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Topic: TDM1 (clinical trial study)

Forum: Stage IV and Metastatic Breast Cancer ONLY — A place for those managing the ups & downs of a Stage IV/metastatic breast cancer diagnosis. Please respect that this forum is for Stage IV members only or those posting on behalf of a Stage IV patient. There is a separate forum for Stage IV Caregivers/Family in "Support and Community Connections".

Posted on: Feb 13, 2011 10:18AM

OHdaughter7 wrote:

Hello, My mom is a stage IV HER2+  breast cancer patient. She is on her 4th year of fighting and has tried numerous different chemo/ radiation treatments. her doctor rec. she tried this TDM1 which is still in clinical trial we find out Wed if she qualifies. We have to Fly to MICH. becuase it is not offered here in ohio. Any information would be greatly appreciated.

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Feb 13, 2011 12:36PM Ready2Win wrote:

I have been on TDM1 since Nov. 2010.  It is working really well. The tumors in my liver have shrunk by 50%. I have scans again this week.  I get it every 3 weeks.  The side effects are not bad at all.  You do not lose your hair.  I am alittle tired pretty much all the time but I can still work and take care of my kids age 5 & 7.  Other than that the side effect are minimal. Constipation for a day or two, dry mouth for a day, thats about it.  I have to get blood work every week to watch my liver numbers and I get a PET every 6 weeks.  (alittle too often if you ask me)  They also monitor your heart with MUGAs.

 Where are you in Ohio?  I am in PIttsburgh and I participate in the trial at Magee UPMC.Maybe that is closer for your mom.

Good Luck.  PM me if you have any other questions

Dx 12/20/2008, IDC, 1cm, Stage IV, 0/0 nodes, mets, ER+/PR+, HER2+
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Feb 13, 2011 01:17PM EnglishMajor wrote:

http://her2support.org/vbulletin/

Might check here, too

Dx 7/6/2009, IDC, 3cm, Stage IV, Grade 3, mets, ER+/PR+, HER2-
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Feb 14, 2011 06:21AM mthomp2020 wrote:

How far north in Ohio are you?  I know there's an arm of the trial comparing Tykerb/Xeloda to TDM-1 in Hamilton, Ohio, which is just north of Cincinnati.

Marsha

Dx 5/21/2007, IDC, Stage IV, Grade 3, mets, ER-/PR-, HER2+
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Feb 14, 2011 10:43AM OHdaughter7 wrote:

hey we are in cleveland,ohio... its weird because the list that was given to us didn't have pitts or anything in ohio listed.. so we already made our appt in Detroit.. are you currently participating in the trial?

OHdaughter7

Dx 3/2005, Stage IV, mets, HER2+
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Mar 10, 2011 11:07AM chemogirl214 wrote:

Hi, I have been on TDM-1 since April 2010. Cancer free since July 2010. Feel fantastic.

I can only hope your mother does as well as I have on the trial.

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Mar 10, 2011 01:19PM Fitztwins wrote:

I was on the trial. Very easy drug to take. Going to Karmanos? I however had some progression (they think) so I was off. I think it is WONDERFUL. I can't wait until it is available to all.

Enjoy Every Sandwich.

Dx 12/12/2004, IDC, Stage IV, Grade 2, mets, ER+/PR+, HER2+Surgery 01/19/2005 Mastectomy (Left); Lymph Node Removal: Axillary Lymph Node Dissection (Left); Reconstruction: TRAM flap (Left)Chemotherapy 02/01/2005 Adriamycin, Cytoxan, TaxolRadiation Therapy 05/01/2005 ExternalTargeted Therapy 06/01/2005 HerceptinHormonal Therapy 01/01/2006 FemaraHormonal Therapy 06/02/2008 AromasinTargeted Therapy 07/01/2008 HerceptinTargeted Therapy 05/05/2010 TykerbHormonal Therapy 08/02/2012 TamoxifenHormonal Therapy 06/15/2013 Arimidex
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Mar 10, 2011 03:11PM ango74 wrote:

I was just dx'd with mets to my lungs and superclav last week.  I am considering this trial.  I had my first Nabelbine,Herceptin last friday.  For those of you that have been on it how long did it take you to actually get started on the trial. I am in Fort Worth TX and if I am correct there is a place San Antonio doing the trail.  I feel like I shiould do it but at the same time I am worried that it wont work and maybe I should do the current tx to hopefully shrink my tumors some.

Stage IV Dx mets 2/28/2011 to lungs er/pr- her2+

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Mar 10, 2011 04:04PM, edited Mar 10, 2011 04:06PM by EnglishMajor

Bostonians---there will be a story on 11 pm news tonight featuring Phil & Lorraine, detaling her TDM-1 experiences. (This will be more on access.) Will be on ABC, hopefully it will then be posted to www.bostonchannel.com

Dx 7/6/2009, IDC, 3cm, Stage IV, Grade 3, mets, ER+/PR+, HER2-
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Mar 10, 2011 05:39PM, edited Mar 10, 2011 06:57PM by Fitztwins

My doctor was really quick to get me on. If you can get on TDM1 I say GO FOR IT...It is the next phase of Herceptin. I had to go off my hormonals...If I could have been on these, I think I would still be on TDM1

Enjoy Every Sandwich.
Diagnosis: 12/12/2004, IDC, Stage IV, Grade 2, mets, ER+/PR+, HER2+

Enjoy Every Sandwich.

