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Old 12-21-2009, 11:30 AM   #21
StephN
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Re: Neratinib Clinical Trial

Hi Kriss -
Nice to see you, but not your symptoms. At least you must be getting the anti-cancer effect along with the side effects. Let us know how the rest and restart goes.

Perhaps your diet must be adjusted as well. The gals on Tykerb found that to be usually the case.
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MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 12-21-2009, 12:58 PM   #22
chrisy
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Re: Neratinib Clinical Trial

Kriss,
Hang in there, hopefully they will be able to find the right dose for you.

I remember last year at San Antonio when they reported the results out on the initial Neratinib trials, diarrhea was universal (In the study participants, not among the people hearing the report) Afterwards Dr. Love commented in the Alamo Mentor session that it sounded like prep for a colonoscopy!

But interestingly enough NOBODY had discontinued the trial due to this. The population in that study was Stage IV patients so that may have made a difference, but it did seem that most people eventually were able to manage the side effect.

Good luck, thank you for participating in the trial
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June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure

Last edited by chrisy; 12-21-2009 at 01:00 PM..
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Old 12-23-2009, 11:23 AM   #23
KRISS
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Re: Neratinib Clinical Trial

Thanks ladies for the support. After going to the bathroom 37 times in a 24 hour period and vommiting they took me off the drug for 10 days. After one missed dose I feel like a new person, almost back to normal. This will at least get me through the holidays. I plan to try it again. They are not sure yet if I will challenge the dose a gain or since my reaction was so violent start me at a lower dose. Steph, what kind of changes did they make to their diet? I'm trying to do low to no fat. I don't eat red meat, and have been trying to cut out dairy. Is there anything in particular?
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DX IDC AT 42 12/7/06
2.2CM STAGE I GRADE 2
NODE NEG
PARTIAL 12/18/06
HER2+ /ER+(75%) PR+(5%)
4 DD AC CHEMO STARTING 1/10/07
4 DD Taxol Starting 3/5/07
1year weekly Herceptin starting 3/5/07
finished 2/18/08
changed to every 3 weeks 4/23/07
completed 33 radiation treatments 7/6/07
TAH and BSO 9/24/07
start Femarra 10/8/07
Started Neritinib trial 12/14/09
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Old 12-23-2009, 03:18 PM   #24
Sandra in GA
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Re: Neratinib Clinical Trial

Kriss,
When I was on Tykerb, I had problems, but they were not as severe as yours. I learned to take two imodium along with one Lomotil as the very first sign of a cramp. I had no diary and went on a low fiber diet. I could not eat fresh fruits and veggies. If you Google "low fiber" diet you will find some helpful information. The only green vegetables I could eat without problems were green beans and asparagus. I also switched to white bread as whole grain did a number on me also. Basicially, I just stopped those healthey habits I had developed as far as eating fiber was concerned. My dosage had to be lowered, but I feel that I was very lucky to have the opportunity to take the drug. I also found that a baked potato usually gave me no problems. I basicially ate meat, bread, and potatoes. Good luck and keep adjusting your diet. I took my last Tykerb Nov. 17th and within two days my stomach that I had had for a year completely disappeared. I am now eating fruit, veggies, and drinking more milk that I need. You will be too!!
Sandra
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Pathology Report: ER/PR-; HER2+ (3+); Grade 3, StageIII; 3cm tumor plus 21/21 lymph nodes positive; 5cm DCIS
Chemo: A/C; Taxol/Herceptin/Tykerb; phase II study at Mayo adding Tykerb for early stage
Radiation: 25 rads
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Old 01-03-2010, 09:05 PM   #25
TSund
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Re: Neratinib Clinical Trial

Kriss,

Ugh. Hang in there!

Kind of an odd "blind" trial when the side effects are so evident. Did you react upon the very first dose? How many doses did you take?

Wishing you luck,

TRS
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 01-08-2010, 10:56 AM   #26
KRISS
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Re: Neratinib Clinical Trial

I took the 1st dose at bedtime and the symptoms started first thing in the morning. By the 3rd day it was unbearable. They started me again on Monday and dropped my dose to 200mg. I started the lomotil at the same time. this time around it is not as bad but still not great. The diarreah started immediately but only maybe 8 or 10 times a day. I changed my diet again using some of the guide lines Steph had tried and think it is all helping. I feel very fortunate to be part of the trial and am pretty confidant that I am getting the real thing. But honestly I am just so pleased that I can give back or pay it forward. I know without all those brave women that were part of the herceptin and many other trials I may not be here to do this. So I will take the diarreah and all the other stuff. Have a blessed day ladies.
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DX IDC AT 42 12/7/06
2.2CM STAGE I GRADE 2
NODE NEG
PARTIAL 12/18/06
HER2+ /ER+(75%) PR+(5%)
4 DD AC CHEMO STARTING 1/10/07
4 DD Taxol Starting 3/5/07
1year weekly Herceptin starting 3/5/07
finished 2/18/08
changed to every 3 weeks 4/23/07
completed 33 radiation treatments 7/6/07
TAH and BSO 9/24/07
start Femarra 10/8/07
Started Neritinib trial 12/14/09
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Old 01-08-2010, 12:10 PM   #27
KristyAnn
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Re: Neratinib Clinical Trial

