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02-10-2012, 07:21 PM
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#1
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Senior Member
Join Date: Jan 2007
Location: UK
Posts: 617
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For those of you on the extended TDM1
Is it still considered as a "trial" i.e. do they provide the drug free of charge & do they collect the data??
Just curious
__________________
35 y/o
June 06: BC stage I
Grade 3; ER/PR neg
Her-2+++; lumpectomies
Aug 06: Stage IV
liver mets: 6 tumours
July 06 to Jan 07: 2*FEC+6*Taxotere; 3*TACE; LITT
March 07- Sept 07: Vaccination trial (phase 2, peptide based) at the UW (Seattle).
Herceptin since 2006
NED til Oct 09
Recurrence Oct 2009: to internal mammary gland since October 2009 missed on Oct and March 2010 scan.. palpable nodes in May 2010 when I realised..
Nov 2011:7 mets to lungs progressing fast failed hercp/tykerb/xeloda combo..
superior vena cava blocked: stent but face remains puffy
April 2012: Teresa Trial, randomised to TDM1
Nov 2012 progressing on TDM1
Dec 2012 blockage of my airways by tumours, obliteration of these blocking tumours breathing better but hoping for more- at mo too many tumours to count in the lungs and nodes.
Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor.
'Under no circumstances should you lose hope..' Dalai Lama
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02-11-2012, 10:25 AM
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#2
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Senior Member
Join Date: Aug 2006
Posts: 79
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Re: For those of you on the extended TDM1
yes it is still a trial--the drug remains free. The drug co. dictates the rules.
Kathy T
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02-11-2012, 10:37 AM
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#3
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: For those of you on the extended TDM1
I ran into my study buddy last week at the lab...she is still on the extension study, now at 4 years on tdm1!!!!
__________________
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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02-19-2012, 08:00 AM
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#4
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Senior Member
Join Date: Jan 2007
Location: UK
Posts: 617
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Re: For those of you on the extended TDM1
working for 4 years..music to my hear.. it is interesting to know I just wonder why they are not so keen to have EAP and why it represent such a risk investment if it is like a trial..
__________________
35 y/o
June 06: BC stage I
Grade 3; ER/PR neg
Her-2+++; lumpectomies
Aug 06: Stage IV
liver mets: 6 tumours
July 06 to Jan 07: 2*FEC+6*Taxotere; 3*TACE; LITT
March 07- Sept 07: Vaccination trial (phase 2, peptide based) at the UW (Seattle).
Herceptin since 2006
NED til Oct 09
Recurrence Oct 2009: to internal mammary gland since October 2009 missed on Oct and March 2010 scan.. palpable nodes in May 2010 when I realised..
Nov 2011:7 mets to lungs progressing fast failed hercp/tykerb/xeloda combo..
superior vena cava blocked: stent but face remains puffy
April 2012: Teresa Trial, randomised to TDM1
Nov 2012 progressing on TDM1
Dec 2012 blockage of my airways by tumours, obliteration of these blocking tumours breathing better but hoping for more- at mo too many tumours to count in the lungs and nodes.
Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor.
'Under no circumstances should you lose hope..' Dalai Lama
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02-19-2012, 10:53 AM
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#5
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: For those of you on the extended TDM1
Roche's number one priority is to get this drug approved. The barriers dropped in front of this process have been incredible - unconscionable some might say. The decision to close the EAP was a difficult and painful one (certainly for patients!) but was made in the interest of getting access for everyone via FDA approval.
That approach has manifested itself in the design of trials with 2/3 randomization to TDM1, and the opening of multiple large phase 3 trials.
One of the most perverse consequences of the FDA requirement to provide overall survival data is that it basically precludes anyone who has been in a TDM1 trial in a control arm from being allowed to get it later, say in an EAP. If everyone in a control arm (no TDM1) and had progression then subsequently got TDM1 and it worked, they would never be able to show a survival benefit and thus gain approval.
One very cool thing is the pertuzumab/TDM1 trials. In those, you may or may not get pertuzumab, but you definitely get TDM1, so a very likely winner in either case!
__________________
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
Last edited by chrisy; 02-19-2012 at 10:56 AM..