Dx 12/12/2004, IDC, Stage IV, Grade 2, mets, ER+/PR+, HER2+Surgery 01/19/2005 Mastectomy (Left); Lymph Node Removal: Axillary Lymph Node Dissection (Left); Reconstruction: TRAM flap (Left)Chemotherapy 02/01/2005 Adriamycin, Cytoxan, TaxolRadiation Therapy 05/01/2005 ExternalTargeted Therapy 06/01/2005 HerceptinHormonal Therapy 01/01/2006 FemaraHormonal Therapy 06/02/2008 AromasinTargeted Therapy 07/01/2008 HerceptinTargeted Therapy 05/05/2010 TykerbHormonal Therapy 08/02/2012 TamoxifenHormonal Therapy 06/15/2013 Arimidex
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Mar 10, 2011 08:07PM EnglishMajor wrote:

TheBostonChannel.com
Cancer Patient: Approval For New Drugs Takes Too Long
Patient Travels 950 Miles For Treatment Not Available in Boston

POSTED: 3:12 pm EST March 10, 2011
UPDATED: 10:03 pm EST March 10, 2011
BOSTON -- How long is too long to make cancer patients wait for promising new drugs? One local couple is frustrated with the Food and Drug Administration's approval process and is demanding changes.

Lorraine Heidke-McCartin and her husband, Phil, recently returned from their sixth trip to Virginia this winter. That's the closest place offering an experimental drug to control her advanced breast cancer, the couple said.

"I just had my first CAT scan done the week before last and everything has shrunk or it's gone already," Heidke-McCartin said.

In studies, T-DM1, a combination of Herceptin and chemotherapy, has shrunk tumors in 33 percent of women with advanced disease, according to Genentech, the drug maker. It also has few side effects.

But the travel, at her own expense, has taken a toll on the 54-year-old Hanson woman.

"It doesn't have to do with the treatment itself, but it has to do with what you're putting a stage IV, critically ill, terminally ill person through to get a drug," Heidke-McCartin said.

Last summer, doctors told Heidke-McCartin she was a perfect candidate for the drug and would start receiving it in Boston at Dana-Farber Cancer Institute in September.

"Then I picked up the paper, the FDA pulled the rug out, said Phil McCartin. "It's just baffling to me why the FDA did this."

The FDA denied accelerated approval and, according to a spokeswoman, will not comment publicly on the reason.

In a statement, drug maker Genetech said the FDA told them the drug did not meet the standard for accelerated approval "because all available treatment choices... had not been exhausted" among those in the study.

That infuriates Lorraine's husband.

"She and hundreds and hundreds of other women across the country have already exhausted all those other options," McCartin said.

Sen. John Kerry fired off a letter to the FDA, writing, "Especially when patients have exhausted existing treatment options, they shouldn't have to face unnecessary obstacles to innovative treatments that are potentially life-saving."

"As a general rule, it takes too long to get drugs to people who need them," said Dr. Eric Winer, director of the breast oncology center at Dana-Farber.

Winer said the overall drug approval process needs to be accelerated.

"One of those ways. potentially, is to issue preliminary approvals, do more definitive studies and recognize they may or may not get final approval," Winer said.

Genentech spokeswoman Krysta Pellegrino said, "We are really committed to this medicine."

She said potential FDA approval isn't likely until late 2012 or early 2013.

After several doses of T-DM1, Lorraine is looking better and feeling better.

"They're asking me how I'm doing, and I got very teary, and I said for the first time in I can't tell you how long, I feel like me." Heidke-McCartin said. "I was able to play on the ground with my grandchildren, run around with them. Do those kind of things that I've always dreamed I would be doing at this age."

Dx 7/6/2009, IDC, 3cm, Stage IV, Grade 3, mets, ER+/PR+, HER2-
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Mar 14, 2011 12:05PM MKOHIO wrote:

I've only had one treatment so far.  Had some heart rate issues and muscle pain issues, mostly in my hands and arms ?  Anyone have any side effects like this ?   Getting my hair back and getting back to work would be wonderful.  I hate that I have to go to Mich. to receive treatment when I have a wonderful doctor right here in Ohio.  My daughter, Ohiodaugter7 and my oldest daughter drive me.   My husband stays home and works and I really  miss that he is not with me.  This is my 4th go around with this beast in 4 yrs !  All I hear is great stuff about TDM1 ! 

MK

Dx 1/18/2011, 3cm, Stage IV, 3/3 nodes, HER2+
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Mar 14, 2011 03:13PM OHdaughter7 wrote:

FITZTWINS- yes we go to Karmonos as well! How many treatments have you received?

OHdaughter7

Dx 3/2005, Stage IV, mets, HER2+
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Mar 14, 2011 06:18PM radiant wrote:

Ladies:

Your TDM-1 results, including sdisilvestri's are STUNNING. Wow - Rock star status. I am her2+++. I am currently on Ixempra, etc. However, after reading these posts, I feel like there is more hope than I could have imagined. Between this and the nanotechnologies coming up, I think we are entering a new era of cancer tx. It's AMAZING.

