NSABP B-47 Herceptin for HER2-Low Invasive Breast Cancer

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dltnhm
dltnhm Member Posts: 873
edited June 2014 in Clinical Trials, Research News, Podcasts, and Study Results

Is anyone participating in this trial? My oncologist explained it to me today and believes that I am an excellent candidate. If I am chosen and if I actually receive the Herceptin (Trastuzumab) then it might be possible that the Herceptin might have an effect on my cancer.

In the meantime, since the rest of the contents of the regimen are a standard chemotherapy treatment:

Adriamycin (doxorubidin)

Cytoxan (cyclophosphamide)

followed by Taxol (paclitaxel)

the only change would be that the Paclitaxel would be given once a week for 12 weeks following the 4 cycles of AC in order to mirror the Herceptin regimen (which is once a week for 12 weeks too).

And then the Herceptin would continue for a year once every three weeks at the end of the 12 weeks.

The side effects of the Herceptin are pretty scary to read ... but I have to remind myself that when I read the side effects of so many prescription and over the counter meds there is lots of scary stuff there too if I delve into it. And yet I still take many of them when I need them.

Just wondering if anyone is doing this or knows of anyone doing it. Or any thoughts or comments.

Thanks in advance!

Diana

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  • marinakaplan
    marinakaplan Member Posts: 23
    edited January 2012

    I joined this trial - I have one more AC left then the 3 week break then I start with the Taxol and herceptin, I was really happy that I got into the treatment arm, there are no FDA approved targeted therpies for me because I'm triple negative, so I'm hopeful about herceptin.

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  • dltnhm
    dltnhm Member Posts: 873
    edited January 2012

    Hi and thanks for responding. It sounds as if you know that you will receive the Herceptin. Hopeful for you as you are almost at that stage.  I won't know for a bit if I have made it into the trial. Had a bone scan and CT scan on Friday too.  I'll meet with my oncologist to discuss those results and going forward. Let's keep in touch!   Diana

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  • dltnhm
    dltnhm Member Posts: 873
    edited February 2012

    Just wondering if anyone else out there on the boards is taking part in this study?

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  • bak94
    bak94 Member Posts: 1,846
    edited February 2012

    I am not part of the study but my mo had mentioned putting me on herceptin.I am trip neg, I think my her2 was +1. I have had ac twice and having rads on my left side so I was concerned about the side effects. Have there been any preliminary studies you know of that have said herceptin benefits low her2 pos? I am done with chemo so I wouldn't be able to get into a study. I would seriously consider it if I was able to qualify. I think I read somewhere that  her2 neg may respond to herceptin, but I don't remember where I read it, and my mo seems to think that also. I would love more info on this!

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  • exbrnxgrl
    exbrnxgrl Member Posts: 12,424
    edited February 2012

    I was offered this trial. My first mo really pushed it. Before I could start, I had agreed to participate, my single bone met was discovered. My mo seemed less interested in me at that point. I now have a new mo and am doing very well. Kaiser Permanente is a big participant in this trial. It's purpose is to see if women who are HER2 - but with some low HER2 receptivity can benefit from Herceptin.

    Caryn

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  • BaseballFan
    BaseballFan Member Posts: 859
    edited February 2012

    Does anyone know what phase this trial is in?

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  • exbrnxgrl
    exbrnxgrl Member Posts: 12,424
    edited February 2012

    Phase III

    Caryn

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  • dltnhm
    dltnhm Member Posts: 873
    edited February 2012

    Getting closer. My first chemo is Wednesday. I will be officially put "on study" tomorrow (Monday).



    Once put on trial, I'll actually find out if I am in the control group or not. So I'll see what Monday and Tuesday brings.



    On a side note, the nurse coordinator for this study is pushy, hyper, and nosy. That does not sit well with me so I am going to address my concerns with my MO and my chemo nurse, both of whom I love. Something has to give with this other gal however because I refuse to have her intimately involved with my life at all. She is on a need to know basis for what is relevant to the study and I have read and digested the study protocols numerous times so I know when she is just meddling.



    Ah well. That's my little mini rant for the evening!

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  • dltnhm
    dltnhm Member Posts: 873
    edited February 2012

    Control. Time to digest this new news.

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  • JennL
    JennL Member Posts: 78
    edited March 2012

    Hi I am in this study, will find out Monday if I take Herceptin or not. My HER 2 score was 2+. I will be doing AC-T for my chemotherapy. I figure I'll do whatever I can to keep this from coming back!! Good luck to everyone!

