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Old 09-03-2011, 02:59 PM   #1
Lani
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Thumbs up People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Nature Reviews Drug Discovery 10, 648 (September 2011) | doi:10.1038/nrd3538

Trial watch: ERBB2 dimerization inhibitor meets end point in breast cancer trial

Preliminary results from a Phase III clinical trial of pertuzumab, an antibody that prevents dimerization of the ERBB2 (also known as HER2) receptor with other ligand-activated ERBB receptors, have shown that the drug significantly extended the progression-free survival of patients with ERBB2-positive metastatic breast cancer.

In the CLEOPATRA clinical trial, 808 patients with previously untreated metastatic breast cancer were treated either with pertuzumab plus trastuzumab (Herceptin, Roche/Genentech) and docetaxel chemotherapy or with trastuzumab and docetaxel. Although no comprehensive data have been released yet, Roche has announced that it intends to seek regulatory approval for pertuzumab based on the results of this trial.

“Pertuzumab is very likely to be a milestone in the treatment of ERBB2-positive breast cancer for a number of reasons,” says José Baselga, Associate Director of the Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA, and principal investigator of the CLEOPATRA trial. “To begin with, it is likely that pertuzumab in combination with trastuzumab and docetaxel will be the new standard of care as a first-line treatment in patients with metastatic breast cancer. This combination is superior to the standard trastuzumab and docetaxel, with very minimal — if any — additional side effects. In addition, a clinical trial of pertuzumab as adjuvant therapy (postoperative) is just starting (ClinicalTrials.gov identifier: NCT01358877), so pertuzumab could also change the way we treat breast cancer in the early disease setting.”

Pertuzumab is very likely to be a milestone in the treatment of ERBB2-positive breast cancer for a number of reasons

Although both pertuzumab and trastuzumab bind to the same receptor tyrosine kinase — ERBB2, which has aberrant expression or function in breast cancer and is associated with poor prognosis — the antibodies function through different mechanisms.

“The ERBB family of receptors have four extracellular domains. Trastuzumab binds to domain IV of the ERBB2 receptor, whereas pertuzumab binds to domain II — the so-called dimerization arm,” explains Nancy Hynes, who studies the molecular basis of breast cancer at the Friedrich Miescher Institute for Biomedical Research, Basel, Switzerland. “Domain II is the domain that interacts with the other ERBB family members — epidermal growth factor receptor (EGFR), ERBB3 and ERBB4 — when they are ligand-activated.”

Importantly, pertuzumab blocks interactions between ERBB2 and ERBB3, which together form the most potent dimer of the ERBB family in initiating oncogenic signalling. Moreover, unlike trastuzumab, pertuzumab has the potential to function in tumours with normal levels of ERBB2. However, Hynes notes that the antibody might be less effective in tumours with active EGFR, given that EGFR homodimers can signal without the help of ERBB2. Another advantage of pertuzumab lies in the fact that it interferes with ligand-activated ERBB2-containing complexes, which means that the drug could work in ERBB2-positive tumours in which trastuzumab alone is ineffective. “In ERBB2-overexpressing tumours, one mechanism that could contribute to trastuzumab resistance is co-expression of heregulin or any of the other ERBB ligands. Based on the promising results of combining trastuzumab and pertuzumab in ERBB2-overexpressing breast cancer, we can hypothesize that the ability of pertuzumab to disrupt ligand-activated ERBB2-containing complexes contributes to its activity.”

Given the success of this trial, which investigated a combination of two antibodies, it is possible that combination therapies that target more than one component of a signalling pathway could become more widespread. Indeed, as Baselga points out, “The demonstration that combined ERBB2 blockade with two antibodies may be superior to therapy with just one antibody has implications that extend far beyond ERBB2, as the concept could also be applied to the targeting of other receptor tyrosine kinases.”
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Old 09-03-2011, 03:42 PM   #2
StephN
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Thanks, Lani -
Looks like what the experts have been theorizing for a few years now is coming to fruition.

I love the name of the trial - Cleopatra was a woman to be rekoned with, and so will this drug combination.

I hope some of our sisters here who are beyond the first line in their mets fight will be able to benefit off label or however.
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Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
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Old 09-03-2011, 04:38 PM   #3
chrisy
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

i've had a few conversations with genentech researchers involved with the development of pertuzumab, some who were also on the tdm1 development. Those folks really know their stuff; and when they get excited, I get excited. Steph, it is definitely another step towards the 'total blockade" appoach we've been hearing about over the years.

