Metformin-Anyone on this trial?
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M4...if you are under 1 cm in tumor size, it has to be in your nodes. Over 1 cm, it doesnt. That is the reason I got kicked out also.
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Hello everyone, just stumbled across this board. I just started in the trial on July 5. Since then, I've been getting a lot of stomach aches and seem to have to poop a lot more than I used to. Glad to read from this thread that it all seems to be common. I'll be following this from now on!
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YMAC16, how long before the side effects started? I started my trial July 12.
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Ive been invited to participate in the Metformin trial however it seems that the positive correlation between reduced breast cancer for diabetic women on Metformin could have easily been linked to the correlation between women who are overweight having an increased incidence of breast cancer. I hesitate to enter a trial that could cause heart damage, stroke, etc, - which I AM susceptible to - for something that is particularly beneficial for diabetic, or overweight women - which I'm not. I would really value others opinions on this question.
(btw, my profile has moved to stage 3c)
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Gwedolynann, the SEs started within a few days. I'm on Tamoxifen too and I was having occasional stomach troubles after starting it too, so I can't postiviely say that the tummy problems are from the possible Metformin. But, the pooping increase definitely started after I started the trial.
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Bummer YMCA16, as I have NO symtoms what so ever. Oh well, I stressed enough through Chemo and I have only 8 more Radiation treatments to go. My Cancer has a 30% chance of a recurrence and I say "Bullshit"! It's not coming back! Another month and I should be able to go "hat less" . How freakin cool is that? Still waiting on the lashes and eyebrows though! LIFE is good and I am thrilled to be here. Keep posting everyone as I look so forward to reading from each and everyone of you! X O
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Purple32.......Were you turned down .....
I was not turned down m4babies.
Because I didnt do rads ( bad lungs) and have other health issues making endocrine therapy too challenging, I felt this was one of my few options that might prove worthwhile and w/out other tx, I just could not chance placebo.0 -
brady
You said :
"trial that could cause heart damage, stroke, etc,"
Metformin does not have those SEs... but some endocrine therapy does.0 -
Gwendolynann- I am pretty positive I am getting metformin because in the beginning I had a lot of stomach issues. But one truly never knows?????
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I see that there are some women in the Metformin trial that are Stage 1 with negative nodes and still in the trial . I still don't understand why I'm not eligible with Stage 1b (tumor size 1.2cm) and ITC's (considered negative) nodes.
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rn4babies. This is what I know. You have to have had Cancer for less than a year to quilify. I am also a Negative 3 and Grade 3. You have to be all Negatives. ( I think ) My tumor size was 3.2. Maybe ask your Dr. why.
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Im suppose to start the trial next month and I am stage 3 triple positive and 0 nodes.
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gwendolyn.. you do not have to be tripple neg.. i am er+ and Her2+.. but you have to start wihin one year of diagnosis
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rn4Babies,
I tried to get in a study last year and my MO at the time researched and called.... Dana Farber but I did not qualify for the study as a 1a since you had to be a 1c. So I take metformin off label and hope it works.
Good luck,
CR
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RN4babies - if I am reading your diagnoses correct, you have had a recurrence and I think that is what disqualifies you. You probably will need to sweet-talk your PCP into giving it to you.
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I just looked at the criteria and I can't make sense of why rn4babies is not eligible either - though of course we don't know all the characteristics that the MO is looking at. LuvRVing, the recurrence issue shouldn't be a factor because she had DCIS diagnosed first on one side but IDC in the other and the criteria states:
(Subjects with prior invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in either breast are eligible provided the DCIS has been curatively treated including surgery, radiotherapy and/or Tamoxifen).
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Newer paper:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224599/?tool=pubmed
"Current preclinical and clinical knowledge of metformin action suggest that patients exhibiting hyperinsulinemia and tumors expressing the insulin receptor, LKB1, and TSC2 would benefit most from metformin therapy, while patients with normal circulating insulin levels and tumors lacking expression of the insulin receptor, LKB1, and TSC2 would likely be unresponsive to the drug"
There are a lot we don't know. Metformin may have no effect, good effect or bad effect on subsets of BC. Clinical trials set out to find this out. Without accurate data, we may never know.
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ymac16.......My MO didn't know why I wasn't eligible. I got the call from RN in the office that sets up the clinical trials. He told me the only reason I wasn't eligible was because my tumor was a Stage 1b. Had it been a 1c, I would have been eligible. However, see women on here with smaller tumor sizes that are in the study. It was one study I really wanted to participate in. I may try to get my PCP to write for it.0
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So when are insulin receptors in the tumor checked? I don't think mine was checked for that.
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This paper is written by the same dr who is working on the biggest clinical trial on metformin. I expect they would check these tumor receptor/mutations as part of their clinical trial sooner or later to figure out why metformin works or not work for some people.
There are many different receptors that have prognostic and therapeutic implications as we learn more and more about cancer and cancer therapy. Early bc patients have limited samples, so it's best to do the most comprehensive genome sequencing test than sending for different receptor tests piecemeal.
For the people who would not wait for results and refuse being randomized, they could still get a complete genome sequencing. Google "Complete Genomics". The price is dropping fast and now in $xxxx range.
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Hello
I was just clued into this trial todaY by my MO, my last day of tc chemo. I am trying to catch up on all the postings here and through the website for metformin.
It is clear that many of you have moved forward with this choice and have done extensive research. I am stage 2a grade 3 did lumpectomy, tc and soon radiation and probably a hormone med like tamoxafin and was mostly premenopausal.
