HonCode

Go Back   HER2 Support Group Forums > Clinical Trials
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 09-06-2009, 03:39 PM   #1
DanaRT
Senior Member
 
DanaRT's Avatar
 
Join Date: Dec 2007
Location: Avilla, Indiana
Posts: 261
Neratinib Clinical Trial

I was wondering if anyone has been involved with this clinical trial for early stage Her2+ breast cancer survivors.

http://clinicaltrials.gov/ct2/show/NCT00878709

Thank you.
Dana
__________________
-Dana-

]
Diagnosed - Nov. 2, 2007 at 45
Lumpectomy - Nov. 13, 2007
Tumor 1.2 cm
Stage 1 Grade 3
ER/PR - Her2 +++ (3.8)
Taxotere/Carboplatin/Herceptin- 6 rounds
Neulasta
Radiation 33 treatments - will be done 6/6/08
Herceptin through 12/08
12/07 MUGA 61%, 4/08 MUGA 60%, 7/08 MUGA 64%
three wonderful daughters, a terrific husband,
Life is Good
DanaRT is offline   Reply With Quote
Old 09-08-2009, 10:12 PM   #2
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

I just started this study on 9-1. So far so good. I still dont know if Ive got the drug or placebo.
Cranegirl is offline   Reply With Quote
Old 09-09-2009, 04:24 AM   #3
DanaRT
Senior Member
 
DanaRT's Avatar
 
Join Date: Dec 2007
Location: Avilla, Indiana
Posts: 261
Re: Neratinib Clinical Trial

Hi Cranegirl, Thanks for responding. Is this an IV administered or pill form? Did you go through a lot of testing to make sure you were eligible?
What part of the country do you live?

Love,
Dana
__________________
-Dana-

]
Diagnosed - Nov. 2, 2007 at 45
Lumpectomy - Nov. 13, 2007
Tumor 1.2 cm
Stage 1 Grade 3
ER/PR - Her2 +++ (3.8)
Taxotere/Carboplatin/Herceptin- 6 rounds
Neulasta
Radiation 33 treatments - will be done 6/6/08
Herceptin through 12/08
12/07 MUGA 61%, 4/08 MUGA 60%, 7/08 MUGA 64%
three wonderful daughters, a terrific husband,
Life is Good
DanaRT is offline   Reply With Quote
Old 09-15-2009, 09:37 AM   #4
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

Hi DanaRT, Sorry its been a few days. I was out of town. The drug is delivered in pill form. 240 mg is the dose. Right now its six pills a day but soon a 240 mg pill will be available. I had to do a few tests to qualify for this study. A muga, a mamo, an EKG, chest Xray and some blood work. I believe you had to have taken Herceptin within two years of starting the study. There are a few side effects to the drug, the main one being diarrhea, so I thought for sure Id know if I was recieving the drug or the placebo. But so far Ive only had a consistant headache. Ive had a few other symptoms but Im not sure if its a side effect or I am attributing everything on the drug. I was the queen of side effects with TCH and Herceptin but if this is the Neratinib its been very easy. I live in southern California and Im doing the study with Breastlink Research and Dr. Waisman.
Cranegirl is offline   Reply With Quote
Old 09-15-2009, 01:42 PM   #5
Julie2
Senior Member
 
Join Date: Sep 2005
Posts: 556
Re: Neratinib Clinical Trial

Hi Cranegirl,

I heard good things about this drug. Congrats for participating in the trial. May I know what stage are you?

Thanks,
Julie
__________________
Diagnosed in Sept 2004 while pregnant with the second child. Stage 3b, tumor 4.5cm, 4 auxillary and supraclav node positive. Her2+++ FISH 9.4 and er-,pr-.
Had dose dense neoadjuvant AC,Taxol then mastectomy,radiation+xeloda+Herceptin.
Julie2 is offline   Reply With Quote
Old 09-20-2009, 06:03 PM   #6
DanaRT
Senior Member
 
DanaRT's Avatar
 
Join Date: Dec 2007
Location: Avilla, Indiana
Posts: 261
Re: Neratinib Clinical Trial

Dear Cranegirl, Glad to hear from you again. My onco told me last week that I do not qualify since I am done with treatment and am NED. I hope you're doing well with the trial. Keep us posted. How long will you be involved with it?
__________________
-Dana-

