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Using metformin?

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KatieMarie View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote KatieMarie Quote  Post ReplyReply Direct Link To This Post Posted: Apr 24 2011 at 5:48pm
Hi all,
 
I got my thyroid doc to prescribe metformin, 500mg twice daily.  I brought in the articles about it related to breast cancer and the clinical trial.  He had heard about it already.  He is a family doc, but he definitely is a doc that thinks "outside the box."   We are testing liver/kidney function in three months.
 
Blessings...
 
 
IDC dx 4/24/09, Age 40
Two surgeries, three tumors: 1.4cm,4mm,2mm; Ki67=75
Stage 1, no node involvement, clean margins
BRCA 1/2 negative,
Chemo: AC dose dense then Taxol dose dense, then rads
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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 8:04am
My onc is reluctant to prescribe metformin outside a clinical trial.  Has anyone heard of the Canadian Metformin trial expanding to the states?  Are there any other adjuvant metformin trials available today for breast cancer?  
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 LauraT Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 9:13am
My onc wouldn't give it to me either. I saw on the LBBC interview with Dr. Rugo that the trial in Canada would be expanding to the US "soon." I wonder what the timing is? Seems like soon is never soon enough!!  I've thought about seeing how much it would cost to get my insulin levels checked. My grandfather was diabetic and he had throat cancer.
DX 10/09 @44, Stage I IDC tnbc, DCIS other side, Neoadjuvant TCx4, Bilateral Mastectomy w/Recon 1/10, 1.2cm 0/7 Nodes, 5/11 Mets to Lungs/Lymph Nodes, Avastin/Taxol, 10/11 Bone Mets, Xgeva
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 9:32am
Laura,

My onc told me the study will be expanding to the US, but there are some problems with distribution of the drug.  I don't know what that means unless it could be that since the study is coming from Canada then the Metformin would have to be distributed across the border?  Just speculating.  I don't know what time frame "soon" is either, but hope to hear more about this study.

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 TNinTN Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 9:40am
Susan's oncologist is running the metformin trial at Vanderbilt and suggested that Susan consider participating last February. At that time they were having some trouble getting the trial drugs across the border from Canada. It seems that customs didn't like the way the drugs were labeled. UGH! We will be going back to Vanderbilt tomorrow and hope to begin participation in the trial. I noted, however, that Hope Rugo's responses to questions on the LBBC site last month indicated that the trial was still not yet up and running in the U.S.
 
I did a clinical trials search at the breastcancertrials.org site and called TNBCF trials search and was dissappointed to learn that there are only three trials Susan is eligible for at this point (including the metformin trial which did NOT come up on either search). The two trials that came up on the searches were the MUC1 vaccine trial in Cleveland, OH and one for denosumab in Jacksonville, FL.
 
Does anyone have any thougths on these?
 
Martin
Wife age 53@dx TN IDC Stage IIA 7/10; BRCA1&2 Neg; BROCA Neg; LN Neg; taxol+cisplatin+/-RAD001x12(clinical trial); lumpectomy 12/10;ACx4; 33 Rads complete 4/11; NED 5/5/11
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Post Options Post Options   Thanks (0) Thanks(0)   Quote TracyAMac Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 10:46am
Hi - I will ask the Clinical Trial Coord. here in Toronto when I see her May 24 about status of getting the drugs to the U.S. Metformin has been around forever and is inexpensive, so I don't get why there is a problem.  I understand  that it does not have the backing of a pharma. - maybe that has something to do with it.  One of the reasons I decided to go on the trial is because it was advertised to be a very large, Phase III North American wide study!!!  The more that are on it the better - e.g. if good results are shown before the 5 year study is up, they could "un-blind" it earlier.

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: May 04 2011 at 11:19am
Martin,

I was given the same information about trouble getting the drug across the border.  I hope they get this worked out soon so the trial will be available here. 
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 LauraT Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 11:38am

Martin - I sent all my records up to Cleveland for the MUC1 trial but was not accepted (maybe because I have had scans that show something that needs to be followed). There is someone here whose daughter is participating in that one. It's probably in the TNBC talk section somewhere.

Please let us know what you find out at Vanderbilt. I hope that you find something for her. When I finished treatment, there were no trials available for me and it was so frustrating! I missed one trial (up at Harvard) because it took them so long to get funding and get started. Now I am too far out from surgery.
 
Laura
DX 10/09 @44, Stage I IDC tnbc, DCIS other side, Neoadjuvant TCx4, Bilateral Mastectomy w/Recon 1/10, 1.2cm 0/7 Nodes, 5/11 Mets to Lungs/Lymph Nodes, Avastin/Taxol, 10/11 Bone Mets, Xgeva
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Charlene Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 11:48am
Martin,
I also sent all my records to the Cleveland trial for MUC1, but never heard anything back from them.  I understand from the mother who has posted here a few times that the initial group that was accepted was extremely small, something like only 17, I think.  If they had any success in building up the immunity, they planned to add more participants.  Best wishes.
 
Charlene
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Stage 1, Grade 2, Multifocal; Lumpectomy/re-excision
SNB 0/4 nodes, BRCA-; Taxotere/Cytoxan X4, 30 rads
3/14:NED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote LauraT Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 11:57am
Charlene - just realized you live in Atlanta. Hi Neighbor! I live in Johns Creek. Maybe we could meet for lunch someday.
 