Kriss,
I started the trial on Oct 7 and have the violent side effects like you did AND I ended up with severly depleted potassium and magnesium from the diarrhea. They found all that at my 1 month appointment and I spent the next two months trying to get potassium and magnesium back to normal and going through dose reduction.
I reduced to 200 mg and have almost as violent a reaction as the 240 mg, uncontrollable diarrhea with lomotil and immodium and still had problems with potassium and magnesium.
I got reduced again to 160 mg and it has been a WORLD of difference- I think we finally found a dosage my body can handle!!!!!

Talk to your nurse if it is still that bad- she should have the guidelines to get you to a dose that is tolerable!

Kristy
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Old 01-08-2010, 02:20 PM   #28
KRISS
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Re: Neratinib Clinical Trial

Wow, at least I know I'm not alone. I have my 1 month on the 18th and am very interested to see what my levels are. Will the increase your dose again after some time or will you always stay at the 160mg? I would find it ineresting to see if the body starts to tolerate it. Thanks for sharing Kristy Ann and good luck to you!
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DX IDC AT 42 12/7/06
2.2CM STAGE I GRADE 2
NODE NEG
PARTIAL 12/18/06
HER2+ /ER+(75%) PR+(5%)
4 DD AC CHEMO STARTING 1/10/07
4 DD Taxol Starting 3/5/07
1year weekly Herceptin starting 3/5/07
finished 2/18/08
changed to every 3 weeks 4/23/07
completed 33 radiation treatments 7/6/07
TAH and BSO 9/24/07
start Femarra 10/8/07
Started Neritinib trial 12/14/09
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Old 01-09-2010, 07:41 AM   #29
TSund
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Re: Neratinib Clinical Trial

Are you allowed to take supplements during this trial? Perhaps a regimine of really good probiotics would help some. I'm not certain of the mechanism of this diarreha, but usually it is caused by an upset of the natural flora of the digestive system.
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 01-09-2010, 09:56 AM   #30
KRISS
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Re: Neratinib Clinical Trial

becuase I have not been eating well during this I tried to take supplements as well as Ensure. Both caused be to vomit which I never did during chemo! I always thought I was pretty tough but this is literally kicking my butt! I will talk to the nurse Monday and see what she says about using pro bi's. I'm a zookeeper and we have several animals under my care on them. Maybe I should see if they want to share.
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DX IDC AT 42 12/7/06
2.2CM STAGE I GRADE 2
NODE NEG
PARTIAL 12/18/06
HER2+ /ER+(75%) PR+(5%)
4 DD AC CHEMO STARTING 1/10/07
4 DD Taxol Starting 3/5/07
1year weekly Herceptin starting 3/5/07
finished 2/18/08
changed to every 3 weeks 4/23/07
completed 33 radiation treatments 7/6/07
TAH and BSO 9/24/07
start Femarra 10/8/07
Started Neritinib trial 12/14/09
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Old 01-09-2010, 10:53 AM   #31
TSund
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Re: Neratinib Clinical Trial

I also wonder if L-Glutamine would help; it is good for the stomach lining. Ruth took bentonite (clay?) at the early stages of her chemo. It held off the diarreha longer than others however she eventually had to move to some imodium as well.

A zoo keeper! How wonderful!!
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.

Last edited by TSund; 01-09-2010 at 10:58 AM..
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Old 01-09-2010, 10:57 AM   #32
TSund
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Re: Neratinib Clinical Trial

...and, is this something causing acidity like chemo does? Ruth would have been lost without her Omprazole during chemo, I wonder if something like this would help.
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 01-11-2010, 12:54 PM   #33
KristyAnn
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Re: Neratinib Clinical Trial

Im not sure of the mechanism of the diarrhea but nothing I tried could control it. IF you have side effects on neratinib they normally tell you to eliminate dairy as it seems to make everything a lot worse- and that was true for me.

160 mg is great- I had a weekend with no diarrhea this past weekend- first time since I started the trial in early October.

Kriss, There is a protocol for increasing the dosage back if it has been lowered - not sure of the "rules" but my nurse did say they probably would not try that with me because of the severity of the potassium and magnesium problems and their implications.

Kristy
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Old 01-11-2010, 01:15 PM   #34
DanaRT
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Re: Neratinib Clinical Trial

I am watching this thread frequently. Not responding much though.
Kristy, Glad things have settled down. Is that 160 mg per day or twice a day?
Kriss, a zookeeper! Exciting. Maybe the ensure is too rich on an empty stomach. I would be tempted to not eat if the diareha (sp?) were a problem.

I think I would be a good candidate for this trial. At first my onco didn't think I qualified because I am NED. That's a criteria, hello....will know soon. My next appointment is 1-22.

Hang in there all and thanks for reporting.

