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tania View Drop Down
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    Posted: Feb 16 2011 at 4:11pm

I am interested in connecting with anyone who is currently taking metformin.  I am aware of the large randomized trial, but am most interested in trying to get this prescribed for an "off label" use where I know for sure that I am getting the drug.

The initial data is compelling and I am looking for find a medical doctor that supports this, will write the prescription and who will monitor me for possible side effects.  Preferably in the greater San Francisco bay area. Oncologists recommend the trial only.  An integrative doc of UCSF has prescribed for others, but has not been very encouraging of this approach for me.
 
Any input and information is most appreciated.  thank you!
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote cheeks Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 4:18pm
I have taken Metformin for my diabetes for the last 6 years - didn't stop me from getting TNBC - how is it supposed to help with breast cancer?
Lump found 11/08
DX: 2/09 @52 TNBC
L. Mast. 3/26/09, SN-, BRCA-,
4.5 cm (post surgical)T2NOMO
Chemo: 4/09-10/09 Taxol x 12,
A/C x 4, No rad.No recon. NED 1/17. New Primary right breast TN, 2/2018.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 4:23pm
Tracy, one of our members, is in a Metformin trial.  Here's the thread talking about it.

http://forum.tnbcfoundation.org/metformin-clinical-trail-info_topic7434.html?KW=metformin

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 4:26pm
Donna you beat me to it, was wondering why my post wouldn't go through! As we all know there is no magic bullit to prevent getting bc, and certainly no one would suggest that metformin has the ability to be that bullitt, but the studies have been suggesting a strong connection when metformin is used to improve the efficacy of chemo itself when given at the same time.
 
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 4:35pm
Mainy,

Ha, maybe we're twins?


DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 4:37pm
I wish!
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote TracyAMac Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:08pm
Hi Tania, Cheeks,  Donna and Mainy

Many times I have been asked why can't I just get Metformin prescribed to me by my dr/onc/whoever?  If you ask, the answer is that is usually given is it would be crossing a medical-ethical line as Metformin has not yet been approved for BC treatment or prevention in most if not all areas.  The clinical trial environment has strict eligibility criteria, pre-trial blood screening tests and obligations to continued testing and check ups during the 5yr trial that are submitted to the central trial investigators so  that they can consistently monitor and assess any correlations between the trial drug and BC recurence. If the are huge success or failures during the trial they might "unblind" the study before the 5 years are up.

Mainy, I haven't heard about Metformin being administered with chemo. - is that part of clinical trial or something else?

I was also on a small pre-surgery Metformin trial for a few weeks (not double blind) to see if it could shrink or slow the growth of tumors before surgery. . Even though the group size was small I was told that the results of the trial will not be published for a couple of years - I hate waiting!!!

Tracy in Toronto 
TN&non-TN tumors April/10 Gr3&2;1 metaplastic
Rmast.1/9 nodes w/isolated t.cells
Taxotere&Cytoxan x6
Bone cancer 1980 age17;surgery&chemo AC+Methotrexate
BRCA-ve
On hormone therapy & Metformin Trial
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Post Options Post Options   Thanks (0) Thanks(0)   Quote tania Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:32pm

The research abstracts I have muddled through suggest that it can make chemo more effective (with the exception of platinum based drugs, which it can possibly diminish the effects of).  The large trial (CA-32 or MA-32, I think it is referred to) is for folks who are completely done with chemo.  I am not sure I understand exactly how it works, but metformin may have an anti-angionesis effect.  There are some studies that show it is most effective in TNBC lines (in mice and in culture - no human trials).  All looks good, but this is why I am interested in finiding someone with medical credentials to try and help me make sense of the studies and see if the data really is compelling enough to try and "go rogue" with this one and get the drug outside of the randomized trial.

I know of at least one oncologist at Mt. Sanai who is writign prescriptions off label as he beleives the possible benefits far outweight the risks. He won't take me on as a patient/consult, though.
 
Cheeks - the initial finding was discovered at MD Andersen that showed that diabetics on metformin showed better response to chemo than diabetics on something else.  Then that led to looking at the drug's effect on non-diabetics.
 
I am happy to send the abstracts to anyone interested in reading.  Just send me your email address.  I have electronic versions but no online links.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:34pm
Tracy,

I was told a while back the same thing you just said.  Prescribing Metformin for breast cancer patients outside of a trial, would be considered off-label for the drug and most doctors won't cross that line.   This could all change with trials like the one you're in if Metformin is approved for use for breast cancer.  The tough part is waiting for these trial results to be released!

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote tania Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:39pm
Five years is a long time to wait for those of us trying to get this behind us and never see it come back!  I will probably sign up for the trial if I can't find a doc who feels strongly enough about this.
 
Donna - I am also on a Gem/Carbo/PARPi trial.  I am at Stanford for the early stage, phase II trial.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:45pm
Ok, Tania - fess up:  what do you do for a living?   :)

d (also a science geek)

*why won't the Mt Sinai guy pony up?
DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 5:45pm
Tania,

We have a couple of threads for those of us on the Parp trials.  Maybe you can give others an update on your experience with it so far.