]
Diagnosed - Nov. 2, 2007 at 45
Lumpectomy - Nov. 13, 2007
Tumor 1.2 cm
Stage 1 Grade 3
ER/PR - Her2 +++ (3.8)
Taxotere/Carboplatin/Herceptin- 6 rounds
Neulasta
Radiation 33 treatments - will be done 6/6/08
Herceptin through 12/08
12/07 MUGA 61%, 4/08 MUGA 60%, 7/08 MUGA 64%
three wonderful daughters, a terrific husband,
Life is Good
DanaRT is offline   Reply With Quote
Old 09-21-2009, 11:39 AM   #7
SuzEQ
Member
 
Join Date: Jun 2009
Posts: 7
Re: Neratinib Clinical Trial

My understanding of the trial is 50% get the drug 50% get placebo. The drug has a high rate of diarrhea but can be controlled. You have to be within 2 years of your last chemo to qualify so there is some time for those of us who may not be sure if this is the right trial, especially since 50% get placebo. I'm currently on a bisphosphonate trial which addresses the ER+ aspect of this disease but I do want to be sure the Herceptin took care of the Her2+ part as well. Of course, I can only participate in one trial at a time (and don't want to risk being in the placebo group) but I'm curious if other similar trials targeting Her2 will open soon. Anyone have info. on the vaccine trials for early stage? My onc is not too optimistic about the vaccine approach working, I'll ask more on why next time but if others have discussed other trials for early stage disease with their oncs, I am interested in hearing more. Thanks.
SuzEQ is offline   Reply With Quote
Old 09-22-2009, 05:30 PM   #8
mnts1day
Junior Member
 
Join Date: Sep 2009
Posts: 1
Re: Neratinib Clinical Trial

DanaRT,

I believe your onc could be wrong. I see you had Herceptin until 12/08, that would make you eligible for the Neratinib Clinical Trial as I understand they want participants who have completed Herceptin treatment within 2 years. That would mean you have until 12/2010 to make up your mind. Also, you must be NED.
mnts1day is offline   Reply With Quote
Old 09-22-2009, 05:46 PM   #9
DanaRT
Senior Member
 
DanaRT's Avatar
 
Join Date: Dec 2007
Location: Avilla, Indiana
Posts: 261
Re: Neratinib Clinical Trial

Thanks, mnts1day, I am going to print some information and send it to the research nurse. I am NED but have never had any scans. Will let you know what I find out in the next two weeks.

I like the fact that it's a pill and not an IV. My post has been gone since February.
__________________
-Dana-

]
Diagnosed - Nov. 2, 2007 at 45
Lumpectomy - Nov. 13, 2007
Tumor 1.2 cm
Stage 1 Grade 3
ER/PR - Her2 +++ (3.8)
Taxotere/Carboplatin/Herceptin- 6 rounds
Neulasta
Radiation 33 treatments - will be done 6/6/08
Herceptin through 12/08
12/07 MUGA 61%, 4/08 MUGA 60%, 7/08 MUGA 64%
three wonderful daughters, a terrific husband,
Life is Good
DanaRT is offline   Reply With Quote
Old 09-28-2009, 08:35 AM   #10
Brenda_D
Senior Member
 
Join Date: Jan 2007
Posts: 368
Re: Neratinib Clinical Trial

To the ladies in this trial, do you have to go to the cancer center to get your pills or do they send them to you?
Who pays for the scans and pills?
__________________
12/12/06- IDC Stage III, 4x A/C, 35 rads, Herceptin 1 year
Brenda_D is offline   Reply With Quote
Old 10-04-2009, 07:39 AM   #11
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

You go get the pills in a months supply at your Dr. visit. The Study pays for everything.
Cora
Cranegirl is offline   Reply With Quote
Old 10-04-2009, 01:52 PM   #12
TSund
Senior Member
 
TSund's Avatar
 
Join Date: May 2007
Location: DFW area (TX)
Posts: 431
Re: Neratinib Clinical Trial

Ruth has been asked if she wants to participate in this trial. She is really, really torn. She is so ready to be DONE.

As I understand it, this drug is similar to Herceptin but will cross the blood/brain barrier, unlike Herceptin. This is possibly a huge plus. Feels to me like a bigger "punch" than the AI treatment she is currently on. (will switch in 6 months from Tamaxifen to Arimidex or Femara)

Does anyone know more about this drug or the studies that have been done so far?

I even wonder if she might be better choosing this trial than to endure the Arimidex/Femara AI side effects. If she gets the diarreha she can be pretty darn sure she doesn't have the placebo. I realize they do not target the same receptors, but certainly it's the HER2 that's the much bigger issue, yes?

