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Old 05-17-2007, 06:32 PM   #1
Barbara H.
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Join Date: Sep 2005
Location: Newton, MA
Posts: 951
Trastuzumab-MCC-DM1

Hi,
My oncologist is considering this trial for me. Has anyone used this Herceptin enhanced drug/or planning on entering this trial?
Best regards,
Barbara H.
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Old 05-17-2007, 09:54 PM   #2
Barbara
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Join Date: Oct 2005
Location: Payson, Arizona
Posts: 96
New Trial

Barbara:

I am not familar with the trial and what stage may be elgible Could you tell use more obout it. Thanks.

Barbara
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Old 05-18-2007, 11:37 AM   #3
Adriana Mangus
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Join Date: May 2006
Location: California
Posts: 668
Not sure

You do not have enough information in your profile. What stage are you?. Is it mets. ? Where? Have you run out of options?
__________________
1994 - rt brst, .lump, underarm node dissection,chemo+rad 1.2 cms, Grade 3.
28 nodes neg
Er,Pr, Positive HER2 status unknown
2003- Recur to rt lung.July 16 ( B-Day!)
Her2+++ Er,Pr, Negative
2003 - Aug04--Navelbine + Herceptin
2004- 2007--
NED - Herceptin, only
2007 Feb-April Xeloda added to hereceptin
2007-May Back on Navelbine+Herceptin
2008-Feb-Mar 15 Ses Rad to Rt. Lung
2008- Oc 17 Add Tykerb to Herceptin
2009- June-- Discont Tykerb
2009 July 7--Current Taxol + Herceptin
2009 Dec--Discontinued treatment due to progression. Looking into cyberknife.
2010-Aug Accepted to TDM1, no SE, except liver count went up.
2010-2011 September got kicked out of the trial, due to a small spot found on lung.
2011- 2012 September thru early 2013 on Herceptin
2013- March Bone density shows small spot on 5th rib.
2013 - April 4th appt with onc. will post after discussing course of treatment.
2013-March-April Cyber knife to brain and radiation to rib. Chest --base line before chemo-CT-Scan stable for lung issue. CA2729 Normal.
2013 April Herceptin- TDMI
2013 Sept Herceptin + Perjeta . CA2729 within normal range. Brain and Pet scans October 31st. will post results.
2013 October Brain MRI- mixed response. Will see Onc/rad on Halloween.
2013 October/November Brain-MRI nothing new. Repeat MRI next year in May.

2013 December Continue Herceptin and Perjeta. Stable at the moment.
2014 February Brain MRI -clear!
2014 January Added Taxotere to Perjeta+Herceptin.
2014 March Stopped chemo-chest ct-scan next.

2014- March Scans shows tumor's larger, CA2729 higher. Discontinue Herceptin.
2014 April Perjeta+ Halaven
2014 April CA2729 went down 60 points after one cycle. Cough does not want to go away.
2014 June Continue on Perjeta + Halaven-- no more cough. Stable
2014 June Back on Herceptin + abraxane
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Old 05-18-2007, 01:55 PM   #4
Barbara H.
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Join Date: Sep 2005
Location: Newton, MA
Posts: 951
Trial

I am stage 4 and progressing with bone mets. Originally diagnosed 1998 with 7 out of 9 lymph nodes. May, 2004: 3cm tumor to left pre-frontal cortex, liver, skin, lung mets, and in the nodes through out. After a few rounds of Herceptin I went into remission until February 06 when I developed bone mets. Navelbine and Zometa was added for bone mets. Dropped Navelbine Dec 06.

Description of trial: A phase 1 open-label, dose-escalation study of the sagety and pharmacokinetics of Trastuzumab-MCC-DM1(PRO132365) administererd intravenously to patients with HWE2-positive metastatic breast cancer who have previously received a Trastuzumab-containing regimen.

I am curious if anyone has heard anything about this trial. I have read a few things about it on the internet.

Thanks,
Barbara H.
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Old 05-21-2007, 09:17 AM   #5
vickie h
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Location: san luis obispo, ca
Posts: 1,150
Barbara, I , too, have been reading about this on the internet. It sounds quite promising and certainly worth a trial. I beleive it is going into phase II trials here soon. I know you were on the Tykerb/Xeloda regime. Did it not work for your skin mets? I have been on Tykerb for 2 weeks now and the mets are disappearing little by little. I am also on Xeloda and so far (on my third round) have not had the hand foot thing. This new Herceptin drug looks so promising, let me know where you find the trials and how you are doing. You are always in my prayers. Love, Vickie
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Love and Hugs, Vickie

Life's not about waiting for the storm to pass,
It's about learning to dance in the rain.


