd love to be able to help find out if another drug could hold this stupid disease away for more years for us all. Best wishes on Ruth's decision. ma

[Patty F]

Mary Anne...I am starting this trial next Friday. I go to the Dr. for the medication on the 30th. I am excited to have been accepted.

[Mary Anne in TX]

Patty, let us know what's happening! I'm so excited, a bit nervous, but mostly just grateful to have a shot at it! I see the doctor and do the muga, chest Xray, bloodwork on the 30th and then the mammogram on the 2nd. They said they'll decide on the scans dependent on the bloodwork, etc.
Tell us how many pills...well everything!
ma

[lisajones4]

I am very interested in this to since I was stage IIIa. I have been searching for info on the web, but everything I have read talks about having metastic breast cancer to enroll. I have just left a message with my oncologist to see if there is anything at Northwestern. Please let us know if you find anything more about it. Thanks

Lisa

[lisajones4]

I found some great information on this community board on the trial: http://community.breastcancer.org/fo.../740167?page=1

[TSund]

Lisa,

I'm sure someone in Chicago is doing it.

Dana, I have a feeling Ruth won't even decide or get going on this until after Christmas. Personally I might be happier if she would pursue more immediately, but this has to be her choice. We are going to the Philippines for Christmas and I think she just does not want to deal with the possibility of side affects during that trip. We are also leaving the country during Thanksgiving, so it makes everything a little more complicated.

MaryAnne, I am SO glad that you are happy with your oncologist. It's so important. Ruth is going to Baylor Hospital in Dallas and works with Dr. Joyce O'Shaughnessy, who is quite a wonderful doctor and researcher. (which would be why she has such immediate knowledge/access into these trials. We had to fight hard to get with her initially, but once Ruth was a patient it was great. She is a remarkable woman.

Googling her is an interesting thing as she is also often quoted in media articles on breast cancer. It seems she is one of the "go to" people for an accessible and knowledgable interview.

I think this trial is involving a large number of patients, and you have two years from the end of initial treatment (end of Herceptin in Ruth's case) so enroll. Should be pretty accessible for many folk I hope.

Best to all!

Terri

[Laurel]

It says Neratinib is:

An orally available, 6,7-disubstituted-4-anilinoquinoline-3-carbonitrile irreversible inhibitor of the HER-2 receptor tyrosine kinase with potential antineoplastic activity. Neratinib binds to the HER-2 receptor irreversibly,

I wonder what implication the irreversible part may have on the her2 receptors in heart muscle? Tykerb is reversible and it does not say regarding Herceptin. My comprehension is so very limited. Perhaps I am over-thinking this? Lani? Anyone?

[Mary Anne in TX]

Hey Laurel....I wondered about the very same details! I'll ask about all that when I talk to them. ma