From your experince, either choosing metformin or not choosing it, would you make the same decision again and why?
Thank you!
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Okay ladies - After researching for the last month, I decided Metformin was something I wanted to try. i spent a lot of time reading everyones posts too. I called about the clinical trial and I qualified. The study is not being done at the medical institution where I am being treated, so I would have to be seen by a new MO at the competing hospital across town, which I was fine with. I did call my MO and asked her opinion. Her exact words were the drug is fairly benign and you shouldn't have any issues taking it, etc....So, then I decided to take it a step further and ask her if she would just prescribe it for me. She said "No, she wont precribe it off label". So after reading all your posts, I decided to ask my PCP, whom I rarely see. They happened to have a cancellation today so I jumped on it and went in for a visit. She gave me 60 samples and had no problem prescribing it to me!!
Part of me is really nervous about taking it. I'm torn. Part of me wants to contribute and be in the clinical trial, but I really want the drug and it will just be my luck that I will get the placebo. UGH! Not sure how I am going to proceed?
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RN4babie...I threw away my info when I was kicked out, but I do know if your tumor was under 1cm, you do not qualify unless it is in your nodes. (mine was 1x1x.8, no nodes). I am a 1b, so that can't be it. They didn't realize mine was a smidege too small until after they brought me in, did the lung xray, all the blood work, etc. I even had the huge bottle of pills in my hands. I had to return it.
I gave all the info to my PCP and he prescribed it. He said it might even help me in the long run as virtually every female on my mom's side is diabetic.
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VVH I am on my first week of the Trail and even though I belive I did not receive the Metformin I am still helping in the long run with other Cancer patients. I'm still hoping that maybe I will not have any side effects and that I am taking the real thing. I just don't know. I wish everyone the BEST and hope our Cancer Monster NEVER comes back!
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Hey wildrumara,
If you feel so torn, please don't join the trial. It's a long commitment on the parts of the ladies who joined, especially for those who may be randomized to nonmetformin.
But please ask about the trial, spread the word about the trial, double check what their randomization ratio: which may not be 1:1. Make this an opportunity to learn more about clinical trial process (metformin or others) and appreciate how difficult it is and see what you could bring to the process, be it money, patient record, tumor sample or joining it.
http://clinicaltrials.gov/ct2/show/NCT01101438?term=metformin+breast+cancer&rank=6
Best wishes
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Wildrumara, I got a prescription from my PCP too.
I have insulin resistance, and was pretty much diabetic until I lost some weight. Even then and sticking to low carb, my glucose levels were up there. They have already pretty much proven that if you are like me, metformin is a good drug to take to decrease recurrance risk. So I'm taking it. Currently not taking an AI, so this is my conventional drug of choice.
If you have normal blood sugar, well they aren't sure if it helps. That's what they are trying to determine. I would hope that if it does make a real difference they will start giving the real med to everyone.
Starting out with just half a 500mg pill per day, will go to a whole one very soon. Pretty sensitive to meds, wanted to see what would happen. So far I'm constipated! Always said I had the opposite reaction than the usual to meds.
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Just a quick FYI. It has shown promise in other cancers as well. Particularly, prostate, liver and pancreas. Good to know that something as deadly as liver and pancreatic cancer may be helped with this benign drug. My family doctor has a pancreatic cancer patient that is going on three years with the use of metformin. It is currently his only treatment. Quite outstanding results for such a deadly cancer.
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@jenrio - I truly want to help and participate in a clinical trial, and I would NEVER join if I decide to take the drug. Cancer has taken too many of my family members and I know the importance of trials. That is why I am so torn?? Although I do not carry the BRCA gene, there is definitely a familial component to the cancer diagnoses in my family, (breast, pancreas, colon, prostate and that's just my mom's siblings). I am the youngest ever to be diagnosed at 42 though. Anyway, I am going to think about it for a few more days.......thanks for the info!!
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Wildrumara,
I just hope everyone will be comfortable with whatever commitment made. This is not the only metformin trials available. There are also other clinical trials available for other promising agents.
Though it's the biggest and the most likely to generate statistically significant data. If they accrue patients quickly, interim data would be available sooner than 5 years, and if the data is clean and metformin proven very effective early on, I suspect they will let patients cross over or end the trial early or patients on randomized arm could drop out. This kind of trial is a lot of work and rather thankless, big risk for the researcher's career and everyone lose if it fails (due to slow accruals, on-trial patients dropping out or taking metformin off the record hence polluting data) to produce good data.
The difficult choices you have to make is a clear illustration of the difficulty of running clinical trials like this. If the drug is promising+cheap, patients don't want to join clinical trials for good reason. If the drug is not highly promising, patients don't want to join clinical trials for good reason. If the drug is promising+expensive, patients want to join clinical trials. No wonder the drugs that we end up with, that's even half effective, are all very expensive drugs.
http://www.nytimes.com/2009/08/03/health/research/03trials.html?_r=2&ref=health
This 2009 article goes over the problems with trial recruiting. Only 3% adult cancer patients go into clinical trial. It also goes over why some trials are designed to fail, and trials cost oncologist income sometimes. It also mentions ispy-2 trials (Dr Laura Esserman) as a potential solution for this problem.
Best wishes for your staying recurrence free. Since you seem to have some genetic risk, maybe you should seriously consider a full-genome sequencing or join other studies even if this one doesn't work out.
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Good luck, wild.
I am happy to have this option and if nothing else my glucose levels are now normal/lowish and I have virtually no SEs.
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