Here's the links:

http://forum.tnbcfoundation.org/good-scans-on-parp-trials_topic7810.html

http://forum.tnbcfoundation.org/very-disappointing-news-iniparib_topic7864.html

Donna






DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote johnmc Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 6:34pm
Hello all,
My wife - tnbc with mets to mediastinum - has been on metformin for around a year now. Current dose 500mg twice a day.
When studies first came out suggesting metformin may have beneficial effect on breast cancer, I mentioned this to our oncologist and suggested that because my wife was TNBC and because metformin is so inexpensive and because there were no real good treatments, akin to herceptin,for TNBC, Might it not be worth trying.   He agreed. We started at 500 mg once a day for awhile to make sure my wife could tolerate and now she is on 500mg twice a day. She is not diabetic and has no side effects on the drug. She also is not overweight.
Parenthetically, drugs are used ALL THE TIME -for off label reasons. For example, beta blockers and calcium channel blockers are used for migraine prevention, antidepressents are used for chronic pain,sleep disturbances and fibromyalgia. Beta blockers are used for certain tremors. These are all off label uses. These uses are not illegal nor unethical. Many of you may have taken Claritin when given Neulasta shots. This works terrifically for the bone pain of Neulasta and is fairly widely used. This also is an off-label use. That would be an example to share with oncologist who says "I can't do it" because "it's unethical".
I would suggest to your oncologist that if you would like to try metformin to discuss trying it at a low dose and increasing if tolerated. Tell them you would agree to sign a statement stating you would not hold them responsible for this off-label use should you experience side effects. Most oncologists are not familiar with using metformin. This reasonably would make them nervous about using it. Possibly the oncologist would be okay if a clearance was gotten from your family doctor, but I think a release would go a long way in calming malpractice nervousness. The statement I like ( I did not invent it) - "the side effect of metastatic TNBC is death"............that kind of puts it in perspective.
One VERY IMPORTANT FACT about metformin. If you have any decrease in kidney function - can be monitored by BUN/creatinine levels - metformin should NOT be used. Certain chemos can cause kidney problems so these tests should be monitored before and during metformin use. This is very important and something an oncologist may not be aware of. Remember they don't use metformin on a usual basis, so they probably feel uncomfortable using it.
So in a nutshell, it's not so much "it's unethical" - it's more I'm not used to the drug and I'm uncomfortable using it, which you can understand. BUT working with your FP, monitoring kidney function on a regular basis, signing a waiver holding the oncologist harmless - all these would probably help grease the wheels if you want to go the metformin route.
I hope some of this helps. I truly believe for my wife- that if there's any chance that taking metformin will help keep her cancer at bay - it's worth it.
 
John
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 7:24pm
John,

Thanks for your perspective and guidance.  I never thought about the anology of off-label use like Claritin for the Neulasta shot.  It makes sense and so does your suggestions for talking to our oncs.  In light of the most recent research from the Jefferson KCC, metformin is in the news again.

http://www.eurekalert.org/pub_releases/2011-02/tju-jrp021011.php

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote TracyAMac Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 7:32pm
Thanks Tania for your info - good to know

John you raise some compelling points for the off label use of Metformin and I agree many doctors are unaware of the drug.

What I and others have been told is that the "ethical" issue for many doctors is that  prescribing a med.  that has primarily used for only one specific disease, especially one that is has not had much prior research for expanded use - it's not backed by a pharma., thus the low cost-  and knowing that  that controlled trials are currently in progress for this drug is crossing a professional line.   It is unfortunate when we look at how fast Viagra went from being used for heart issues to approval for  its current main use.

Recommending over the counter meds. to manage side effects or  prescribing more generalized drugs that have been medically proven to help with side effects is viewed as something different..  Also, in some hospitals, especially those with a research/teaching  component they usually  have to "follow the book" - no exceptions without going through a formal appeals process. My onc. had to do this to get extra cycles of TC for me  because I could not have Adriamycin, having received the life time limit of it for another cancer 30 years ago. Even with two different tumors (one metaplastic) and Li Fraumeni Like Syndrome, he had to jump through hoops. Thankfully, it was approved - in a non research/teaching hospital oncs. can do what they want in terms of extra cycles- hopefully within protocol guidelines! 

In addition to the potential kidney impact, Metformin can cause serious diarrhea and weight loss if not taken at the right dose and/or gradually increased so your advice about starting on a low dose is important.

I admire what you and your wife are doing to fight this terrible disease.