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02-21-2012, 08:26 AM
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#6
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Senior Member
Join Date: Jan 2007
Location: UK
Posts: 617
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Re: For those of you on the extended TDM1
Chrisy, thank you very much for the clear explanations. Indeed a perverse demand by FDA and I do wonder why this could not simply be done on referential data prior to TDM1, there must be a lot of data available for how long someone lives once metastatic, progressive and with Her2.
I cannot see that trial anywhere tdm1+/-pertuzumab but indeed it sounds good Is this in the pipeline?
__________________
35 y/o
June 06: BC stage I
Grade 3; ER/PR neg
Her-2+++; lumpectomies
Aug 06: Stage IV
liver mets: 6 tumours
July 06 to Jan 07: 2*FEC+6*Taxotere; 3*TACE; LITT
March 07- Sept 07: Vaccination trial (phase 2, peptide based) at the UW (Seattle).
Herceptin since 2006
NED til Oct 09
Recurrence Oct 2009: to internal mammary gland since October 2009 missed on Oct and March 2010 scan.. palpable nodes in May 2010 when I realised..
Nov 2011:7 mets to lungs progressing fast failed hercp/tykerb/xeloda combo..
superior vena cava blocked: stent but face remains puffy
April 2012: Teresa Trial, randomised to TDM1
Nov 2012 progressing on TDM1
Dec 2012 blockage of my airways by tumours, obliteration of these blocking tumours breathing better but hoping for more- at mo too many tumours to count in the lungs and nodes.
Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor.
'Under no circumstances should you lose hope..' Dalai Lama
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03-05-2012, 07:10 PM
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#7
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: For those of you on the extended TDM1
Lorraine is now on the t dm-1 extension. Gen. pays for drug. Its a " trial ' , but since This FDA refuses to let gen. use the expanded access or extension data ( like Lorraine doing well 16 months since being at deaths door step), the data wont count. As others have said This FDA's obstruction of accelerated approval , thier slowing down , pushing for lengthier overall survival stats is criminal. Killing pts. Will be investigated. It will be the Legacy of Pres. Obama : Losing The War on Breast Cancer, Putting A Cost on a Human Life ( Avastin, T DM-1 ? )... while spending trillions on wars...
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05-10-2012, 04:40 AM
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#8
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: For those of you on the extended TDM1
The pert/ tdm-1 / taxol trial is at Sloan in NY, Farber in Boston. everyone gets t dm-1, low dose , which helps avoid platelet issues. taxol gets dropped after 3mos if you respond. The pert is 50/50 randomized , but we see great results w/ just initial taxol , and low dose , weekly t dm-1. W/o pert. pert sounds good, but its not achemo. t dm-1 is already proven. its " the bomb", literally, for strong her2. The rumor mill says that pert's approval may be conditional, for early stage ? That would be CRAZY on This FDA's part. I've already written them . I think "Dr. " Pazdur and his t dm-1 " advisors " should be removed, they are completely un-able to make rational decisions about these 2 drugs.
On another note, someone form the UK , says T DM-1 should be approved soon, a few months ?, quicker than here. What else is new ? Now, that's a Good Rumor !
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05-11-2012, 04:41 PM
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#9
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Senior Member
Join Date: Oct 2008
Posts: 88
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Re: For those of you on the extended TDM1
Phil /
Not receiving access to Pertuzamaub
For stage IV is criminal. What do we need
to do - die in someones office? It's getting
to that point!
Kim
__________________
------------------------------
Dx Stage 3C 2005, triple +, tons of lymph nodes as well. FEC, surgery, TCH, rads, herceptin 1 year. And, Aromasin.
2007 - recurrence to medistinal lymph node, Abraxene and Herceptin - took it down 50%
2008 - on Arimidex/Herceptin - stable lymph node.
2009 - stable on Arimidex/Herceptin
2010 - lymph node progression and liver mets.
2010 - went on Gemzar, Navelbine, Herceptin - Navelbine and Herceptin took liver mets down. lymph node slightly progressed.
2010 - did Xeloda & Tykerb - MAJOR progression in liver in only 6 weeks.