Laura
DX 10/09 @44, Stage I IDC tnbc, DCIS other side, Neoadjuvant TCx4, Bilateral Mastectomy w/Recon 1/10, 1.2cm 0/7 Nodes, 5/11 Mets to Lungs/Lymph Nodes, Avastin/Taxol, 10/11 Bone Mets, Xgeva
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 12:28pm
Tracy,

We'd appreciate any information you can find out about this study being expanded to the US.

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 Charlene Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 1:22pm
Hi, Laura,
 
That would be fun!  I am recently retired, so I have a pretty open schedule.  I actually live in Douglasville, about 45 minutes from downtown Atlanta.
 
Charlene
DX 3/10 @59 ILC/TNBC
Stage 1, Grade 2, Multifocal; Lumpectomy/re-excision
SNB 0/4 nodes, BRCA-; Taxotere/Cytoxan X4, 30 rads
3/14:NED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote LauraT Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 2:23pm

I'll send you a message so we can plan something!

DX 10/09 @44, Stage I IDC tnbc, DCIS other side, Neoadjuvant TCx4, Bilateral Mastectomy w/Recon 1/10, 1.2cm 0/7 Nodes, 5/11 Mets to Lungs/Lymph Nodes, Avastin/Taxol, 10/11 Bone Mets, Xgeva
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Post Options Post Options   Thanks (0) Thanks(0)   Quote TNinTN Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 4:47pm
Our appointment tomorrow is in the afternoon and unfortunately it's a six hour round trip drive from where we live (which has been worth every minute). I'll let you know what we find out when we get back home tomorrow night.
 
Martin
Wife age 53@dx TN IDC Stage IIA 7/10; BRCA1&2 Neg; BROCA Neg; LN Neg; taxol+cisplatin+/-RAD001x12(clinical trial); lumpectomy 12/10;ACx4; 33 Rads complete 4/11; NED 5/5/11
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Barbi Quote  Post ReplyReply Direct Link To This Post Posted: May 04 2011 at 5:45pm
I was seen at my post chemo visit at Vanderbilt today.  I am going to be seen in 3 months and my onc stated she hoped the metformin trial would be going by then so she could enroll me.
Barbi
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Post Options Post Options   Thanks (0) Thanks(0)   Quote TNinTN Quote  Post ReplyReply Direct Link To This Post Posted: May 06 2011 at 12:30am
Our oncologist told us today that the metformin trial is still on hold because the FDA won't allow the metformin or the placebo to come into the U.S. from Canada. She was hopeful, but not optimistic, that the problems would be resolved by July. Susan will no longer be able to participate after July because you must begin within one year of diagnosis. It is difficult to understand why the FDA is creating such a problem since metformin has been around for years. I wonder if politics are somehow involved??? Apparently no U.S. drug manufacturers were willing to produce the drugs for the study, but a Canadian company offered to do so. Now, for reasons that remain a mystery, the FDA won't allow them to ship the drugs here for the trial.
 
Argh!
 
Martin
Wife age 53@dx TN IDC Stage IIA 7/10; BRCA1&2 Neg; BROCA Neg; LN Neg; taxol+cisplatin+/-RAD001x12(clinical trial); lumpectomy 12/10;ACx4; 33 Rads complete 4/11; NED 5/5/11
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 06 2011 at 9:27am
Martin,

This is deeply disturbing to all of us looking for some adjuvant therapy to help prevent a recurrence.  My understanding is Metformin is available in the US as we've heard others getting the drug off label.  So I guess the problem is no US drug company is willing to participate in the trial and offer the drug for free and the FDA won't allow the Canadian manufactured drug cross the border?  What a sad day for all of us.

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 KenR Quote  Post ReplyReply Direct Link To This Post Posted: May 06 2011 at 11:55pm
Please send me copies of the reports you mentioned.  Thank you in advance!
Ken
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Post Options Post Options   Thanks (0) Thanks(0)   Quote zoomommy2 Quote  Post ReplyReply Direct Link To This Post Posted: May 06 2011 at 11:59pm
Could the patient simply pay for the Metformin?  It's not very expensive at all!  Like Martin said, it's been around for years.  My husband takes it!
Lee in Denver
dx6/09,stageII,gr3,(L)mastectomy 7/09,ACx4,Taxolx7,Avastin study,gall bladder surgery 1/10,4/11 Stage 4, mets to lung, 4/11 Started Taxotere and Xeloda, 5/11 Taxotere stopped, off Xeloda
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 08 2011 at 9:44pm
Lee,

I think the problem is for the Canadian Metformin trial to be expanded to the US, they have to have consistency with the drug.  So unless they can figure out how to get the Canadian Metformin distributed to the US, we're up the creek without a paddle!  Unless the docs will prescribe this off label, it seems like it's not an option for us.

When I was on the Bisphosphonate study and chosen to the Clodronate drug.  It came from Canada and was only given to me through the clinical trial coordinator at my oncs office.  When I had the recurrence and had to leave the trial, I had to return the unused Clodronate.

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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