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03-02-2008, 07:05 PM
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#1
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Senior Member
Join Date: Sep 2005
Posts: 589
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Nervous about trial exclusions
Hi all,
After 3 weeks of low dose Adriamyacin, Caryn's markers have shot up and she is off to Sloan on Tuesday to discuss a new trial. While I do believe there are good trials out there like herceptin dmm1 I am very concerned that Caryn will be excluded from most due to previous treatment. Seems like the only available trials at Sloan will be phase 1. With the success rate of phase 1 trials being very low I want better odds for her! I know how important these trials are and I feel badly but I just don't want to risk losing the center of my kids universe and the best thing that's ever happened to me. I understand it but hate that the numbers are more important than the valuable lives that the drugs may save.
Thanks for listening!
Eric
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03-02-2008, 07:28 PM
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#2
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Senior Member
Join Date: Nov 2007
Location: Connecticut
Posts: 2,077
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Eric, I know you guys are going through a tremendously difficult time. You're dealing with something nobody should have to deal with, as a good friend said to me. Try to hang in there until Tuesday. I'll be praying for you and Caryn that new alternatives and trials will be presented to you then. You guys are in my thoughts and prayers.
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03-02-2008, 07:45 PM
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#3
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Senior Member
Join Date: Sep 2005
Posts: 589
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Thanks Bill.
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03-02-2008, 07:47 PM
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#4
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Senior Member
Join Date: Jan 2008
Posts: 305
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I too will remember you in my prayers.
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03-02-2008, 07:59 PM
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#5
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Senior Member
Join Date: Jul 2007
Location: Northern California
Posts: 764
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Eric,
I just wanted to add my prayers. Please know that I will be thinking of you and your family on Tuesday.
__________________
DX 02/01/07
2.5 cm, Er/Pr-, Her2+++
18/20 Nodes
03/07 CT & Bone scan - Clear
AC x 4, Taxol x 4, Added Herceptin
Radiation until 09/07
Herceptin every 3 weeks until 06/08
01/10/08 local recurrence -IBC
01/28/08 CT & Brain MRI - clear
02/08 - Navelbine & Herceptin
05/08 -MRM
05/08 - Gemzar & Herceptin - didn't work
09/08 - Hyperthermia rads
03/09 - Tykerb/Xeloda
05/10 - Tram flap to fix wound
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03-02-2008, 08:05 PM
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#6
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Senior Member
Join Date: Aug 2001
Location: Oregon
Posts: 1,756
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Eric, I share your frustration at the exclusion criteria for Phase III trials. I don't know the answer either, but I'll be thinking of you both on Tuesday...keep us posted.
<3 Lolly
__________________
Sept.'99 - Dx.Stage IIIB, IDC ER/PR-, HER2+++ by IHC, confirmed '04 by FISH. Left MRM, AC x's 4, Taxol x's 4, 33 Rads, finishing Tx May 2000. Jan.'01 - local/regional recurrence, Stage IV. Herceptin/Navelbine weekly till NED August 2001, then maintenance Herceptin. Right Mast. April 2002. Local/Regional recurrence April '04, Herceptin plus/minus chemo until May '07. Gemzar added from Feb.'07-April '07; Tykerb/Abraxane until August '07, back on Herceptin plus Taxotere and Xeloda Sept. '07. Stopped T/X Nov. '07, stopped Herceptin Dec. '07, started Avastin/Taxol/Carboplatin Dec. '07. Progression in chest skin, stopped TAC March '03, started radiation.
Herceptin has served as the "Backbone" of my treatment strategy for over 6 years, giving me great quality of life. In 2005, I was privileged to participate in the University of Washington/Seattle HER2 Vaccine Trial.
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03-02-2008, 08:28 PM
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#7
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Senior Member
Join Date: Mar 2007
Location: CHARLOTTE NC USA
Home town (ECUADOR) South America
Posts: 542
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.....always the waiting time ....!!!but, hang in there ....I will do the same thing with my test's tomorrow .....Caryn and you will be in my prayers ...
