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Old 01-17-2010, 01:43 PM   #41
vlcarr
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Re: Neratinib Clinical Trial

I finally looked at where these trials are being done and they are doing this trial where I'm being treated. I'm going to talk to my onc when I go for my final chemo on 01/28. I will finish herceptin in June.

I don't know if I could do this or not since I did the Tykerb trial. Part of me says yes, but the other part says no.......

I had the potassium problem on the Tykerb but really didn't have the diarrhea issue that most people experience.

If I can do this one I know I feel torn about wanting this to all be over but also wanting to do what I can to help others and to avoid recurrence.....

My tumor was Grade III, and on some paperwork my onc did for my employer she said this about prognosis, "Tumor features are concerning for a very high risk of distant relapse". When I asked her what my odds are for a recurrence she said 15 to 20%. My FISH score was 6.31 (the report says HER-2/CEP 17 ratio) and I think someone her told me that is my FISH.

I've had severe stomach issues while on TCH and am so looking forward to those being gone and have not been able to work at all due to the side effects. I still have 6 1/2 weeks of radiation that will start around March 1st. I also realize I may not get the real thing if I do the trial. I was able to work while on the Tykerb trial.

I also could not afford to not work. I'm very fortunate that I've been able to keep my paycheck coming because so many people at work donated their annual leave to me. I received over 700 hours of donated leave through a program we have called leave sharing. I have over 25 years with my employer and traveled all over the country so a lot of people know me. I also joined another program we have called the leave bank so I can get an additional 240 hours from that when my donated leave runs out.

I know no one can tell me what to do but the point of my rambling is to ask those of you who've been fighting this battle longer than me for your opinion.

I had such great results with the Tykerb trial. Am also wondering if that would exclude me from this trial but they seem to be unrelated.

Wishing I had a crystal ball........
__________________
Vicky
Age 47, TN, Diagnosed 05/09
Her2+, ER/PR-, Stage III, 2 tumors = 1 8cm tumor
Grade 3
Sentinel Node Biopsy-speck present in 1 node
Completed 3 month clinical trial of weekly Herceptin and 1000mg Tykerb daily
Tumor no longer present
Right mastectomy and lymph node removal 09/25/09
No cancer present at time of surgery, none in lymph nodes
Start TCH 10/15, every 3 weeks for 4 months followed by radiation
Finished chemo 01/28/10-YEAH!
Herceptin every 3 wks until end of June
Radiation begins 03/01, 6 1/2 weeks
Radiation complete--Yeah!!
Developed lymphedema after radiation
In hospital for 4 days with pneumonia:(
Herceptin done! 06/24/10
Port Removed 07/08/10
Still in PT for lymphedema and mobility issues
DIEP Reconstruction 05/11
I can be changed by what happens to me, but I refuse to be reduced by it~~Maya Angelou
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Old 01-17-2010, 03:41 PM   #42
v-ness
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Re: Neratinib Clinical Trial

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
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8/09 - IDC 1.8 cm triple positive, lumpectomy left breast
10/09 began chemo (taxotere & carboplatin) and weekly herceptin.
1/21/10 finished chemo, continued on herceptin every 3 weeks until 10/2010.
2/10 began 7 wks of radiation
6/10 mom dies of primary peritoneal ovarian cancer
8/10 got my last remaining ovary out
10/10 mammogram all clear
3/11 MRI shows 5 'spots' in right breast, largest 1 cm unidentifiable on US
needle biopsy proved the largest to be old inflamed cyst -phew!
7/10 switched to Arimidex
8/9 switched to Femara - allergic to arimidex
Femara made me lose hair quickly so switched to Aromasin
Aromasin made my hair fall out too and the bone pain was too much.
back on Tamoxifen 1/2013.
blood clot from trains and planes 5/2014 so on coumadin per onco for as long as i am on tamoxifen
tamoxifen was supposed to be up with my 5 yrs in may but my boyfriend was diagnosed with stage 4 colon cancer so i am staying on tamoxifen indefinitely because i want some ammo against BC, given the stress. lost my husband in only 10 wks in 2007 to stage 4 esophageal cancer.
cancer's screwing with another man i love
2/2016 - 6yrs in remission, off tamoxifen and off coumadin - yay!
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Old 01-18-2010, 07:22 AM   #43
carykim
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Re: Neratinib Clinical Trial

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
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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
Neratinib Trial 1/10
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Old 01-24-2010, 04:15 PM   #44
DanaRT
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Re: Neratinib Clinical Trial

Well, I after talking with my onco at length we decided I would not be a part of this trial. I am somewhat relieved. I will keep reading this thread to see how you all are doing.

