Clinical Trial E5103

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear KFinnigan,

    I just noticed that you are ER/PR+. Will you be getting hormonal therapy also?

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  • michellehb
    michellehb Member Posts: 35
    edited October 2009

    Went in for my 7th Avastin/Placebo today and was given as normal, no special consent required. Discussed with PA who said temporary enrollment stoppage when an item needs furher info is not uncommon. I have MUGA next week due to minor abnormality in last one. Her advice was to go by my particulars, and make decision after this MUGA.

    Had to laugh about cactus butt. I've had similar issues. Must check out the Proctofoam HC.

    Curious02 - I have also had issues with low WBC. For several weeks, same thing. Counts would drop, I'd get fevers, landed me in ER twice. Last hospital visit the working theory was diverticulitis, which prevented me from getting my 3rd Taxol. And yes, study doesn't have you making up, unless it's an Avastin/placebo week. But I am now taking 3 neupogen shots a week, and voila, no more neutopenia or fevers. I was never mentioned this would not be allowed on study. Maybe something to look further into.

    May also drop down 20% cause my numb feet are getting worse, and I lost balance once this week. It is what it is. I hate the thought, but have also to think about permanent SE's. Lastly, I have a friend who bailed study after AC, due to SE, and they were able to find out she was on the study drug.

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  • michellehb
    michellehb Member Posts: 35
    edited October 2009

    unklexwifonty - know your question wasn't directed at me, but am also ER+/PR+, and will be getting tamoxofen. Can't get rads though. Had too much as kid for hodgkins lymphoma, so looking for all the amo I can get within reason. Living through what too much amo can cause.

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  • tamlyn110
    tamlyn110 Member Posts: 195
    edited October 2009

    I started chemo (AC)  on 9/16 with the Avastin/placebo. I am getting Ac every 3 weeks x4 then Taxol 12x weekly. My blood pressure did go up a little bit and I have been having some of the butt issues and of course the naseua. I went in on Wednesday for my bloodwork and my WBC was too low they said but it is too late this time to get a neulasta shot. They said I am now considered high risk though so I will get the shot after chemo from now on. I am a little nervous about the Avastin but for now I feel I am being watched close for side effects so I am going to stick it out for now.

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    I wonder why the study does not have you making up the doses you have to miss due to side effects. That's not how the doctors treat off trial so why should they do this on trial? Annoying to say the least. It almost seems like they want you to go off trial if you have to delay treatment so that they can improve their results. One more example of the BS from big pharma.

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  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    Hi girls!  Happy Saturday!  yes I've gone thru the whole stinkin trial!  haha

    Onty, I am on Tamoxifen, started after Taxol and right before Rads, the onc wanted me starting it right away and the rad onc wasn't sure so he spoke to my clinical trials nurse, they know each other...there were no restrictions with the trial so I started it.  5 year plan for the Tamox.  Doing ok with it, mile 'warm/hot flashes', No MOJO! and neck stiffness and I've been seeing a physical therapist for low back/hip pain since starting.  He thinks the pain is from loss of muscle during tx, so we are trying to strengthen my tummy muscles and loosen up the tight hips.  These treatments all do a number on our bodies!  But I exercise each day and try and eat good.  Doing what I can!!

    Hugs to all you beauties!!

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Kari,

    Yes these treatments can do a number on the body. That's why we have to take care of it ourselves. Good to know that you exercise and eat good every day.

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    This may be a strange question but here goes. At my first chemo, the nurse asked me to sign some papers. Among them was a sheet that looked like it came from Roche/Genentech - it had their logo on top. The sheet had sections VI and VII but no previous sections and it looked like the last page of a longer document. When I asked the chemo nurse for the other pages she indicated that this is all she had. She did not give me a copy either. Anyone else know what I am talking of? It was not the main consent document for the trial, which was about 25 pages and I had to initial each page of that document.

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  • moborn63
    moborn63 Member Posts: 70
    edited October 2009

    Had a dr apt this week and My doctor spoke to me about the trial. He told me that The trial was suspended based on a pre-planned cardio-toxicity analysis of the first 200 patients enrolled in the trial. The protocol for the trial specifies that enrollment be suspended if six or more cases of clinical congestive heart failure. and at least 6 woman out of the first 200 developed congestive heart failure. No deaths have been reported but further enrollment has halted. But if you are currently in the trial you can continue. I chose to continue. They had me sign a paper giving my concent.

    Hope this info helps

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Robin,

    Thanks for the update. That is consistent with what the news reports said.

    How often are you getting your heart checked thru MUGA, thru EKG and thru' BP? 

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  • moborn63
    moborn63 Member Posts: 70
    edited October 2009

    I received a Muga about 6 weeks ago and I am schedule to receive another in Nov

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    That sounds like once every 4 doses of Avastin which is per the study protocol. I feel nervous with that frequency...... you don't?

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  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    Keep all your MUGA scores, I have them on a post it at work.  I kept my blood counts also handy, so I could compare as I went.  My MUGA score went down during chemo then back up some and upon my last one (I think the 5th) after my final Avastin my number went down again to the lowest at 51 (normal is above 50)...it really freaked me out.  But it was done in a new building on a new machine.  I wrote my onc but she said not to worry...easy for her to say...