Tracy in Toronto
TN&non-TN tumors April/10 Gr3&2;1 metaplastic
Rmast.1/9 nodes w/isolated t.cells
Taxotere&Cytoxan x6
Bone cancer 1980 age17;surgery&chemo AC+Methotrexate
BRCA-ve
On hormone therapy & Metformin Trial
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Post Options Post Options   Thanks (0) Thanks(0)   Quote johnmc Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 11:03pm
Hi Tracy,
I'd like to  respond to a few of your points.
Metformin - which has approval for treatment of type II Diabetes- is already  used "off-label" in a condition called polycystic ovarian syndrome (PCOS)and has been for years now, so the precedent for off-label use for this specific drug is already there.
I don't know about Canada, but I assure you that no doctor in an outpatient setting - as most oncologists are in the US - would have to jump through any hoops or fill out any particular forms to write a prescription for metformin. The RX could be filled in any local pharmacy and no questions would be asked by anyone.
IF you were prescribing in an inpatient setting, then you MIGHT have to fill out some forms IF the drug was controlled in some way (eg newest restricted use antibiotics) OR if the drug was not on formulary. However in an outpatient setting there is no such oversight and as I said in my previous message many drugs are used off-label already and there is no restriction against doing so. This is not to say a drug could be used willy-nilly without any consequences. There should be scientific rationale for the use and with proper judgement and monitoring - otherwise malpractice could be alleged if untoward consequences occurred. Certainly there is a rational for the use of metformin in someone with metastatic TNBC but then the potential for side effects would have to be weighed against the possibility for benefit. One would have to go into the use with open eyes and proper understanding of potential side effects. Cost with metformin is not an issue. You can  probably get a month supply at WalMart for $4.00 here in the US.
I can give you another example of "off-label" use that would apply specifically to TNBC. Avastin was approved for met breast cancer "when used with Paclitaxil". That FDA approval as you may know has been rescinded. Sanofi is appealing and while the appeal is going on, Avastin is still covered  under many insurances for women who have already been receiving it. Now I know positively that there are women with met TNBC who are kept on AVastin after they complete the AVastin/Taxol treatment in the hope that Avastin alone will keep them disease free. And in fact there is a woman on the Inspire board who has been very vocal on Avastin - started the big petition to keep it approved- who has been on Avastin 2 and 1/2 years and is still NED. She is certainly not alone.
The NCCN guidlines for 2011  and backed by the top centers in the US, still lists AVastin and Paclitaxil as a recommended treatment in met BC.
But here's the point I'm trying to make. Avastin is being used ALONE -as MAINTENANCE therapy- after they go into remission- in those women who respond to it and tolerate it -even though the true indication is to be used "with Paclitaxil".
So technically speaking this is an "off-label" use of Avastin. It is going on because oncologists have found that some women can remain NED once they are put into remissioin by staying on AVastin alone and because some of these women tolerate it well. IT's already going on and it's technically an "off-label" use and the drug is much more dangerous,far less widely studied and 1000xs more expensive than metformin -but it's being done for the most ethical reason of all - to try and keep the women alive.
Keep the fight going !
 
John
 
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote johnmc Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2011 at 11:07pm
Donna,
 
Thanks for the posting re:Jefferson Kimmel Center findings
 
John
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Post Options Post Options   Thanks (0) Thanks(0)   Quote TracyAMac Quote  Post ReplyReply Direct Link To This Post Posted: Feb 17 2011 at 12:27am
Thanks John for your additional notes on this topic. I believe it is the same here in Canada in terms of doctors/family doctors and being able to prescribe Metformin on an out patient basis. My "jumping through hoops" example  is re what usually happens in research/teaching hospitals where there are very strict requirements to follow protocols. As I mentioned, other hospitals often have more latitude.

Based on what we know about Metformin, I wish I could  get a script for it and I would be willing sign a waiver as you suggested.   I and many people I have heard from have not been able to get it so for me, the trial is the next best thing. If I get mets., I will be jumping and screaming for it or whatever best  is available at the time to fight the good fight.

It is frustrating that there seems to be so few trials focused on TNBC and other aggressive forms of BC. When we find one, and qualify for it, the  trial is often long and  randomized. The one I am on is not specific to TN but I am happy they are stratifying participants into different groups including those of us who had tumors were not hormone receptive. 

Tracy in Toronto
 


TN&non-TN tumors April/10 Gr3&2;1 metaplastic
Rmast.1/9 nodes w/isolated t.cells
Taxotere&Cytoxan x6
Bone cancer 1980 age17;surgery&chemo AC+Methotrexate
BRCA-ve
On hormone therapy & Metformin Trial
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 17 2011 at 7:37am
Tracy and John,

I've looked at some of the clinical trials for metformin.  Most of them are for early stage breast cancer and preclude anyone with recurrent or metastatic disease.  I couldn't find a study for women like me or John's wife.  It's unfortunate they are not looking at studies for more advanced bc or specifically the effects of metformin and TNBC.  Sigh, where are the studies for TNBC?

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 28 2011 at 8:31pm

Metformin suppresses metastasis of triple negative breast cancer cells

Last updated: December 5, 2010
News type:
Breast cancer study
Publication:
Oncology Reports, January 2011
Study name:
The anti-diabetic drug metformin suppresses the metastasis-associated protein CD24 in MDA-MB-468 triple-negative breast cancer cells
A new study has reported that metformin reduces the metastatic potential of triple negative breast cancer cells.

http://foodforbreastcancer.com/news/metformin-suppresses-metastasis-of-triple-negative-breast-cancer-cells
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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