Love,
Dana
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-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
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Old 01-28-2010, 11:50 PM   #45
vlcarr
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Re: Neratinib Clinical Trial

Just wanted to let you know that I cannot do this trial. My participation in the Tykerb doesn't allow me to do this one. I'm still very happy I did the Tykerb trial and I will be cheering for all of you on this one.
__________________
Vicky
Age 47, TN, Diagnosed 05/09
Her2+, ER/PR-, Stage III, 2 tumors = 1 8cm tumor
Grade 3
Sentinel Node Biopsy-speck present in 1 node
Completed 3 month clinical trial of weekly Herceptin and 1000mg Tykerb daily
Tumor no longer present
Right mastectomy and lymph node removal 09/25/09
No cancer present at time of surgery, none in lymph nodes
Start TCH 10/15, every 3 weeks for 4 months followed by radiation
Finished chemo 01/28/10-YEAH!
Herceptin every 3 wks until end of June
Radiation begins 03/01, 6 1/2 weeks
Radiation complete--Yeah!!
Developed lymphedema after radiation
In hospital for 4 days with pneumonia:(
Herceptin done! 06/24/10
Port Removed 07/08/10
Still in PT for lymphedema and mobility issues
DIEP Reconstruction 05/11
I can be changed by what happens to me, but I refuse to be reduced by it~~Maya Angelou
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Old 02-05-2010, 04:07 PM   #46
KRISS
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Re: Neratinib Clinical Trial

Hello Ladies
Sorryit took me so long to tell you about my 1 month visit. Had a nasty infection that kept me in bed but doing great now. All my blood work looked great as well as my ekg. They kept me on the 200mg for a month and just this past Monday they upped me to 240mg. All is going well. I still have not had a normal stool and am starting to think I won't until I'm off of this but it's the least I can do. Hope you are all doing well. Keep us posted and I will do the same. Have a blessed day.
__________________
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 02-07-2010, 02:36 PM   #47
eva226
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Re: Neratinib Clinical Trial

Hi, my name is Eva. My doctor offered the Neratinib clinical trial. I was diagnosed with bc in March 2007. I had 8 sessions of chemo with ac/taxol, did 33 sessions of radiation and a yr of herceptin. I have been doing well, NED. I've been debating whether or not to join the clinical trial. Could anyone offer some advice?
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Old 02-09-2010, 03:04 PM   #48
Midwest Alice
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Re: Neratinib Clinical Trial

Hey, we have another sister who has started the process to get approved for this trial. JenniferS.

Praying for you as you proceed!

Keep us posted,

Alice
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Alice
04/08 age 50 III IBC Her2+++ ER/PR-8cm 14/14 Double M, Body and Brain CT/PET clear, ? on spine,Muga 53
06/08, 4 A/C, Neulasta
08/08, Herceptin/tax 12 every week
10/08, CT/PET clear, ? on pelvis, hips, MUGA 43, started Enalaprial for heart, Herceptin every 3 weeks
11/08 33Rads; 12/08 MUGA 48
2/09 MRI spine and bone scan, old mets to spine, Chest x-ray, blood work, IV NED,regular CPAP use,Zometa x6, first -flue like symptoms 2 days;Herceptin x3; stage 2 lymphoedema..sleeve and glove
4/09 Brain MRI - CLEAR; MUGA 54
7/09 chest ultrasound,
10/09 PET, brain and spin MRI NED Herceptin only. MUGA 59!!!
1/11 Hip replacement 7/11 Hip 2 replacement
4/12 4 years!! Herceptin
6/12 start reconstruction finish in 12/12
2/14 Herception - 6 years!!!

1 Corinthians 10:13 "No temptation has seized you except what is common to man. And God is faithful; he will not let you be tempted beyond what you can bear. But when you are tempted, he will also provide a way out so that you
can stand up under it."

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Old 02-18-2010, 10:48 AM   #49
Laya6680tx
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Re: Neratinib Clinical Trial

Hi Ladies,

Just wanted to get into contact because I recently started the Neratinib trial (7 days ago) and have also experienced severe side effects. Dehydration to the point that I had to leave work on my second day of a new job to get IV fluids from my onco nurses.

I was told to stop taking the pills until my stool is back to normal, then I will start taking 5 pills instead of 6. Initially my onco had me inject myself with an anti-diarrhea med because the Lomotil and Immodium did nothing to stop the floodgates after they were opened. Apparently, this injection (which stopped the diarrhea completely), isn't something they are using on the study to treat the side effects. So, I must start lowering the dose.

As it is, I don't eat meat; I cut out all dairy before I started because I was told what it may do to my system, so as far as diet goes, I'm pretty much existing on rice/beans and fruit. I understand how the anorexia side effect may become a problem. Hopefully, on a new dose, things won't be so bad.

Any dietary suggestions are appreciated Thanks!

~Bethany
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"Hope is definitely not the same thing as optimism. It is not the conviction that something will turn out well, but the certainty that something makes sense, regardless of how it turns out." - Václav Havel

Dx: 6/08 at 27. 1.8 cm, 0/3 nodes. Triple positive, BRCA negative.Tx: Lumpectomy. Chemo TCH, 35 Rads, Tamox & Zoladex. Currently on Neratinib trial.
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Old 02-19-2010, 06:16 AM   #50
KRISS
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Re: Neratinib Clinical Trial

Hang in there Bethany. I did well on the 5 pill dose and in fact going to ask to go back to that. Tired of feeling "not right". The GI system is constantly on the go making noises and causing discomfort. Oatmeal has become one of my favorite things. I seem to keep it in my system longer than anything else. Keep us posted. I was feeling normal within 48 hours of stopping the drug so I hope you are too!
__________________
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 03-01-2010, 07:00 PM   #51
1rarebird
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Re: Neratinib Clinical Trial

I posted this question at BC.org but haven't yet received any feed back. Maybe my luck will be better here.

I believe I read somewhere that Neratinib possibly may help prevent "cross talk signaling" between the Her1 and Her2 receptors, or the Her1 or 2 receptors and ERs. If this is true, could it be part of why Her2+ cancers can sometimes exhibit resistance to trastuzumab (Herceptin), and would Neratinib or even Laptinib help prevent such cross talk between (among) the receptors?

I don't know if this trial's investigators are looking at this question too. This is complicated stuff for me to understand, but if the anti-cross-talk question is valid, it may give another reason to sign up for the trial.

Thanks

bird

Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH, radiation, Tamoxifen therapy planned

Last edited by 1rarebird; 03-01-2010 at 07:55 PM.. Reason: add signature
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Old 03-02-2010, 03:10 PM   #52
KristyAnn
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Re: Neratinib Clinical Trial

I have heard that too- all I really understand is that Herceptin blocks Her2 and neratinib blocks other HER receptors. My onc mentioned that many times when they have a HER2+ person with a recurrence after herceptin, further testing shows there is also an abundance of other HER receptors (like Her3 and 4) and that neratinib may also block those.
Kristy
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Old 03-03-2010, 06:41 AM   #53
1rarebird
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Re: Neratinib Clinical Trial

Thanks, Kristy--
I am glad to see that the chemo-brain didn't affect my memory that badly after all and that I wasn't imagining things regarding the cross-talk issue. I will keep looking in my files to find the actual paper on this.

I met with my oncologist again 2 days ago and he said that our treatment center is almost finished with the paper work to get approval so it can participate in this trial. He also mentioned that accrual is going well for the trial so far, but that due to the numbers (3500 or so) patients that are being recruited, he expected it to remain open for a couple more years. That should leave me ample time to get on on the trial after I am done with the Herceptin this July.

bird
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Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, 1.7 cm, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH finished 7/19/10, radiation 6 wks., Tamoxifen on going, bisphosphonate 24 mos.
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Old 04-10-2010, 09:59 AM   #54
freyja
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Re: Neratinib Clinical Trial

Hey ladies and gentlemen,
Don't know if you remember but I was approved for this trial way back in January but my treatment center somehow were prevented from starting it for some technicality. Now they are back on board, and I should start in a couple weeks when we got all the scans and tests redone. I'll be here reporting on the progress.
Celeste
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"Dancers Against Cancer" in the Eugene, OR Komen Race for the Cure 2010
Diagnosed 8/7/08 with stage 3 invasive ductal carcinoma, micropapillary pattern, Her2 3+, ER+,PR-, grade II, positive lymph nodes.
Received 6doses of Taxotere, Carboplatin with Herceptin continuing for a year...DONE.
1/28/09 Left Modified Radical Mastectomy, Right Simple Mastectomy.
Surgery pathology: No invasive carcinoma present and 17 lymph nodes removed all negative! Only small amount of carcinoma in situ in left breast.
March/April '09, Radiation to left chest wall.
Currently involved in Neratinib clinical trial.

"Well being I won
and wisdom too,
I grew and joyed in my growth;
from a word to a word
I was led to a word
from a deed to another deed." (Odin)

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Old 04-10-2010, 08:49 PM   #55
Patty F
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Re: Neratinib Clinical Trial

Celeste...welcome to the trial. I am almost at the 6 month mark. Still have diarrhea daily but not as bad as it was when I first started. Just had a muga and ekg Thursday and I find out the result on Tuesday when I see the clinical trial Dr.
__________________
10/15/07: Diagnosed at age 46 lymph node removal (2)
ER/PR - Her2 +++
11/07: Port Installed
11/07 - 1/08: AC
1/30/08: Right Mast Stage lllC
2/28/08: Start Taxol and Herceptin weekly.
5/15/08: Finished Taxol
8/12/08: Finished 33 Rads
1/29/09: Finished Herceptin
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Old 04-23-2010, 10:03 PM   #56
weety
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Re: Neratinib Clinical Trial

I have heard on another breast cancer site that they have amended this trial and are no longer accepting patients that have node-negative disease.
__________________
Diagnosed 7/09 with 7mm IDC ER weakly +, PR -, Her2+

TCH chemo 8/09-12/09

Ooph/hysterectomy 4/10

Started Femara 6/10

Completed year of herceptin 10/11

Zometa 1/11 (2X/yr for 2yrs)

Hopefully nothing else!!!!
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Old 04-24-2010, 06:17 PM   #57
freyja
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Re: Neratinib Clinical Trial

I am doing the scans Tuesday and should start in the next week or so. I didn't hear anything about an amendment. I was positive for lymphatic involvement when I was biopsied, though.
__________________

"Dancers Against Cancer" in the Eugene, OR Komen Race for the Cure 2010
Diagnosed 8/7/08 with stage 3 invasive ductal carcinoma, micropapillary pattern, Her2 3+, ER+,PR-, grade II, positive lymph nodes.
Received 6doses of Taxotere, Carboplatin with Herceptin continuing for a year...DONE.
1/28/09 Left Modified Radical Mastectomy, Right Simple Mastectomy.
Surgery pathology: No invasive carcinoma present and 17 lymph nodes removed all negative! Only small amount of carcinoma in situ in left breast.
March/April '09, Radiation to left chest wall.
Currently involved in Neratinib clinical trial.

"Well being I won
and wisdom too,
I grew and joyed in my growth;
from a word to a word
I was led to a word
from a deed to another deed." (Odin)

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Old 04-27-2010, 03:47 AM   #58
Savta
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Re: Neratinib Clinical Trial

Hello to all of you.
I have just been asked to participate in the Neratinib trials as well. I, of course, do not know if I will be receiving the drug or the placebo. But I wanted to ask those of you who are receiving the drug--how soon do you start with the side effects? I understand that side effects are generally controlable, but I wanted to know more or less what to expect.
I'm glad to have the chance to participate--and hope I get the real thing. Wish me luck!!!
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Old 04-27-2010, 09:29 AM   #59
Sandra in GA
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Re: Neratinib Clinical Trial

Savta,
I wish you luck with the Neratinib trial. I was in a phase II study of lapatinib (Tykerb) for early stage breast cancer at Mayo clinic. I took the lapatinib along with the Herceptin for a year. From what I have been able to determine it is a "first cousin " of Neratinib and has similar side effects; diarrhea, some problems involving the toes and fingers, etc. I found that if I ate a low fiber diet and stayed away from milk products, I could control the diarrhea somewhat. I still had to take Imodium and Lomotil along. However, it wasn't anything I could not live with. For the first 12 weeks I also had Taxol which I think contributed to some of my problems. Good luck to you! I am very glad I had the lapatinib. I hope you get some side effects~ that should mean you are getting the real drug!

Sandra
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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
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Old 04-29-2010, 11:04 AM   #60
Savta
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Re: Neratinib Clinical Trial

So, today I officially joined the Neratinib trial. Seeing as I only took the pills 9 hours ago, I guess I can't determine anything out of the ordinary. My doctor told me there are some that get the real drug and don't have side effects, so that it doesn't mean that I am necessarily getting the placebo if I feel nothing. I'm hoping for the best. And keeping in mind, even if I am on the placebo--that is also a contribution to the study.
Anything to lick this son of a gun!!!
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