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

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jenrio
jenrio Member Posts: 558
edited June 2014 in Just Diagnosed

Huge Phase III clinical trial:

http://clinicaltrials.gov/ct2/show/NCT01275677?term=her2-low&rank=1 

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

    Thanks Jenrio for posting this here!!!!  Need to get the word out about this clinical trial.

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  • wildrumara
    wildrumara Member Posts: 450
    edited April 2012

    Hi ladies -  I am trying to find out information regarding this trial.  I'm not real adept at finding information on those clinical trial pages...so much information.  Anyway,  My IHC came back equivocal at 2+, but my FISH was negative.  Not sure if I would be a candidate or not??  I had neoadjvuant TC x 6 and then surgery, with 2 positive nodes despite having chemo first.  At any rate, I will try to find the information on the NSABP or NCI pages......just thought maybe you could clarify.  Does FISH have to be positive also???  Becuase I had neoadjuvant would I not be a candidate for this??  I also have a friend in a similar situation, although she is triple negative.  She did not have a great response to neo-adjuvant chemo either, so I'm thinking this might be something for her to consider....??? 

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

    Wildrumara - I am in the clinical trial and have been randomized to receive the Herceptin along with my chemo (Taxotere/Cytoxan- 6 rounds every 3 weeks) starting next Tuesday.  I am low HER2 +1 which translates to negative in the Herceptin world.  Under the standard treatment protocal, I would not be receiving the Herceptin but for this clinical trial.  If this clinical trial is successful, Herceptin may become a part of the treatment for low HER2 +1 's. 

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

    Wildrumara- Try this website link to get more info about this clinical trial.

    http://www.clinicaltrials.gov/ct2/show/study/NCT01275677

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited April 2012

    Melrose...I read the clinical trial details and just want to clarify that if Herceptin is found to benefit the "low" Her2 +1 and +2 in THIS study, it still does NOT include ALL Her2 +1 and +2 patients.  Instead, it specifically is looking at patients with the following tumor characteristics:

    All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met:

    • By pathologic evaluation, primary tumor must be pT1-3

    • By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b

      • If pN0, one of the following criteria must be met:

        • pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative
        • pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of ≥ 25
        • pT3 regardless of hormone-receptor status, histologic grade, and Oncotype DX® Recurrence Score

     ________________________________________________________________________

    So, patients like myself with Grade 1 Stage 1, T1 tumors with Oncotype DX scores below 25 BUT who have Her2 +1 or +2 pathologies, would NOT qualify for the clinical trial.  Furthermore, if the results DO indicate that the patients in the sample benefit, then the question would remain would patients at lower risk, like myself benefit as well?  In any case, it should be interesting to see where the results of this trial lead.  It also is refreshing to see that they are conducting this type of trial.  I applaud all of our sisters who participate in this trial.  I'd be remiss if I didn't applaud the courageous sisters who participate in ALL clinical trials.  I wish ALL our sisters well.

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

    My only comment is that this clinical trial may be a starting point to determine who benefits from Herceptin besides those who now receive Herceptin as a part of their treatment plans.  It is my understanding from my onco's research coordinator that prior clinical trial data was reviewed and determined that some of the participants were not true positive HER2 but were in fact low HER2 +1's and may have benefitted from receiving Herceptin in the prior clinical trial.  I don't know what prior clinical trial she was referring to or a participant's qualifications to be that clinical trial.  Not everyone who qualifies for this clinical trial is willing to be followed medically for the next 10 years. 

    Who knows, hopefully one day there will be a drug that looks for another characteristic of breast cancer that can be used to effectively treat true negative HER2's just as  Herceptin is now being used.   

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  • volley44
    volley44 Member Posts: 11
    edited November 2012

    I have been asked to consider my participation in this study. My stats are 50 years old, 3cm IDC, ER+/PR+, HER2- (+1), micromet in one snl, and grade 3. Had blm October 22 with immediate reconstruction and will start AC the week after Thanksgiving. Two drains out and 100cc fill last week and then last 2 drains out on Wednesday.

    This whole experince has been like Alice down the rabbit hole. Such a temendouns number of decisions from surgery to treatments. It's so overwhelming.

    Is there something wrong by thinking what's one more treatment if it might help? I don't know.....just feeling under water right now.

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  • Beesie
    Beesie Member Posts: 12,240
    edited November 2012

    Very interesting.  I think it's great that Herceptin might be able to benefit more women, and I applaud everyone who is participating in this trial.

    VR, interesting too about the participation criteria. Herceptin has shown itself to be a very effective drug, but it is also a very serious drug, with serious risks.  So it makes perfect sense that at this time they are looking to extend the usage of Herceptin to women who have been diagnosed with high risk, aggressive cancers. If Herceptin works for these women, it can save many lives, and the benefits from the drug could certainly outweigh the risks of taking the drug. But for someone who faces a lower risk of recurrence and mets from her BC diagnosis, even if Herceptin can provide some reduction in risk, it might not provide enough benefit to outweigh the risks from the drug itself. To this point, it is interesting to note that the trial has two different Herceptin arms, testing different dosing of Herceptin. 

    It will great if Herceptin is found to work on these other breast cancers. Perhaps then they will consider testing Herceptin with less aggressive cancers. If they do, I am sure that they will look at quite a different treatment protocol, reducing the amount of Herceptin that the patient gets.  The approach might be more similar to the clinical trial underway with Herceptin for DCIS patients who are HER2+.  The patients in the Herceptin arm receive two infusions of Herceptin over their 6 weeks of radiation. A previous trial of HER2+ DCIS patients had the patients receive just a single dose of Herceptin, prior to surgery.  This trial is completed; some raw data is available but final results have not yet been published. 

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited November 2012

    Beesie.. Very interesting! Any idea when they might publish their preliminary findings?? I don't know about you, but I am getting very excited about the upcoming annual December San Antonio Breast Cancer Symposium.

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

    volley44- I am currently participating in the B-47 Herceptin Clinical trial and one of those who is receiving the Herceptin.  If you opt to participate, your MO will input your info into the study.  At that time, you will be randomized to determine if you receive the Herceptin or not.  There is no placebo in this clinical trial--- one either receives it or does not receive it.  Deciding whether to participate in a clinical trial is a very personal choice and one only you can make.  Please feel free to contact me if you have questions.  Wishing you the best of luck wih your chemo!!!

    Beesie & Voraciousreader- Always glad to see your posts on the threads!!!!

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