Feb 04 IBC IIIC/IV er-/pr- her2+++
3/04 TCH X4
7/ 04 MRM 9/04 Taxol/herceptin wkly 1 yr 33X rads
11/04 skin mets 33x rads,10/05 Avast/Herc. 11 mos.
8/ 06 PET mets lymphs, neck
9/ 06 Navelbine/herceptin
11/ 06 PET NED
2/ 07 skin mets, 4/07 Xeloda, 5/07 add Tykerb
2/ 08 Tykerb failed. Doxil /Herceptin 6 months
8/08 PET skin mets, 8/08 Abraxane/Avastin
11/ 08 PET prog., skin mets
1/09 PET/CT progress, 1/09 Ixempra, 2/09 add Xeloda and low dose Naltrexone
2/09 off Ixempra/Xeloda
3/09 navelbine/herc/cytoxin 4/09 PET shows regress.7/09 start Topotecan. Failed.
8/09 extensive mets rgt brst, back and torso. starting Pazopanib clinical trial.
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Old 05-21-2007, 02:10 PM   #6
Barbara H.
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Join Date: Sep 2005
Location: Newton, MA
Posts: 951
Response to question

I have not had Tykerb or Xeloda. I will be on the trial at the Dana Farber in Boston if I qualify. I am currently NED everywhere except the bones, and hope that this trial will put me into remission everywhere.
Barbara H.
PS: Below is information about the trial that was done weekly:

<table border="0" cellpadding="3" cellspacing="1" width="100%"><tbody><tr class="ccbnBgTtl"><td valign="top">ImmunoGen, Inc. Announces Presentation of First Clinical Data for Genentech's Trastuzumab-MCC-DM1</td></tr><tr class="ccbnBgTxt"><td valign="top"> CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 15, 2006--ImmunoGen, Inc. (Nasdaq: IMGN) announced the presentation today of the initial findings from a Phase I clinical study that evaluates Genentech's trastuzumab-MCC-DM1 for the treatment of HER2-positive metastatic breast cancer. Trastuzumab-MCC-DM1 is being developed by Genentech and uses ImmunoGen's Tumor-Activated Prodrug (TAP) technology. The compound comprises Genentech's trastuzumab anti-HER2 antibody and ImmunoGen's DM1 cell-killing agent. ImmunoGen's TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells.

"We're delighted with the clinical findings with trastuzumab-MCC-DM1 being reported today," commented Mitchel Sayare, ImmunoGen Chairman and CEO. "A primary reason we outlicense our technology to other companies is to enable the development of TAP compounds to antibody targets beyond those available for our own product programs, thus broadening the pool of cancer patients who potentially may benefit from our technology."

The poster is being presented at the 29th Annual San Antonio Breast Cancer Symposium taking place in San Antonio, TX. The presentation is being made by Howard Burris, MD, of the Sarah Cannon Research Institute in Nashville, TN.

The findings presented are from the first seven patients in an ongoing Phase I trial designed to assess the safety, tolerability and pharmacokinetics of trastuzumab-MCC-DM1 given every three weeks to patients with HER2-positive metastatic breast cancer. To qualify for enrollment, patients must have incurable, locally advanced or metastatic breast cancer and must have progressed on a chemotherapy regimen containing trastuzumab (Herceptin(R)). Increasing doses of trastuzumab-MCC-DM1 are given to new patients until the maximum tolerated dose (MTD) is established.

The highest two dose levels that have been evaluated are 2.4 mg/kg and 4.8 mg/kg. The patient receiving the 2.4 mg/kg dose level had an objective partial response (PR) by RECIST criteria.

Dose limiting but rapidly reversible thrombocytopenia was observed in the patient treated at the 4.8 mg/kg dose level. No cardiac toxicity was observed in the seven study patients to date. Enrollment is ongoing to define the MTD for trastuzumab-MCC-DM1 when administered on a three-week schedule.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company's proprietary TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells. Five anticancer compounds are in clinical testing through ImmunoGen and the Company's collaborators - huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, AVE9633 and AVE1642, in development by sanofi-aventis, and trastuzumab-MCC-DM1, in development by Genentech. Amgen (formerly Abgenix), Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor, Genentech, Millennium Pharmaceuticals, Inc., and sanofi-aventis have licensed the right to develop and/or test TAP compounds to specific targets; ImmunoGen also has a broader collaboration with sanofi-aventis.

This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of products by our collaborators, as well as to the Company's development of its own products. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2006 and other reports filed with the Securities and Exchange Commission.

Herceptin(R) is a registered trademark of Genentech.

CONTACT:
Investors
ImmunoGen, Inc.
Carol Hausner, 617-995-2500
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com

Media
KMorrisPR
Kathryn Morris, 845-635-9828
Kathryn@kmorrispr.com

SOURCE:
ImmunoGen, Inc.

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