Hurry up, please!
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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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Old 09-03-2011, 04:52 PM   #4
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

At ESMO late September, Roche will also release data from a two armed phaseII trial of T-DM1 vs Trastuzumab/Docetaxel, results of an evaluation which they're very excited about. The now ongoing international phaseIII trial Marianne, follow-up of this completed phaseII, was given a third arm consisting of T-DM1 and Pertuzumab.
Hopefully results from this combination show that Pertuzumab is synergistic in this setting and thus help further improve on standard of care as a first-line treatment in patients with metastatic breast cancer
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Old 09-03-2011, 11:59 PM   #5
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Thank you all for that info.Bring it on! The total blockade approach is yet to be embraced by the Australian Pharmaceutical Benefits Scheme but I fear that has more to do with economics than science.I'm so glad to have benefit of your experience and contacts.
Trish
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5/2004 (R) 30mm bre gr3 infiltrating ductal ca 16/18nodes er (2+) pr (3+) HER2 (3+)
6/2004
6 cycles(FEC), Oct 40 rads, Tamoxifen
5/2006
oopherectomy, Arimedex
12/2006
liver mets largest 9cm
1/2007
Herceptin,
3/2007
Taxol + Herc
1/2008
Herc alone
4/2008
Multiple bone mets,Zometa
7/2008
Herc + Gemcitabine
8/2008
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10/2008
Herc+Carboplatin+Taxol
12/2008
Tykerb+Xeloda
2/2010
Herceptin + trial drug
5/2010
Herceptin+Tykerb
8/2010
Tykerb+Abraxane
9/2010
Abraxane
12/2010
Abraxane+Tyk+Herc
4/2011
Tyk+Herc+Femara
6/2011
Liver and bone mets prog.Abraxane continue Herceptin,Tykerb,Femara and Zometa
8/2011
Probable liver progression and increased neuropathy. Xeloda with Tyk+Herc. Zometa 6 weekly.
9/2011
Liver progression,TM +++. Cyclophosphamide and Methotrexate metro Herc Zometa
10/2011 liver mets prog.Herc, 3 Tykerb +2mg decodron daily,Zometa
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Old 09-04-2011, 12:07 AM   #6
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Thanks all for the info.But when we will gwt them here in India is what I am wondering.
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Metstatic Breast Cancer Stage 4
Left breast cauliflower 25x20cm
ossousmetstatis in vertbrae secondaries L4=L5secondary
nodules in both liver lobes secondary
Diagnosed 10th March 2010
ER/PR-ve
Her 2 neu +++
Taxotrne Zylotec started 16th March
Herceptin added 5th April.9th Herceptin over on 20th Sep '10.Started on Tykerb and Xeloda on 22nd Oct2010TYKERB 4 TAB A DAY XELODA 4 TAB A DAY ONE WEEK ON ONE WEEK OFFZoletrust infusion every 4 months.Lesion in Brain 3D CRT Radiation started on 1st Feb'12 for 20 days ,5 days a week for 4 weeks.Devloped a small lump in breast.Xeloda stopped from 11th April '12.On Taxol.After 3 cycles of Taxol Taxol stopped.Back to Xeloda regime from 3rd July
Herceptin started again on 27th Dec 2012.Xeloda stopped Navelbin added on 7th February 2013.Now on Tykerb Herceptin and Navelbin
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Old 09-04-2011, 12:39 AM   #7
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Thank you for this piece of information,

I can't wait to see the results of the trials.
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She has been dignosed in February 2008 BC state IV, left breast multiple nodes size 5 cm, mets lungs and liver. Er+ Pr+ Her neu +++.
3/2008 - 10/2010 Herceptin + Aramidex NED
10/2010 recurrence lung met, pleural effusion, toracentesis
11/2010- Tyverb + Navalbine NED
08/2011 CA-15-3 = 90 scan
08/2011 Scan revealed reccurrence lung met, tiny metastasis on the pleura and pleural effusion.
4 pills tyverb, mytoxantrone once ever three weeks, and Aromasin.
Tykerb and taxol, sever allergic reaction
Tykerb taxotere
Herceptin, perjeta, gemcitabina
C- diff, bad diarrea
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Old 09-04-2011, 04:50 AM   #8
Ellie F
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Thanks Lani
Another bit of good news. I hope as Chrisy has suggested that it is also synergistic with T-DM1. I am wondering how long it will now be before this is approved in the States because we then have a chance of getting it approved by NICE here in the UK!

Ellie
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Old 09-04-2011, 07:30 AM   #9
Lori R
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Lani,
Thank you for posting such an encouraging news item. I am so excited by posts that indicate we have yet another weapon available to us!!

Chrisy...thanks for chiming in as I knew you have some direct insights that few of us have. When all those smartie pants researchers get excited I can't help but remain hopeful.

This post also explains why my onc recently mentioned pertuzumab. Another good sign that my onc is "on it".