Dec 2010 - present - Ixempra/Avastin/Herceptin/Fasoldex - regressing
June 2012 - chemo break
Sept 19, 2012 - start t-dm1. Chose this over going back on Ixempra.
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05-12-2012, 11:31 AM
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#10
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Senior Member
Join Date: Oct 2008
Posts: 88
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Re: For those of you on the extended TDM1
http://www.roche.com/media/media_rel...2012-02-08.htm
The above article for priority review on
Pertuzamaub states for 1st line and those
that have failed adjuvant therapy. I believe
the failure clause allows access to
Mets pts.
Kim
__________________
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Dx Stage 3C 2005, triple +, tons of lymph nodes as well. FEC, surgery, TCH, rads, herceptin 1 year. And, Aromasin.
2007 - recurrence to medistinal lymph node, Abraxene and Herceptin - took it down 50%
2008 - on Arimidex/Herceptin - stable lymph node.
2009 - stable on Arimidex/Herceptin
2010 - lymph node progression and liver mets.
2010 - went on Gemzar, Navelbine, Herceptin - Navelbine and Herceptin took liver mets down. lymph node slightly progressed.
2010 - did Xeloda & Tykerb - MAJOR progression in liver in only 6 weeks.
Dec 2010 - present - Ixempra/Avastin/Herceptin/Fasoldex - regressing
June 2012 - chemo break
Sept 19, 2012 - start t-dm1. Chose this over going back on Ixempra.
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09-07-2012, 08:50 AM
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#11
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Senior Member
Join Date: Jul 2008
Posts: 186
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Re: For those of you on the extended TDM1
Stockton, Cal and Plantation, Fla centers now partaking in T-DM1's expanded access program.
http://clinicaltrials.gov/show/NCT01120561 |
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09-07-2012, 11:37 AM
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#12
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Senior Member
Join Date: Oct 2008
Posts: 88
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Re: For those of you on the extended TDM1
Schoonder -
Bless You! I just found out I progressed
yesterday. When I saw your posting, I
could not believe my eyes!!!
I called Stockton - they believe I qualify and
I have appt next week with them!
Hugs,
Kim
__________________
------------------------------
Dx Stage 3C 2005, triple +, tons of lymph nodes as well. FEC, surgery, TCH, rads, herceptin 1 year. And, Aromasin.
2007 - recurrence to medistinal lymph node, Abraxene and Herceptin - took it down 50%
2008 - on Arimidex/Herceptin - stable lymph node.
2009 - stable on Arimidex/Herceptin
2010 - lymph node progression and liver mets.
2010 - went on Gemzar, Navelbine, Herceptin - Navelbine and Herceptin took liver mets down. lymph node slightly progressed.
2010 - did Xeloda & Tykerb - MAJOR progression in liver in only 6 weeks.
Dec 2010 - present - Ixempra/Avastin/Herceptin/Fasoldex - regressing
June 2012 - chemo break
Sept 19, 2012 - start t-dm1. Chose this over going back on Ixempra.
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09-07-2012, 12:47 PM
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#13
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Senior Member
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
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Re: For those of you on the extended TDM1
Kim,
What a wonderful blessing to find that post! I hope you qualify and it is very effective for you.
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes
Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"
Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla
Reconstruction: TRAM flap, partial loss, Revision
The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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09-07-2012, 01:13 PM
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#14
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Senior Member
Join Date: Aug 2009
Location: Moultrie, GA
Posts: 431
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Re: For those of you on the extended TDM1
This site is wonderful! I just met another HER2 sister and I told her about the wealth of information one can learn from the very intelligent and informed members. You ALL are great!!
__________________
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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09-07-2012, 06:23 PM
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#15
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Senior Member
Join Date: Nov 2010
Posts: 393
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Re: For those of you on the extended TDM1
Chrisy , I wish your study friend with 4 yrs would join our activist group. next time you see her ask if she would contact me ! Lorraines ct this week : NED !! 10 months NED, 22 months of stability overall !!
went to Pres Obamas Rally today. they wouldny let us in , becuase we had FDA ! Approve T DM-1 Now shirts on. asked if we were for the Pres. we said our organization is neither for or against, we are for reforming This FDA. they nicely said , sorry, only the Pres's message gets out today. we had agood time giving out t dm-s1 flyers, info on FDA politics , getting our pic taken. one woman filmed us for a" documentary ". we'll see. you stage iv 'er s who can , got to demonstrate, its exhilirating ! check out the Globe video on http://stageivsurvivor.webs.com |
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09-08-2012, 03:33 PM
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#16
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Re: For those of you on the extended TDM1
Phil, great news on Lorraine's scans! I don't see my study buddy often, it was a chance meeting. I don't even know her last name or if she is still on study. Shame on me!