__________________
Lily Diag April/06 5 months after give birth my son Max stage IV mets on liver (5 tumors) 38 year old, her2+++ and ER+PR+ from32 nodes 4 positives mastectomy right breast chemo before surgery herceptin/carboplatin/taxotere ,clear and surgery have radiation 20, `& then herceptin and tamoxifen NED until Aug/07 body only then 'n June 04-06-07 .1 lesion of 1.6 cm on cerebellum ...novalis ,open sugery 5m.m brain met again novalis, 4mm.In the liver. Waiting 2 months now 3 tumors enroll on T-MCC trial start first infusion Nov 5/07 at Dec 17 scan show one tumor despair the 2nd and 3th diminish Doc said great results until March/08 ct scan show progression 03-05-08 start tykerb & xeloda
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03-02-2008, 09:06 PM
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#8
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Senior Member
Join Date: Aug 2006
Location: Sheboygan, WI
Posts: 2,582
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Hi Eric,
Thank you for sharing your feelings with us here. The "fear" you feel is "heard" here and my heart goes out to you. I want to say that I am sorry you two are having to go through this. I truly am. My prayer for good news for you on Tuesday are being said as I type this. I also ask our Lord to give you His strength and Peace as you wait.
Love to you..................from my heart....
Mary Jo
__________________
"Be still and know that I am God." Psalm 46:10
Dx. 6/24/05 age 45 Right Breast IDC ER/PR. Neg., - Her2+++ RB Mast. - 7/28/05 - 4 cm. tumor Margins clear - 1 microscopic cell 1 sent. node No Vasucular Invasion 4 DD A/C - 4 DD Taxol & Herceptin 1 full year of Herceptin received every 3 weeks 28 rads prophylactic Mast. 3/2/06
17 Years NED
<>< Romans 8:28
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03-03-2008, 12:24 AM
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#9
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Senior Member
Join Date: Feb 2006
Location: Acworth, GA
Posts: 2,104
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Eric,
I will keep you and Caryn in my prayers for Tuesday and every day. I know how difficult it is for you both.
__________________
Kate
Stage IIIC Diagnosed Oct 25, 2005 (age 58)
ER/PR-, HER2+++, grade 3, Ploidy/DNA index: Aneuploid/1.61, S-phase: 24.2%
Neoadjunct chemo: 4 A/C; 4 Taxatore
Bilateral mastectomy June 8, 2006
14 of 26 nodes positive
Herceptin June 22, 2006 - April 20, 2007
Radiation (X35) July 24-September 11, 2006
BRCA1/BRCA2 negative
Stage IV lung mets July 13, 2007 - TCH
Single brain met - August 6, 2007 -CyberKnife
Oct 2007 - clear brain MRI and lung mets shrinking.
March 2008 lung met progression, brain still clear - begin Tykerb/Xeloda/Ixempra
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03-03-2008, 06:25 AM
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#10
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Senior Member
Join Date: Sep 2005
Posts: 589
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Thank you all. I appreciate your prayers and thoughts. Lily, my prayers are with you for your test results as well. Please let us know how they come out.
Love to all,
Eric
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03-03-2008, 07:15 AM
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#11
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Senior Member
Join Date: Nov 2007
Posts: 210
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eric.. the phase one trial of trastuzumab-dm1 is the same as the phase 2 trial. except phase 1 is given each week vs.. every 3 weeks..
also the phase 1 has fewer limitations than the phase 2.. p2 excludes patients who have maxed out on adriamycin...although i hear they are moving to amend that limitation as we speak.. also the phase2 limits patients to a max of 3 prior regimens of chemotherapy.. which also may soon be amended..
do not be afraid of the class of trial ....phase 1 vs phase 2 or 3 etc....
genentech is already making plans for approval of this product.. i dont have the link available at the moment but genentech already has in place the ability to mass produce and distribute this product upon approval.. they also have the ability to make pivotal trial material TODAY...
the response rate for the tras-dm1 trial has being nothing short of phenomenal for the ladies on this trial ... reported at SABC in dec 2007.. 12 of 15 patients dosed every 3 week achieved stable or partial response.. which is a far greater response than herceptin alone.. genentech likely already has enrolled /treated close to 50 patients in the phase 2 portion of this trial...
the initial phase 1 trial is close to full enrollment at the only 4 sites available..
talk to caryns doctors... the phase 1 or p2.. if she can get into it.. has worked very well for the 5 ladies on this forum who are currently being treated.
good luck and god bless
run to live..
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03-03-2008, 06:45 PM
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#12
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Senior Member
Join Date: Sep 2005
Posts: 589
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That's great info Runtolive. I will discuss tomorrow and keep in mind at other locations based on Sloans recommendation. I hope to have a direction and update for everyone tomorrow. I do feel a bot better thanks to each of you. The info, support and love...it all helps. Thank you!!
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03-04-2008, 02:07 PM
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#14
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Senior Member
Join Date: Nov 2005
Location: Lincoln, Rhode Island
Posts: 371
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Dear Eric,
You and Caryn and in my thoughts and prayers each and everyday. Please le us know how you make out.