I go forward with an extra dose of hope for a beautiful labor day weekend. Thank you for the gift of hope!!!!
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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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Old 09-04-2011, 11:28 AM   #10
Ellie F
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Hey Lori,
My onc talked about pertuzumab a few months ago and was also very upbeat! It made me think that there was some good news about it then especially when he talked about having some pts in trials here in the UK doing well.
Ellie
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Old 09-04-2011, 11:45 AM   #11
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Our pipeline is flowing with amazing breakthroughs. Hope these results helps P-mab make it through the FDA maze sooner rather than later.
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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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Old 09-04-2011, 03:58 PM   #12
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Wink Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

One of the docs where I go told me the Petuzamab is even better than Herceptin !!!!!!! He expects it to be approved soon after the FDA application is filed. I hope so for everyone's sake.
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Old 09-04-2011, 04:56 PM   #13
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

I have also seen that it crosses the blood brain barrier like tykerb and is presently being used in Lung cancer that goes to the brain.
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Nov 2009 X3 Taxane and Herceptin, X3 FEC
March 2010 25 Rads
March 2010 continued on Herception untill 16 Dec 2010
May 2010 Ultra Sound .... ALL CLEAR... NED
August 2010 started vaccine trial University of Washington
7th Dec 2010 finished vaccine trial
20th Dec 2010 Port removed
3rd Feb no longer ned brain mets
23r Feb start VMAT radiation
August 2011 two new mets to brain and others starting to grow again !!!!
August start tykerb and xeloda
Dec 1 MRI all small brain mets gone. Largest shrunk by 50% only three small ones to go 17mm,8mm,6mm. Mets on there way out. Yeah
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Old 09-04-2011, 05:10 PM   #14
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Science once again gives us hope! As former researcher myself, I can say that there were a ton of people and research animals that put their lives into each new therapy that comes down the pipeline. Hopefully you all understand the importance of animal research, as every therapy at some point is tested on animals for one reason or another.
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Aug 2010: diagnosed stage 3b, 4 mo. after birth of son. 29 yrs old and breastfeeding, ER/PR-, Her-2+ started Neoadjuvant therapy: 4x FEC, 10x abraxane & Herceptin
Feb 2011: L mx with recon. Path. showed only DCIS but 4/10+ nodes.
March 2011: 6 wks rads.
Mother passed, lower back pain.
Late May 2011: Bone mets but organs clear; Tykerb, Xeloda, Xgeva. Stopped Herceptin. Implant infected: removed implant.
October 2011: Bone progression; Gemzar and Carboplatin & restarted Herceptin.
Jan 2012: Progression, re-classified as ER+; Tykerb, Herceptin, Zoladex & Femara. Anti-E is working!
May 2012: ovaries out, markers stable but elevated. Cont. Herceptin, Tykerb, Xgeva & Femara.
Dec 2012: aromasin
Jan 2013: faslodex, herceptin, tykerb
Jun: Kadcyla
Aug: Rads to hip, then Perjeta, Herceptin & Taxotere
Nov 2013: Perjeta, Herceptin, Halaven
Early 2014: Affinitor, Aromasin, Perjeta, Herceptin.
June 2014: Estradiol, Perjeta, Herceptin
Aug 14: Tamoxofin, H & P
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Old 09-05-2011, 08:10 AM   #15
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

RE: Research Animals
I for one am grateful. I told my oncologist that I planned to buy one of those bricks that some hospitals sell and have it carved with "In gratitude to all the laboratory rats that sacrificed their lives for medical research." Haven't done it yet.
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IDC, Stage I, Grade 2
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Lumpectomy 11/04/05 Clear Margins
3 Dose dense AC (Couldn't tolerate 4)
4 Dose dense Taxol & Herc. (Tolerated well)
36 weeks Herceptin (Could not complete one year due to decrease in MUGA score)
2 years of Arimidex, then three years of Femara
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Old 09-05-2011, 08:48 AM   #16
Lani
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

Kiwi girl-- Do you remember where have you seen that it crosses the blood-brain barrier?

My understanding is that is a large molecule, like herceptin which does not cross the BBB, where as small molecules like Tykerb do. Would be happy to have my understanding corrected!
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Old 09-06-2011, 06:40 PM   #17
Laurel
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Re: People get ready there's a train a'coming... news on pertuzumab, Cleopatra!

MJo, you cracked me up with your "ode to all the rats I have known and loved..."
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Dx'd w/multifocal DCIS/IDS 3/08
7mm invasive component
Partial mast. 5/08
Stage 1b, ER 80%, PR 90%, HER-2 6.9 on FISH
0/5 nodes
4 AC, 4 TH finished 9/08
Herceptin every 3 weeks. Finished 7/09
Tamoxifen 10/08. Switched to Femara 8/09
Bilat SPM w/reconstruction 10/08
Clinical Trial w/Clondronate 12/08
Stopped Clondronate--too hard on my gizzard!
Switched back to Tamoxifen due to tendon pain from Femara

15 Years NED
I think I just might hang around awhile....

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