Hugs,
  Kim

Kim, Stage IV, triple +. First dx 2005, stage 3C, mets 2010

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Mar 14, 2011 06:21PM BaseballFan wrote:

I've been so excited reading all the good news about  TDM-1, but from what I'm seeing it is only for HER2+.  Is that the case...or is there another arm to this trial that is for HER2-?

Bobbi

Dx 3/14/2009, 6cm+, Stage IV, 11/14 nodes, mets, ER+/PR-, HER2-Hormonal Therapy 03/20/2009 ArimidexSurgery 07/23/2009 Lumpectomy (Left); Lymph Node Removal: Sentinel Lymph Node Dissection (Left)Radiation Therapy 09/01/2009 ExternalSurgery 10/01/2009 Lumpectomy (Right)Hormonal Therapy 08/01/2010 FaslodexChemotherapy 09/01/2010 XelodaHormonal Therapy 06/01/2011 AromasinChemotherapy 02/13/2012 XelodaHormonal Therapy 07/24/2012 FaslodexChemotherapy 12/12/2012 TaxolHormonal Therapy 01/26/2013 AromasinTargeted Therapy 01/26/2013 AfinitorChemotherapy 10/01/2013 carboplatin, Gemzar
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Mar 26, 2011 11:22AM annfromatlanta wrote:

I am Stage IV, Her2+++ w/ METS to liver, bones, nodes in pelvis & chest wall. I just started progression after almost 3 years of being stable on Xeloda/Herceptin/Zomeda. Does anyone know how I could find a TDM-1 Clinical Trial to participate in? I live in Atlanta. Please feel free to email me... annwertz@yahoo.com

Thanks!

Ann 

Dx 5/11/2008, Stage IV, 3/9 nodes, mets, ER-/PR-, HER2+
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Mar 26, 2011 12:12PM radiant wrote:

Here are the Extended Access Program sites for tdm-1:

http://www.clinicaltrials.gov/ct2/show/NCT01120561

- Kim

Kim, Stage IV, triple +. First dx 2005, stage 3C, mets 2010

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Apr 19, 2011 04:19PM annfromatlanta wrote:

Thanks for the site info, Kim. I applied for the T-DM1 trial in Charleston. It was between there and Nashville, the two site locations closest to me. The clinical trials director there (in Charleston) is really on the ball and had me in there for the trial in no time. I had my first treatment exactly one week ago today. I went into my local oncologist's office today for labs. A requirement to be on the trial is to get lab work each week that you don't get the treatment, at least between the first 4 treatments. The treatments are every 3 weeks, indefinitely. The side effects have been minimal, so far. I've had bouts of fatigue, some neuropathy, abdominal pain and light nausea, but all these symptoms should improve after the first 2 weeks. At worst, I might have the symptoms after the 2nd treatment, but I think (?) not after that one. The treatment center is phenomenal, just opened in October, and the people who work there could not be nicer. The doctor is attentive, professional and young (age 35), so I figure I'll retire before HE retires (ha-ha!). I could go on and on, but basically, it was a really great & better than expected experience. Ann

Dx 5/11/2008, Stage IV, 3/9 nodes, mets, ER-/PR-, HER2+
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Jun 14, 2011 05:26AM windlass wrote:

I'm in the current "early stage" TDM1 trial.

I had my first infusion last week. I believe I got every one of the side effects, which I was told would be "mild." Blinding headache, excruciating back ache, "fatigue" (debilitating exhaustion), flu-like symptoms, lack of appetite - yecch. After groaning in agony from the headache and back ache on Day 1, I slept for 36 hours straight Days 2-3.

It's worth every bit of it if it keeps the cancer at bay, though.

"He will cover you with his feathers, and under his wings you will find refuge." -Psalm 91 . . . . . . . Completed: UniMX, DIEP reconstr; A/C x 4; TDM1 x 4; Taxotere+Herceptin x 4, 33 Rads; TDM1 Phase II Trial x 9; Tamoxifen, prayer.

Dx 1/18/2011, IDC, 6cm+, Stage IIIc, Grade 3, 12/28 nodes, ER+/PR+, HER2+Radiation Therapy External
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Jun 21, 2011 11:54PM sam1 wrote:

Hi i will be going to the Nassau tomorrow for tests to see if I can go on the trial. They want to to blood work and check my heart. Then if that works out ok, they will send me to Miami for the day for CT scans and bone scans.  My question to you ladies that are already on the trial is, did you get your treatments done every 8 days or every 21 days. Thanks for all your great info

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Jun 22, 2011 01:00AM ma111 wrote:

Readywowin,

I am a Pittsburgh person also. Currently in a vaccine trail at the NIH. Magee is where I had my surgery and rads.

Good to hear the the TDM1 is working, maybe I will do that next. Is it still open? What the number for contact?

I aslo like reading about the small amount of side effects.

Dx 8/4/2009, IBC, <1cm, Stage IV, 19/19 nodes, ER-/PR-, HER2+