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Kari,

    My baseline MUGA was 59. If it drops to 53 or so, I am stopping Avastin.....

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  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    mine was 58 to start...I will post all my scores tomorrow when at work!! Have a great day

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Thanks Kari.....

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  • curious02
    curious02 Member Posts: 13
    edited October 2009

    That is intresting about the trail. I mean the part where maybe they wanted me off the trial because of my wbc. I wished all went smoothly but I would of been crushed if I had to reduce my taxol and Avastin and found out I was on placebo. I have to tell you my spirits where lifted on Friday because I was getting all the taxol and could make up the two I missed. My hubby had to give me the wbc shots at home and I feel like I have a bad hang over but the alternative is no treatment. I did a breast cancer walk this morning in my home town and there where 10,000. people who walked, it was very emotional for me!! We need a cure!!

    Cathy

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Cathy,

    Are you getting Neupogen with Taxol also? I imagine that is after getting off the study because the study protocol says you will not need (meaning "get"!) Neupogen with Taxol.

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  • curious02
    curious02 Member Posts: 13
    edited October 2009

    I am getting the shots at home. Had my third today. I will try to find out on Friday if or when I will be un blinded.

    Cathy

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Thanks for the info Cathy. I will clarify with my oncologist why E 5103 does not allow Neupogen when on weekly Taxol. It is one thing that they won't pay for it but they should allow you to get it if needed and let your insurance should pick up the tab.....

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  • cjw
    cjw Member Posts: 42
    edited October 2009

    Hey michelehb----

    I finished the avastin in May (I am in chgo as well) and I definitely experienced the wbc dropping during the Taxol part of the treatment. I also had numbness in my foot--it went away after the taxol finished.  You could basically be me--tumor stuff is all almost exactly the same.

    I am just checking back b/cause i got a letter on suspending the study. Thanks to brena and all the originals for keeping us all informed.

    carol

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Carol,

    New enrollment  is suspended. The study is not suspended. Just want to be sure that those looking for information on this trial don't mis-interpret the "suspension"....

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  • tamlyn110
    tamlyn110 Member Posts: 195
    edited October 2009

    Went to onc. office today to have bloodwork before my chemo tommorrow and they called me in to talk to the dr. He told me about the trial being suspended to new patients but he said he wanted me off if it so I agreed especially since my blood pressure just keeps going up & up everytime I go there. Today it was 164/106. I would have really liked the added benefit but with being on Adriamycin(spelling?) which already can cause heart problems, it is just to risky for me right now.

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Tamlyn,

    I am so glad you and your doctor chose to get you off the trial. BP of 164/106 is way too high to risk it. No one knows that there is any added survival benefit from Avastin in early BC. You made the right choice. I wish you a speedy completion of the rest of your treatment and quick relief in your BP. FWIW, my onco mentioned that at the doses given for BC, the risk of heart disease from Adriamycin is <1%. You may want to ask your doctor too.

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  • tamlyn110
    tamlyn110 Member Posts: 195
    edited October 2009

    Thanks Onty,

      You made me feel better.  I will have to ask Onc about about the adriamycin. I am not on the DD version. He made it seem like it was alot more to worry about as far as heart se's than <1%. Good luck with your treatment.

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    You are welcome Dear Tamlyn. Do let us know what your onco says.... maybe mine was pulling a fast one on me :)

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  • curious02
    curious02 Member Posts: 13
    edited October 2009

    Carol,

    Did they adjust your taxol or Avastin amount? How did you keep your counts up? Did you have to put on hold any treatments? Were you on the long arm or short arm of the trial? So many questions! sorry.

    Cathy

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  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    Just wanted to say good morning to all!  Reading this thread everyday and keeping my eye on all of you!  haha!!  Have a great day and gentle treatments!

    Big Hugs! 

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited October 2009

    Hi Everyone....just checking in....

    Well Next month I will of completed my treatment one year ago! Its hard to believe its been a whole year.  I wasn't aware that the trial had been suspended but when I go in next month Ill talk to my onc about it.  My ejection fraction never changed during my treatment and I had a lot of Avastin. 

    I finished my reconstruction but Im looking at having another surgery because Im not too happy with the "girls"  and because my PS doesn't think he can do much about it Im going to have to go to a new PS.  Im not too happy about this.

    So have any of you decided on the cruise in May???? 

    Brena I hope your trip is wonderful.  I went to vegas a couple of weeks ago, about 25 of us from this site met there and had the time of our lives! so much fun, looks like we will be doing it each year!  Last week I took my granddaughter to Disney world, sea world and spent some time at the beach...a beautiful place called Anna Maria Island (south of tampa). 

    Carolyn, I hope your doing well.  I really hope the three of us can meet up on the cruise next year.  I hate that I missed the oppurtunity to meet you guys during the last one. 

    Well I wish us all a very healthy fall and winter, before we know it the new year will be here!

    Teresa

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  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Teresa,

    So nice to hear from a veteran!

    Be well.

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