__________________
Love and Hope
Karen
IDC
DX 1998 STAGE I ER+/ PR+
AC CHEMO TILL FEB 1999
Tamxofin till 2001
2001 exstensive liver mets and mets to lungs
Started weekly taxol
Jan 2002 found out I was strongly HER2POS+++ started herceptin continued with taxol and herceptin till June 2002 then from June 2002 till Jan 2005 just herceptin and Arimidex
2005 Navelbine herceptin had RFA Then back on taxol with herceptin
April 2006 progression again went on clinical trial with tykrerb/herceptin progressed on the started Xeloda/ herceptin
Feb 2007 started Doxil
August 2007 Taxotere,Carboplatin and Herceptin exstensive mets to liver and pancreas
October 2007 Had to stop Carboplatin due to sever allergic reaction
Jan 2008
Stopped Taxotere due to progression now on Gemzar and Herceptin
March 2008 Starting Carboplatin, Abraxane, and Herceptin.
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06-25-2008, 10:24 AM
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#15
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Senior Member
Join Date: Nov 2007
Posts: 210
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how has caryn been doing in the trial. fewer side effects i hope..
run
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06-25-2008, 08:04 PM
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#16
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Senior Member
Join Date: Nov 2007
Location: Connecticut
Posts: 2,077
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That is good news, Eric, regarding the lowering of the dosage. You and Caryn stay strong. For what it's worth, you're in my thoughts and prayers, Bill
__________________
For Nicola
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06-25-2008, 08:07 PM
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#17
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Senior Member
Join Date: Mar 2007
Location: CHARLOTTE NC USA
Home town (ECUADOR) South America
Posts: 542
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Good News !!!
__________________
Lily Diag April/06 5 months after give birth my son Max stage IV mets on liver (5 tumors) 38 year old, her2+++ and ER+PR+ from32 nodes 4 positives mastectomy right breast chemo before surgery herceptin/carboplatin/taxotere ,clear and surgery have radiation 20, `& then herceptin and tamoxifen NED until Aug/07 body only then 'n June 04-06-07 .1 lesion of 1.6 cm on cerebellum ...novalis ,open sugery 5m.m brain met again novalis, 4mm.In the liver. Waiting 2 months now 3 tumors enroll on T-MCC trial start first infusion Nov 5/07 at Dec 17 scan show one tumor despair the 2nd and 3th diminish Doc said great results until March/08 ct scan show progression 03-05-08 start tykerb & xeloda
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06-25-2008, 08:14 PM
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#18
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Senior Member
Join Date: Oct 2007
Posts: 1,851
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Eric,
This is wonderful news about Caryn's response to the trial drug.
This trial was recommended to me on Monday by an oncologist at Sloan in lieu of surgery to remove a solitary lung met. But I'm not sure whether it's still open and plan to call the study doctor tomorrow. If it's open I'm thinking about participating in it.
Best, Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2023 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
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06-26-2008, 10:30 AM
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#19
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Senior Member
Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
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Eric, that's great news - hopefully giving Caryn enough of a break to recover more from the side effects while still being able to keep T DM1 in her arsenal.
I know Caryn is in a different trial than I am, but my trial coordinator (who is unnervingly overwhelmed by the protocols!) showed me the protocol book and while browsing I found the clause about allowing for the possibility of continued treatment based on "continued clinical benefit" even with side effects - the doctor in conjunction with the Genentech medical monitor do have some wiggle room!
__________________
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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06-26-2008, 09:19 PM
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#20
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Senior Member
Join Date: Jan 2007
Location: Thornhill, Ontario
Canada
Posts: 2,320
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Great news Eric.
Give my best to Caryn, from another Caryn.
all the best
caya (real name and spelling is Caryn)
__________________
ER90%+/PR 50%+/HER 2+
1.7 cm and 1.0 cm.
Stage 1, grade 2, Node Negative (16 nodes tested)
MRM Dec.18/06
3 x FEC, 3 x Taxotere
Herceptin - every 3 weeks for a year, finished May 8/08
Tamoxifen - 2 1/2 years
Femara - Jan. 1, 2010 - July 18, 2012
BRCA1/BRCA2 Negative
Dignosed 10/16/06, age 48 , premenopausal
Mild lymphedema diagnosed June 2009 - breast surgeon and lymph. therapist think it's completely reversible - hope so.
Reclast infusion January 2012
Oopherectomy October 2013
15 Years NED!!
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