Faslodex trial for Stages 2 & 3. Anyone else participating?

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wjminva
wjminva Member Posts: 5
edited May 2015 in Clinical Trials, Research News, Podcasts, and Study Results

I was diagnosed in December with Stage 2A ILC. Thanks to wise advice to meet with an oncologist as well as a surgeon, I'm now participating in a clinical trial known as ALTERNATE (Alliance A0lll06), an acronym for Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment in Postmenopausal Women: A Phase III Trial (whew!).

There are three arms to the study during which (simplified explanation) participants receive either Arimidex (anastrozole), Faslodex (fulvestrant) or both drugs for six months prior to surgery, with regular oversight and testing to assess how the drugs are affecting the tumor. I am about to begin my fifth treatment cycle and am scheduled for surgery July 1.

Because Faslodex has been used to treat only late-stage breast cancer, there isn't much (if any) data about potential side effects for women like me who have early-stage disease and for whom this is the first treatment. I'm eager to connect with others who may be participating to share experiences and compare notes.



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  • Hopeful82014
    Hopeful82014 Member Posts: 3,480
    edited May 2015

    I was offered the opportunity to participate in a similar trial, however, it was Femara or Femara w/Faslodex. I chose to 'shadow' the trial using Femara only. So far the results have been quite good. Surgery and SNB are Wednesday and I am very eager to get the pathology results, particularly for the node.

    I hope the trial works out well for you, wjinva, and will look forward to hearing more about it.

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  • wjminva
    wjminva Member Posts: 5
    edited May 2015

    Dear Hopeful - Thanks so much for your response. I'm sorry I didn't see it before your surgery, and I too am hopeful that all went well for you. If you choose to share, I'd love to hear.

    I'm doing very well on the faslodex trial. My tumor has shrunk considerably (to more than half its original size), and yesterday the oncologist was unable to palpate it at all. My surgery is scheduled for July 1. The only concern: hair loss. But if that's the price, I'll pay it.

    All the best as you go forward.

    Regards,

    wjinva

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  • JohnSmith
    JohnSmith Member Posts: 651
    edited May 2015

    wjinva. This is an interesting trial. Thanks for posting.
    Any chance you can add your biopsy pathology details to your profile? (i.e. tumor size, Ki67 percentage, etc -
    I assume you're ER/PR+, HER2- and low Ki67).

    For those that are interested, here's the details of this trial from clinicaltrials.gov.
    - Estimated Enrollment: 2820
    - Study Start Date: December 2013
    - Estimated Primary Completion Date: April 2016
    - 138 Study locations throughout the U.S.

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  • wjminva
    wjminva Member Posts: 5
    edited May 2015

    My apologies, JohnSmith. I wasn't aware that my settings had blocked my additional profile info. I've now made it public.

    Unfortunately, the tumor-size drop-down menu only offers a range of 2 - 2.9 cm and it posts as 2 cm. My tumor size was closer to 2.9. The only item I could not see to add was the Ki67 score. At dx, it was <1% -- a very good sign. FYI - there were two trial-required biopsies: one prior to start and one at 4 wks. The first biopsy results were not shared with the doctor. However, at both the 4-week and optional 12-week biopsy (which I had), there was insufficient tumor to get a Ki67 score. My hope/guess is that this was due to the size of the mass (which continues to shrink) vs physician error.

    Here is the direct link to information about this sstudy on clinicaltrials.org: https://clinicaltrials.gov/ct2/show/NCT01953588?term=Fulvestrant&rank=65



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