Love,
Dana

P.S. My hair is now as long as Kriss'. I should learn how to post a new picture...
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Diagnosed - Nov. 2, 2007 at 45
Lumpectomy - Nov. 13, 2007
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Stage 1 Grade 3
ER/PR - Her2 +++ (3.8)
Taxotere/Carboplatin/Herceptin- 6 rounds
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Old 01-12-2010, 01:41 PM   #35
KristyAnn
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Re: Neratinib Clinical Trial

I take the 160 mg all at once in the morning!

3 normal days in a row- this looks promising!

Kristy
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Old 01-12-2010, 04:19 PM   #36
Patty F
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Re: Neratinib Clinical Trial

Kristy
Glad things are going better for you. I take 240 mg but I find I have less symptoms if I take them at night. Still have trouble with the diarrhea but nothing like you have had.
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11/07 - 1/08: AC
1/30/08: Right Mast Stage lllC
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Old 01-14-2010, 08:37 PM   #37
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Re: Neratinib Clinical Trial

I enrolled on Tuesday and am on day three of the pills at the 240 mg dose. First day just a little light-headedness. Audible gurgling in my belly at night. Yesterday a bit of nausea while working out but all seemed like they could be psychosomatic because I so don't want to be in the placebo group.

Day 3, the diarrhea began! Two immodium at onset and another with each loose movement that followed. Not a ton of cramping. Just had dinner and am wondering if I'm in the clear for the rest of tonight. Sure hope so.

Nice to know I'm not alone in this, as always.
xo
cary
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IDC, grade 3, Stage III
ER+ PR- Her2+++
9 nodes +
DD AC/T
Tried lumpectomy 2x Failed
Bilateral Mastectomy 3/07
Radiation 33x
Lupron + Tamoxifen for 3 months
Herceptin started 6/07
Ooph + Femara 7/07
Zometa
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Old 01-15-2010, 06:03 AM   #38
KRISS
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Re: Neratinib Clinical Trial

Well I'm on day 12 of my resart at 200mg and for the last 2 days my life has been almost normal. Only going to the bathroom 2x a day. Wow. I take my pills at night as well Patty. See the doc on Monday and am interseted to see if they will bump me back up to 240mg. But everyone hang in there and think of all the good we are doing not only for ourselves but for countless others. Have a blessed day!
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DX IDC AT 42 12/7/06
2.2CM STAGE I GRADE 2
NODE NEG
PARTIAL 12/18/06
HER2+ /ER+(75%) PR+(5%)
4 DD AC CHEMO STARTING 1/10/07
4 DD Taxol Starting 3/5/07
1year weekly Herceptin starting 3/5/07
finished 2/18/08
changed to every 3 weeks 4/23/07
completed 33 radiation treatments 7/6/07
TAH and BSO 9/24/07
start Femarra 10/8/07
Started Neritinib trial 12/14/09
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Old 01-17-2010, 03:21 AM   #39
carykim
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Re: Neratinib Clinical Trial

Took so much immodium on day 3 (when the diarrhea first started) that I was stopped up and bloated day 4.

Day 5 I was back to wishing for diarrhea to get some relief from the unbearable constipation! Careful what you wish for. It started right after dinner last night, but I figured I'd wait to start the immodium in case it was a one time bout. Ha. Had three more "experiences" in the bathroom and took 2 immodium, then one more with the next loose movement and passed out from exhaustion.

It's 2 in the morning on Day 6, and I'm up with that gurgling belly that's been a precursor to the runs each time. I wonder how long I can last on this constipation-diarrhea roller coaster.

I did also get dry heaves and severe hiccups on day 4 when I had the post-immodium-overdose constipation. Almost as if being stopped up on the bottom was forcing it to try to come up instead, but it was too far down my digestive tract.

I wonder if this would be happening if it was delivered via infusion like Herceptin? Maybe oral is just not an ideal pathway?

Terri--you mentioned bentonite clay. How much did Ruth take? I'm gagging at the thought of ingesting that powder, but at 2AM with the gurgling getting louder, I'm desperately eyeing the container in my medicine cabinet. It's labeled for face mask (beauty product) but is pure clay. Perhaps Ruth had it in pill form--that would make more sense.

KristyAnn--any physical symptoms of potassium/magnesium deficiency? or it just shows up on blood work?

Kriss--Looking forward to a report of your appointment this week and the results of the blood work. This is your first blood draw, right?
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DX @ 34, Oct 2006
IDC, grade 3, Stage III
ER+ PR- Her2+++
9 nodes +
DD AC/T
Tried lumpectomy 2x Failed
Bilateral Mastectomy 3/07
Radiation 33x
Lupron + Tamoxifen for 3 months
Herceptin started 6/07
Ooph + Femara 7/07
Zometa
Neratinib Trial 1/10
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Old 01-17-2010, 05:56 AM   #40
Ellie F
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Re: Neratinib Clinical Trial

Thanks to you all for putting up with these side effects. You are bringing hope to the rest of us.
love Ellie
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