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited April 2012

    Hi

    I have volunteered for this study.  Still have some preliminary tests before I know for sure that I am eligible to participate (bone scan, CT scan, echocardiogram, labs).  My HER2 score was +1 which is considered HER2 negative. My chemo regimen will be Taxotere & Cytoxan-- 6 rounds every 4 weeks.   Once I know what is what, I'll be back to update.  Positive, calming & healing prayers, thoughts and energy to all!!!!!

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  • jenrio
    jenrio Member Posts: 558
    edited April 2012

    This is a huge phase III study, they want to recruit 3000 patients over 100+ locations (which tells me phase II study probably had a very good result).     If Herceptin is found to benefit some subtype of Her2- patients, it can improve prognosis for a lot of currently Her2- patients including TN girls.    Everyone newly dxed (before chemotherapy) should double check their Her2 IHC test results (1+, 2+) and consider this clinical trial.    If she is randomized to the standard arm, she gets the standard chemotherapy, so no loss.   

    Following is a paper that I found:

     http://www.nejm.org/doi/full/10.1056/NEJMc0801440

    Jen  

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited April 2012

    Bump to keep newbies aware of this clinical trial!!!!

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited April 2012

    I just heard from the oncologist after the randomization for the study--- I will be receiving Herceptin with my chemo next week!!!!.  Ready to make my contribution to breast cancer research!!!!!!

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  • jenrio
    jenrio Member Posts: 558
    edited April 2012

    Congrats to Melrose!

     When I got DXed, I had no idea these trials are going on.   This clinical trial should be reposted to newly diagnosed forum because that's when the patients may qualify for this trial.

    I've read papers that only 2%-5% of BC patients do clinical trials. Lots of studies can't get patient accruals. Childhood cancer used to be a big killer, butin America, we have the system of all pediatric cancer patients go through clinical trials. Now pediatric cancer has 90% cure rate. If 100% of advanced stage patients go through clinical trials, then maybe BC would be cured faster.

    Could someone repost this clinical trial to stage IV? stage IV would be most interested in this.

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited May 2012

    bump

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  • CityFi
    CityFi Member Posts: 95
    edited May 2012

    So thankful I found this board! I was just invited to participate in this trial this week. I have so many questions and conflicting feelings. Please, ladies, come back and talk to me. I've got a big decision to make!

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  • jenrio
    jenrio Member Posts: 558
    edited May 2012

    Hey, what are you trying to decide on?   G L!

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  • dltnhm
    dltnhm Member Posts: 873
    edited May 2012

    CityFi,

    I am participating in this trial. I actually started the thread so you can read what my treatment plan was/is at the top.

    I was put into the control arm so I am not receiving Herceptin. I received that news before I started treatment, so I knew it going forward and also knew that my treatment was standard except for the 12 weekly doses of Taxol rather than 4 DD of Taxol which is what many patients receive.Lately I have been struggling with feeling that I am not receiving everything that I could receive to fight this cancer if I'd been put in the trial arm and would be receiving the Herceptin also. But that is the hand that I was dealt and am not regretting my decision to join the trial.

    I am thankful that I am receiving the Taxol over 12 weeks. From anecdotal evidence on the boards there appears to be much greater incidence of side effects when the Taxol is given 4xs DD. This is also reported in some studies. Also, there was a study published in 2008 which had close to 5,000 participants showing that Taxol given weekly improved overall survivability and disease-free survivability. 

    Given what I have learned I would also choose Taxol over Taxotere. Although they are both taxanes, the reported side effects with Taxotere seem to be much harsher.

    For me, participating and beginning in this trial was not a difficult decision. The chemo treatment of AC/T is standard for my diagnosis. Having the benefit of additional screening before the trial had begun, close monitoring during the trial, and monitoring after for years afterward were all plusses in making the decision. Also, one has the option of withdrawing from the study at any time. During those first 8 weeks when I was receiving AC, I learned more and more about Taxol and the implications of taking it over 12 weeks. That sealed the deal for me for staying in the study. 

    I'm here if you have any other questions.

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited May 2012
    dltnhm- Glad to hear someone else is in the study.  I talked to my onco's research coordinator today about how many participants there are right now---- over 700 women which is about 24% of the number of participants the clinical trial would like to have.  I just had my 2nd round of chemo this past Tuesday and receiving the Herceptin.   Thanks for starting the thread and hope more find out about this clinical trial.
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  • ashley2
    ashley2 Member Posts: 62
    edited May 2012

    I am also in this trial, with herceptine. I'm done with 3 AC, another AC next week,  next 12xT and herceptine. no big problems with AC, just neutropenia .........big enough to delay the treatement twice....