But if I do see her, I will ask her to contact you.
__________________
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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09-08-2012, 04:42 PM
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#17
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Senior Member
Join Date: May 2012
Location: Bethlehem PA
Posts: 395
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Re: For those of you on the extended TDM1
Great video Phil, good for you...good for all my stage IV sisters. I signed the petition and passed it on....
__________________
 39 year old wife, mother of one and nurse.
April 20, 2012: Dx Invasive Ductal Carcinoma
April 25, 2012: ER+(5%), PR-, HER2+++
May 10, 2012: BRCA 1,2 Negative
May 23, 2012: MUGA Scan EF 70%
May 31, 2012: B/L Mastectomy. 2/2 nodes removed and CLEAR!! Power Port placed. 2 Drains. 2 Expanders placed
June 5, 2012: Drains OUT! Ahhhh..
June 12, 2012: Final Pathology Report, .8x.3cm tumor. Micromets to 1 node .35mm under cytokeratin staining. Stage 2A. Onc says "you are lucky to have found this early"
July 10, 2012: Started 6 rounds of TCH with weekly H
Sept 5, 2012: MUGA 65%
Sept 20, 2012: CAT scan of brain clear!
Oct 23, 2012: LAST TC! AMEN! Continue Herceptin every three weeks until July 2013.
Nov 19, 2012: Port out!
Dec 5, 2012: Started radiation
Dec. 10, 2012: MUGA 65%
Dec. 13, 2012: Turned 40. BEST BIRTHDAY EVER!
Jan 23, 2013: Last radiation. Told I am NED. Continue Herceptin every three weeks till July 2013.
Jan 29, 2013: Begin 5 years of Tamoxifen.
Feb 28, 2013: CT Scan with Contrast of lungs. 5mm and 4mm nodules of unknown origin. Rescan in 3 months.
Mar 6, 2013: EF 60%
May 8, 2013: Exanders out, implants implanted...abd. lipo and fat moved up. Girls are looking good!
June 3, 2013: CT Scan with Contrast of lungs. Previous nodules gone. New nodules (2mm and 3mm) found. Rescan in 3 months. So sorry I opened this can of worms...
June 11, 2013: EF 60%
June 25, 2013: Last Herceptin. wow...
Aug 20, 2013: Tumor markers within normal limits. Xray to sore left ribs shows no disease or fractures.
Sept 9, 2013: CT of lungs shows no disease. Closing this can of worms and moving on.
Nov 20, 2013: Tumor markers within normal limits. Severe Vit D deficiency, started on prescription Vit. D. Blaming chemo for this.
Feb 2014: Tumor markers within normal limits.
May 2014: Tumor markers within normal limits. Graduated to twice yearly onc appts.
Oct 2014: Tumor markers within normal limits.
May 2015: Tumor markers WNL. Bone density scan fine. Bone scan and xray of ribs shows "something" 4th right rib. Could be healed fracture but if it is healed why does it hurt?
Nov 2015: Tumor markers WNL. Follow up bone scan clear.
Feb 2016: Syncope! WTF? Dizzy too. Brain scan clear, ECHO EF 60%, Halter Monitor shows heart is fine. Viral? I will never know.
June 2016: Tumor markers WNL.
Oct 2016: Stabbing pain right eye. Long story short, trigeminal neuralgia.
Nov 2016 Brain MRI clear.
Jan 2017: Tumor markers WNL, still getting weird pain right rib area, and sometimes right upper chest. Xray x2, Bone Scan, Breast MRI all clear. Scar tissue? Rads. I may never know.
www.onmywaytosurvivorhood.blogspot.com
www.thechemobag.com
www.facebook.com/thechemobag
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