Thank-you for any replies.
__________________
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; 10-04-2009 at 01:56 PM..
TSund is offline   Reply With Quote
Old 10-06-2009, 06:03 PM   #13
Sandra in GA
Senior Member
 
Join Date: Aug 2009
Location: Moultrie, GA
Posts: 431
Re: Neratinib Clinical Trial

Is this drug similar to Tykerb (lapatinib)?
__________________
Diagnosed: 7/25/08 ~ age 63, no family history
Surgery: 8/14/08 Bilateral mastectomy; tumor left breast, node dissection; right prophylactic with expanders: 1/12/10 latisimuss dorsi flap on left side: 9/22/10 implants in
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
Vaccine: Walter Reed GP2/AE37 vaccine study ~ last booster 9/17/2012
Sandra in GA is offline   Reply With Quote
Old 10-10-2009, 11:26 AM   #14
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

No, this drug is very similar to Herceptin but it is a smaller molecule and crosses over the blood brain barrier. Cora
Cranegirl is offline   Reply With Quote
Old 10-10-2009, 02:48 PM   #15
TSund
Senior Member
 
TSund's Avatar
 
Join Date: May 2007
Location: DFW area (TX)
Posts: 431
Re: Neratinib Clinical Trial

So how do the 3 compare to each other?


All 3 are biological drugs as opposed to chemo, correct?
__________________
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.
TSund is offline   Reply With Quote
Old 10-11-2009, 11:56 AM   #16
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

Good question. I'm going to ask the study Dr. that.
Cora
Cranegirl is offline   Reply With Quote
Old 10-11-2009, 12:12 PM   #17
Mary Anne in TX
Senior Member
 
Mary Anne in TX's Avatar
 
Join Date: Jun 2006
Location: San Antonio, TX
Posts: 2,357
Re: Neratinib Clinical Trial

It got rave reviews and interest in San Antonio last December. I think I'll ask about it in Nov. when I see my onc. ma
__________________
MA in TX.
Grateful for each and every day....

Diag. 12/05 at age 60
Stage II, Grade 3, 4.5 cm primary tumor
ER/PR- Her2 +3 strongly positive
Her2 by FISH 7.7 amplified
vascular invasion
Ki67 20% borderline
Jan - March '06 Taxotere/Adriamycin X 3 to try to shrink tumor - it grew
April '06 Rt Modified Radical Mas, 7 of 9 nodes positive
April - Aug. '06 Herceptin/Taxol/Carboplatin X 8 (dose dense)
Sept - Dec. '06 Navelbine/Herceptin x 8 (dose dense)
Radiation & Herceptin Jan. 22 - March 1, 2007
Finished Herceptin Dec. 10 '08! One extra year.
Port removed August, 2012.
8 1/2 years since diagnosis! 5 1/2 Years NED!
Mary Anne in TX is offline   Reply With Quote
Old 10-13-2009, 03:28 PM   #18
Cranegirl
Member
 
Join Date: Jan 2008
Posts: 6
Re: Neratinib Clinical Trial

I got this from the nurse prac, my onc being too busy to call me back. Tykerb and Neratinib are very similar, both being a small molecule and crossing the blood brain barrier. Almost like sister drugs.
Cora
Cranegirl is offline   Reply With Quote
Old 10-13-2009, 04:48 PM   #19
Sandra in GA
Senior Member
 
Join Date: Aug 2009
Location: Moultrie, GA
Posts: 431
Re: Neratinib Clinical Trial

That is what I had assumed becuse they both seem to have similar side effects (diarrhea) as well as cross the the brain barrier. I was told that the Herceptin attacks the HER2 cells on the outside and the lapatinib (Tykerb) attacks the cells on the inside. From where I stand, it feels good to know that I am attacking them from almost all angles. Thank you for the info concerning Neratinid. I am unfamiliar with it.
Sandra
__________________
Diagnosed: 7/25/08 ~ age 63, no family history
Surgery: 8/14/08 Bilateral mastectomy; tumor left breast, node dissection; right prophylactic with expanders: 1/12/10 latisimuss dorsi flap on left side: 9/22/10 implants in
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
Vaccine: Walter Reed GP2/AE37 vaccine study ~ last booster 9/17/2012
Sandra in GA is offline   Reply With Quote
Old 12-19-2009, 06:07 AM   #20
KRISS
Senior Member
 
KRISS's Avatar
 
Join Date: Dec 2006
Location: WHITESTOWN IN
Posts: 148
Re: Neratinib Clinical Trial

I just started this trial on Monday and am not having that good of time. The diarrhea is uncontrollable for me even with prescription drugs. They say they will probably either cut my dose or take me off for a week and restart. I never had this much trouble with herceptin or chemo. Very glad to be taking part and giving back but this could be a very long year!
__________________
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
KRISS is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 07:15 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter