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07-13-2010, 10:23 AM
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#1
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Senior Member
Join Date: Dec 2006
Posts: 415
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Anyone applied/enrolled in TDM1 EAP?
Hi Friends~
Just wondering if anyone has already applied or is enrolled in one of the TDM1 Extended Access programs?
I won't be eligible until August 3rd (60 days after Novalis for brain met) and am hoping the site in Nashville will have a spot open for me at that time.
In the meantime, I have my 1st follow up brain MRI tomorrow and am hoping and praying for some good news there. Then repeating treatment to my liver, probably RFA on 7/20.
I'm also really hoping that now that I'm officially off Ixempra, those nodes in lungs & belly that started showing activity again don't go crazy.
I really need to get on TDM1. I don't know that we have any other options, so I'm trying hard to stay positive but it'll be at least 3 weeks before I could start, if all goes well.
I hope that FDA approval comes through soon for all of us.
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07-13-2010, 12:12 PM
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#2
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Senior Member
Join Date: Oct 2009
Posts: 46
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Re: Anyone applied/enrolled in TDM1 EAP?
A friend of mine is on the EAP in California. I would suggest contacting the folks in Nashville directly yourself. Perhaps you can get started with the paperwork and everything else so that in 60 days you are ready to roll and don't have a further delay.
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07-13-2010, 04:01 PM
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#3
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Senior Member
Join Date: Oct 2005
Posts: 3,519
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Re: Anyone applied/enrolled in TDM1 EAP?
I am still waiting for a location to open in Texas... hear rumors about Seattle and Chicago, but they haven't officially announced them yet.
Best of luck, JML!
__________________
Brenda
NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)
Nov'03~ dX stage 2B
Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg
Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~ Started Tykerb/Xeloda, no WBR for now
June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~ PET/CT & MRI show NED
Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.
"I would rather be anecdotally alive than statistically dead."
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07-13-2010, 07:26 PM
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#4
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Senior Member
Join Date: Jan 2008
Location: Evergreen, Colorado
Posts: 454
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Re: Anyone applied/enrolled in TDM1 EAP?
Dear Jessica,
Best of luck with upcoming scans, I want you to know that I will be thinking of you during this next week.
I agree with JB...there is always so much paper work that if you can start the process, you could be on the plane to Nashville on August 3rd.
Also....doesn't it make you feel better to be actively "doing" rather than waiting.
Are you in Hawaii right now??? Hopefully enjoying friends and family.
Please let us know how things go...we are all pulling for you.
Hugs with an extra dose of energy....Lori
__________________
2007
Oct - Diagnosed - Stage IV 5 c.m. IDC - Left Side er/pr- Her2+++ Node + 2/14 - Single Liver Met Double Mastectomy Nov - Begin T+H 2008
Feb-Complete 6 cycles- T&H- NED
March - Continue - Herceptin Only
April - Rads for 6 weeks
2009
Continue Herceptin - Continue NED
April - Recurrance- 3 cm. Liver Met
May - Cryosurgery
June - November - Abraxane + Herceptin
Aug - PET/CT - CTC = 0 Back to NED
2010
January - Continue NED
July - Recurrance - 3 cm Liver Met CTC=1
August - Cryosurgery #2
August - November Navelbine
November - Back to NED - End Navelbine
2011
Feb - Recur - 4 cm Liver Met - Same Left Lobe
March Surgery it is -Couldn't get a clean margin
July - Confirmed continued liver involvement
August - Begin Herceptin + Tykerb
October - Mixed results from H+T
Add Abraxane + H + T - Nov - April
2012
January PET Scan - It's working!!
April - Back to NED
July - Recurrance
August - Begin TDM-1 Trial (Taxol + TDM-1)
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07-16-2010, 12:06 PM
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#5
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Senior Member
Join Date: Dec 2006
Posts: 415
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NED in the head Re: Anyone applied/enrolled in TDM1 EAP?
I have some GREAT news to share.
I had my follow up brain MRI on Wednesday and saw the Neuro Onc immediately after to discuss the results.
He said the MRI shows the spot has completely resolved, in fact, he wasn't even sure where he was supposed to look to even see the original spot.
He had to refer to the old MRI, then look back at the new one to compare, and said if anything at all, there's a tiny dot, but nothing he would have even noticed.
This is the good news that we have been hoping and praying for, and now we can work on applying for TDM1. My sister and my onc have already gotten the wheels in motion, so hopefully by August 3rd we can get started without any other delays.
In the meantime, I'm feeling stronger everyday since finishing Ixempra, and getting the blood transfusion. I'm scheduled to repeat the chemo embo on Wednesday to knock back the liver lesions and decrease the tumor load.
My mom's gone back to Hawaii  after 6 weeks of looking after me. I'm so sad and just miss her company and honestly, I'm feeling scared & unsure of if/how to even take care of myself. I've lost a lot of weight and muscle mass and my energy is still not great. I just have to be patient and give my body a chance to recover and heal and get strong again.
We hope that I'll be able to get to Hawaii soon, maybe after my 1st dose of TDM1, to rest and be with my family.
My dad's having heart valve replacement surgery on the 27th, so my mom will have her hands full again taking care of him. I hope I can be there to help too.
Life's road has been quite bumpy for the past few months, so I'm praying that things will mellow out now and give us a well deserved break.
Thanks so much for all your support everyone~
Keep the Faith
Jessica |
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07-16-2010, 12:47 PM
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#6
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: Anyone applied/enrolled in TDM1 EAP?
Hey Jessica,
What a fabulous report - don't you just love it when they can't even figure out where to look???? That's great news!
Yes, you have been bearing a lot over the past few months - you must be a very strong person to have been "given" all that burden to carry.
I saw a typo in your post of a few minutes ago...
""I'm so sad and just miss her company and honestly, I'm feeling scared & unsure of if/how to even take care of myself""
I know the "if" part was the fatigue talking, and the missing mom...
You know what to do. Try to get some nourishment - even if you have to go slowly, eat clean; maybe some smoothies with a good dose of protein powder. Try to move around a little - just short walks if you can, to start.
You're right, you deserve a break...hang in there my dear!
__________________
Chris in Scotts Valley
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
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07-16-2010, 08:40 PM
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#7
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Senior Member
Join Date: Jun 2009
Posts: 343
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Re: Anyone applied/enrolled in TDM1 EAP?
Hi Jessica,
I'm not sure where you live but I live in Nashville and saw that you may be coming here for the TDM1 trial. If you don't have any family/friends here I would be more than happy to do anything for you that I can. Seriously, I mean anything at all. Feel free to message me if I can be of any help. I'm not familiar with the trial or how long you will be here, etc but I just finished my year of treatment and had my port removed last week.
Wishing you the very best of luck.
Vicky
__________________
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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07-17-2010, 04:39 AM
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#8
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Senior Member
Join Date: Sep 2005
Location: MN
Posts: 731
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Re: Anyone applied/enrolled in TDM1 EAP?
Jessica -- The good news you've been waiting for & deserve - clean MRI!!! I'm so happy for you. Now to rest, eat well, take good care of yourself, rest more, and prepare for t dm1 when you can get it set up. I'm thinking of you daily. Pam
__________________
Pam
6/01 IBC er+ her2+stage IIIb; mastecomy
7/01 AC, taxol; radiation
2/02 tamoxifen
9/02 stage IV bone mets femara
1/03 taxotere/herceptin/aredia
6/03 herceptin, aredia & faslodex
1/04 navelbine, herceptin, aredia
2/05 herceptin/aredia
7/05 xeloda/herceptin/aredia
3/07 xeloda/tykerb/aredia
5/08 taxol/avastin/aredia
2/09 gemzar/herceptin/zometa
7/09 Taxol/Carbo/Herceptin, zometa
10/09 navelbine/herceptin & zometa
2/10 herceptin & tykerb & zometa
4/10 add xeloda &aromasin
10/10 dx with dermatomyiositis triggered by cancer
11/10 restart herceptin, tykerb, zometa
12/10 surgery-place rod in R femur to stabilize bone
1/11 radiation to R femur - 20 tx
2/11 2nd surgery - rod in Left femur
2/11 tx eribulen -- suspended dx brain mets
3/11 brain mets wbr 20 tx
4/11 halaven; discontine 8/11 not working
8/11 radiation to left femur 20 tx'
8-9/11 rad to lower spine
9/11 abraxane/herceptin/zometa
9/12 xeloda/herceptin/zometa
12/12 ablation of liver
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07-17-2010, 08:37 AM
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#9
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Senior Member
Join Date: Jan 2010
Posts: 170
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Re: Anyone applied/enrolled in TDM1 EAP?
Jessica- What fabulous news! I know how relieved you are. Everyone has given you the best advice. Rest, eat well, and do try to take short walks. My dog and I go for a 30-40 minute walk in the early morning before it gets hot, and it is really my favortite part of the day. I do believe it has helped me to stay positive and strong through this journey.
Take care of yourself and CONGRATULATIONS,
Emelie
__________________
Nov. 2006-IDC with Her2 +++
A/C for 3 rounds
Dec. 2006- Herceptin and Taxotere
March 2007-MRM with 8 of 14 lymph node involvement
May 2007-36 Rads
Sept. 2007- Stopped Herceptin
Jan. 2010- CT scan shows enlarged lymph nodes in sternum and lung involvement
Feb. 2010-PET scan shows mets to liver, lung, lymph nodes and bone
Feb. 2010- Started Herceptin/Taxol and Zometa
April 2010-PET scan clear. Herceptin and Zometa
June 2010- Stopped Herceptin continue Zometa and still NED
August 2010-Back on Herceptin and Zometa every 3 weeks
August 13, 2010- Had another port placed
August 24, 2010- PET scan clear. Herceptin and Zometa every three weeks
Nov. 2010-PET scan clear
Feb. 2011-Brain MRI clear
March 2011- PET scan clear
May 2011- PET scan clear
Sept. 2011- PET, Mammo, Bone Scan all clear- Herceptin only
March 2012-Recurrence in lungs and tumor around pota hepatis artery. Added Navelbine to herceptin
April 2012- Entered palliative care
June 5, 2012-Entered hospice care
Planning my memorial
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07-22-2010, 03:56 PM
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#10
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Senior Member
Join Date: Feb 2008
Location: Georgia
Posts: 1,486
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Re: Anyone applied/enrolled in TDM1 EAP?
Jessica,
Glad to hear your good news. Lets us know what happens about the trial.
Amelia
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07-22-2010, 04:23 PM
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#11
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Senior Member
Join Date: Oct 2006
Location: Louisville KY
Naples FL
Posts: 665
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Re: Anyone applied/enrolled in TDM1 EAP?
Jessica Great news and you have a plan which makes
us feel better. Best of luck and keep us posted.
I am from Nashville and its a nice city to be in.
patb
__________________
patb
Diagnosed June, 06, Stage I, Grade3, ER+PR- Her2positive, No Nodes. A/C X 4. Radiation 33 with boost, Herceptin every two weeks until Nov.
07, Arimedex for 5 years. Mugas and Echo and chest xRay. Bone scan of whole Body, and Back of Brain and spine MRI.
CT scan of Lungs every six months
due to two small places. December
2009, bone scan due to bone pain.
Follow up test in 2010.
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07-23-2010, 05:34 AM
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#12
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Senior Member
Join Date: Jan 2008
Location: Evergreen, Colorado
Posts: 454
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Re: Anyone applied/enrolled in TDM1 EAP?
Jessica,
How did I miss your post?? That is GREAT news!!! Whew!!! Counting down the days to August 3rd.
Taking care of your body and spirit is exactly the ticket.
How generous of Vicky to offer to help out...take her up on the offer!!! Sounds like a new friendship. Isn't it wonderful how god places what we need in our path, when we need it???
Jessica...you are such an inspiration, please keep us posted.
Thinking of you....Lori
__________________
2007
Oct - Diagnosed - Stage IV 5 c.m. IDC - Left Side er/pr- Her2+++ Node + 2/14 - Single Liver Met Double Mastectomy Nov - Begin T+H 2008
Feb-Complete 6 cycles- T&H- NED
March - Continue - Herceptin Only
April - Rads for 6 weeks
2009
Continue Herceptin - Continue NED
April - Recurrance- 3 cm. Liver Met
May - Cryosurgery
June - November - Abraxane + Herceptin
Aug - PET/CT - CTC = 0 Back to NED
2010
January - Continue NED
July - Recurrance - 3 cm Liver Met CTC=1
August - Cryosurgery #2
August - November Navelbine
November - Back to NED - End Navelbine
2011
Feb - Recur - 4 cm Liver Met - Same Left Lobe
March Surgery it is -Couldn't get a clean margin
July - Confirmed continued liver involvement
August - Begin Herceptin + Tykerb
October - Mixed results from H+T
Add Abraxane + H + T - Nov - April
2012
January PET Scan - It's working!!
April - Back to NED
July - Recurrance
August - Begin TDM-1 Trial (Taxol + TDM-1)
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07-23-2010, 10:46 AM
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#13
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Senior Member
Join Date: Aug 2008
Location: San Francisco
Posts: 260
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Re: Anyone applied/enrolled in TDM1 EAP?
Hi Jessica - Just wanted to add my voice to your cheering section. Fabulous news about your scans and getting access to T-DM1. Keep us posted on your status. We are all pulling for you and praying that this drug will be the miracle we all hope and need it to be.
__________________
4/17/08: Dx Stage IV at age 30 - extensive mets to liver, lungs, and bones. Er/Pr-, Her2+++
April 08-Aug 08:Taxotere, Cytoxan, Herceptin, Zometa - complete response!
Sept 08-Dec 08: Herceptin +Zometa for maintenance.
Jan 09-April 09: Brain mets. Add Tykerb. Watch and wait.
April 09: Gamma Knife 10 brain mets, add Xeloda.
Sept 09: Gamma Knife to 1 brain met.
Nov 09- April 10: Lung progression, add Gemzar to Herceptin, Zometa.
May 10- Sept 10: HER2 Vaccine Trial
Sept 10: Add Tykerb for more brain mets.
Oct 10: Gamma Knife to 7 brain mets.
Dec 10: Switch from Zometa to Denosumab.
Jan 11: Gamma Knife to 3 brain mets.
March 11: Gemzar/Herceptin for lung/bone progression.
April 11: More brain mets - Intrathecal Herceptin
June 11: Ixempra/Herceptin for lung, soft tissue progression.
Aug 11: Gamma Knife
Sep 11: Abraxane/Herceptin
Future: NED
Send me a PM if you'd like to follow my journey on Caringbridge.
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07-23-2010, 02:09 PM
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#14
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Senior Member
Join Date: Dec 2006
Posts: 415
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UpdateRe: Anyone applied/enrolled in TDM1 EAP?
Thank you everyone for your cheers & encouragement.
After the disappointment of not qualifying for the last TDM1 trial in Indianna, I've been holding my breath as I've waited to hear back from the folks in Nashville.
The good news is I just spoke w/the research nurse and she's reviewed my records and based on that information, I should qualify for the study.
I have an appoinment to consult with the research doc & screen for the study on August 3rd. Once I've signed the consent form, they'll order another echo and a CT to get accurate measurements of the mets. God-willing, I will be able to start drug on August 10th.
I'm still feeling cautious however. Hoping an praying that the results of the echo and CT don't hold any surprises that would prevent me from getting into the study.
We'll also be watching my cbc's closely in the next two weeks, to make sure my counts don't drop so low that I would need another transfusion, because that could cause a problem too.
So, everyday I'm feeling better and stronger now that I've been off Ixempra for over 2 weeks and that's encouraging. The challenge is trying to stay relaxed and positive for another 2 weeks as I wait to screen for the study.
Vicky-thank you for your sweet and generous offer. Hopefully we'll have a chance to meet, as I hope to be coming to Nashville every 3 weeks for the TDM1. It sounds like you're doing well, and I'm so happy for you!
Thanks everyone again for the support. You have all made this journey a little less bumpy with your kindness~
Keep the Faith~
Jessica
Last edited by jml; 07-23-2010 at 02:11 PM..
Reason: typos
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07-24-2010, 05:31 AM
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#15
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Senior Member
Join Date: Sep 2005
Location: MN
Posts: 731
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Re: Anyone applied/enrolled in TDM1 EAP?
Glad to hear things are coming together for the t-dm1 and am holding good thoughts that it will all be a GO! Waiting is hell and 2 weeks seems like forever I'm sure so I hope you can plan some nice 'distractions' for yourself during this time doing exactly what you like to do. So glad you hear you are feeling a little better too. Amazing how the body can bounce back so nicely with a chemo break.
__________________
Pam
6/01 IBC er+ her2+stage IIIb; mastecomy
7/01 AC, taxol; radiation
2/02 tamoxifen
9/02 stage IV bone mets femara
1/03 taxotere/herceptin/aredia
6/03 herceptin, aredia & faslodex
1/04 navelbine, herceptin, aredia
2/05 herceptin/aredia
7/05 xeloda/herceptin/aredia
3/07 xeloda/tykerb/aredia
5/08 taxol/avastin/aredia
2/09 gemzar/herceptin/zometa
7/09 Taxol/Carbo/Herceptin, zometa
10/09 navelbine/herceptin & zometa
2/10 herceptin & tykerb & zometa
4/10 add xeloda &aromasin
10/10 dx with dermatomyiositis triggered by cancer
11/10 restart herceptin, tykerb, zometa
12/10 surgery-place rod in R femur to stabilize bone
1/11 radiation to R femur - 20 tx
2/11 2nd surgery - rod in Left femur
2/11 tx eribulen -- suspended dx brain mets
3/11 brain mets wbr 20 tx
4/11 halaven; discontine 8/11 not working
8/11 radiation to left femur 20 tx'
8-9/11 rad to lower spine
9/11 abraxane/herceptin/zometa
9/12 xeloda/herceptin/zometa
12/12 ablation of liver
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