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  • CityFi
    CityFi Member Posts: 95
    edited May 2012

    dltnhm, thank you for sharing that. You actually clarified something for me because I was told that my treatment protocol was going to change shortly before I was asked to consider the trial. Not expecting this, I didn't take notes or record the meeting (something I ordinarily do) because I thought it was going to be what we had been discussing all along, and the appointment was two days before I was supposed to start chemo. That said, I got all the drugs confused! I had some question as to what would change or not.  It seems that there is an additional benefit to joining the study even if I'm in the control arm i.e. taking Taxol over the 12 weeks. Something else to consider. 

    I just sent the investigators my questions. Two pages worth! I'm leaning towards participating and no one answer will make or break my decision, but I don't want to commit and then quit over something minor that could've been foreseen before e.g. insurance matters.  I have an EKG scheduled for the 29th, and my guess is that they would like for me to have a decision by then so I can sign the consent and do anything else on that same day and get going. 

    By any chance, are any of you in the study in any group taking supplements?  Did you before the trial? If so, did they request that you stop?  Being able to continue with my supplements would be a huge plus for me. After all, they're asking me to take an additional drug for another year with all the risks with no guaranteed benefit; I would hope I can take some steps towards safeguarding myself from some of the side effects if possible. 

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited May 2012

    CitiFi-I am not taking any supplements currently.  However, I did submit a list of supplements that I may want to take to my onco for her approval prior to my starting chemo.  She did approve all of the ones I was considering to take.

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  • CityFi
    CityFi Member Posts: 95
    edited May 2012

    Melrose, which ones were you considering if you don't mind sharing. 

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited May 2012

    B-complex 50, Acetyl L-Carnitine, L-glutamine, Vitamin D3, Biotine, Lysine, B6, chia seeds, flax seeds

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  • CityFi
    CityFi Member Posts: 95
    edited May 2012

    Thanks, melrose!  I'm still on the fence about the trial.  The nurse just sent me a report based on what they do know about Her-low women and Herceptin.  I'm also reading the "biography" of Herceptin called HER-2. It's a fascinating read... just like a novel.  Apparently, the story was also a Lifetime movie starring Harry Connick, Jr. ;-) 

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  • Melrosemelrose
    Melrosemelrose Member Posts: 3,018
    edited May 2012

    CityFi- Glad to hear from you!!!  Just remember you can opt out of the clinical trial at any time for any reason.  When is your chemo start date?

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  • CityFi
    CityFi Member Posts: 95
    edited June 2012

    Hey, Ladies!  With my doctor's blessing, I'll begin chemotherapy after a speaking engagement on the 22nd.  I still haven't made a decision about the clinical trial yet. Interestingly, I met a woman yesterday at a new member meeting for Gilda's Club and when I mentioned the trial, she said that she had stomach cancer, was getting Herceptin despite being HER2- and her tumors were shrinking. I've gotten all my questions answered, read all I can, etc. and feel the time has come to allow intuition to guide me.  I can tell you that very few people in my inner circle want me to do it, despite my telling them that the decision is far more complicated than not allowing myself, to paraphrase the different ways I've heard it, to be used as a guinea pig for shits and giggles to benefit some drug company. I'm just trying to get to the place where, if I enroll in the trial, I'll be at peace with whichever arm I land in. Whether or not I get Herceptin or not, I want to feel that I made the right choice. 

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  • cookiegal
    cookiegal Member Posts: 3,296
    edited June 2012

    Cheers to all of you taking part in this important study!

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  • jenrio
    jenrio Member Posts: 558
    edited June 2012

    If Herceptin is proven working for Her2-low IDC (even early stage), then it might open up a whole new possiblity of treating Her2-low IDC with TDM-1, Pertumasub, other conjugate/antibody therapy.

    It opens up possiblity of treating Her2-low advanced IDC with some kind of debulking surgery or other chemotherapy.   This clinical trial is very important for advancement of Her2-low treatment.

    I'm reading a very good book "Emperor of all illness", ie, cancer.   It tells the story of Herceptin's invention.   One of the inventor had a pack rat mentality so collected lots of patient's tumor samples.   One of the samples has very high level of Her2.   So he called and especially invited this patient into Herceptin's clinical trial.   But the patient has already given up and refused.   Only when the researcher insisted did the patient join.

    This patient has a large visible tumor (in addition to many insible ones), and checking on its visible shrinking under herceptin became the ritual of the entire cohort.   Some of these brave pioneering patients died, but this lady survived.

    So don't expect magic, but give it a chance.

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