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Are you currently (or have you been) in a Clinical Trial?

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  • susaninsf
    susaninsf Member Posts: 1,099

    Nicole,

    I'm not a doctor but I think that Trodelvy alone is a fantastic drug. Really no need to do it with Keytruda as that could introduce other complications/SEs. Being on a trial also usually involves a wash-out period. Also, you can take Keytruda with a Taxol without being on a trial. I took Keytruda with Abraxane.

    Hugs, Susan

  • nicolerod
    nicolerod Member Posts: 2,877

    Thanks Susan..yes my MO already offered Taxol and Key... Abranxane has a shortage and I cannot get it..no one can unless they are already on it. Right now...I am just down..bc I didn't the results of my scan from today my MO was suppose to call.... and the IR in Washington DC already read it for the liver (her assistant told me) and now she is out tomorrow so I am not gonna have any results till Monday now :(

  • husband11
    husband11 Member Posts: 1,287

    Oh Nicole, that is terrible. I know we are on pins and needles the whole time waiting for results, but now to have to add on 3 more days. That is so unfair.

  • Kattysmith
    Kattysmith Member Posts: 688

    Nicole that is so frustrating to have to wait for results. I'm so sorry they are putting you through this. I hope that you can put your worries into a box, close it up tight, and shove it under the bed until Monday, so you can have a good weekend. xoxo

  • susaninsf
    susaninsf Member Posts: 1,099

    Nicole,

    I don't know if this is a California law but we now get our scan reports automatically at the same time as our doctors.

    Hopefully, someone will call you today.

    Hugs, Susan

  • BevJen
    BevJen Member Posts: 2,341

    Susan,

    I believe that is federal law now. Reports are to be released at the same time to the clinician and the patient. However, from reading BCO, it sounds like not all facilities are doing this. I think this is because there are no penalties yet for clinicians who don't do this since regulations have not yet been established.

    Probably worth it to ask your doctor for those inquiring minds who want to know. I get my stuff really quickly now, and it's a mixed blessing!

  • cure-ious
    cure-ious Member Posts: 2,854

    Whoo-Hoo, y'all... Abstracts for SABCS have been posted!!

    https://www.sabcs.org/Portals/SABCS2016/2021%20SAB...


  • husband11
    husband11 Member Posts: 1,287

    Cure-ious, is there an index for those pages?

  • nicolerod
    nicolerod Member Posts: 2,877

    I posted my results in LIVER THREAD for all that were asking... love you all.

    *** CURE...i know you don't frequent liver thread but if you could have a look at my post I would be grateful for your insights...

  • cure-ious
    cure-ious Member Posts: 2,854

    Husband, I don't know about an index, but you can just search the page for keywords you are interested in, it searches all of the abstracts for you...

    I just did that for ARV-471 (Dee's drug, the super ER-degrader), here is the summary of that trial (cutoff date was last June), looking good!! These are patients who progressed on Ibrance-Femara/Faslodex and were allowed up to 3 prior chemos..

    "As of the data cutoff date, 6 of the 34 patients were continuing to receive study treatment, including 2 patients who had been on treatment for over 16 months. Two confirmed partial responses were observed among the 28 patients with baseline measurable disease and at least 1 on-treatment tumor assessment."

    Conclusion: ARV-471 was well tolerated with no Dose Limiting Toxicity at total daily doses up to 700mg. ARV-471 demonstrated robust ER degradation in paired biopsy samples and encouraging clinical activity (41% CBR) in patients who received prior CDK 4/6 inhibitors.

    ARV-471 is now being evaluated in the VERITAC Phase 2 monotherapy expansion at 200 mg and 500 mg once daily.

  • susaninsf
    susaninsf Member Posts: 1,099

    Thanks, Cure-ious,

    When I looked through the original agenda, it seemed like the only drug relevant to us was Samuraciclib, an oral CDK7 inhibitor. Reading the abstract starting on page 47, there were only 23 patients on the trial and the results were not spectacular.

    Hugs, Susan

  • cure-ious
    cure-ious Member Posts: 2,854

    Hi Susan! Actually I was kinda blown away this year (only read thru the first hundred abstracts) of all of the updated reporting and how many trials are advancing, this to me seems WAY better than the last several years for SABCS. And remember, the ones that are most impressive will have been embargoed for press releases when the talks are given in December.

    Regarding Samuraciclib, the CDK7 inhibitor, tested with fulvestrant on people who progressed from I-F, my first impressions on reading that were : 1) great news that there were few side effects, there were rumors for couple of years of bad SEs, so that's not true; 2) decent response in the trial, given how early it is and few patients tested, they aren't scaled yet for efficacy; 3) I agree with you, though, that these numbers do not rock your world the way some of the SERDs and ER degraders seem like they will be getting. If I were progressing on I-F, I would not want to go try a CDK7i with fulvestrant, I'd head over to the world of SERDs, ARV-471, etc., get better control on the endocrine part and then contemplate what to combine it with.

    Imagine you have progressed from I-F to a SERD-CDK4,6 and then progressed again, yet the cancer still seems to be ER-dependent? You'd want other options- like combine the SERD with everolimus, or a CDK2 inhibitor, or a CDK7 inhibitor, go for something the cancer has not seen before. We need options for those who have run the course with CDK4,6i, but are still endocrine-dependent.

  • susaninsf
    susaninsf Member Posts: 1,099

    Cure-ious,

    Yes. I find this frustrating too. I have taken both Ibrance and Verzenio. Ibrance worked for almost two years. Verzenio, less than six months. Seems like most of the trials involve Ibrance plus whatever drug they are trialing. This way their numbers look great since Ibrance is such an effective drug on its own. We need more options for ER+ folks since we go through treatments relatively quickly, unlike HER2+ people who can stay on Herceptin and Perjeta for 10+ years. We keep saying, "Where are the FDA-approved oral SERDS?". Checked the Arvinas (ARV-471) site and they do not do any Early Access Programs.

    Hugs, Susan

  • [Deleted User]
    [Deleted User] Member Posts: 760

    Just signed the papers and start my new trial on Nov 29, on AC682 a new serd.

    I will be the very first person. Since I am doing pretty well, I decided to be a trailblazer and trust my trial doc. I hope I get some traction out if this one and push the chemos out to the future.

    I will keep you in the loop. My trial will be opening in other places eventually. Total of 42 patients.

    Dee

    One interesting potential side effect is sun sensitivity - sunscree, hats & sun glasses recommended. Glad I am starting in the winter


  • moissy
    moissy Member Posts: 371

    Dee -Great to hear that you got in! Thanks for forging ahead, which helps all of us. Wishing you the best!

  • moth
    moth Member Posts: 3,293

    mTNBC near City of Hope - Phase 1 trial just opened for an oncolytic virus. Pts must have progressed on standard therapy

    https://www.onclive.com/view/city-of-hope-opens-on...

    https://clinicaltrials.gov/ct2/show/NCT05081492?te...


  • susaninsf
    susaninsf Member Posts: 1,099

    I have my slot on the ARX-788 trial at USC but still have to do screening (CTs, EKGs, etc.). The main downside of the trial is there is a 28 day washout period. According to the trial page on clinicaltrials.gov, it was a 14-day washout but they have since doubled it. I wonder why. That is a long time to be off treatments. My MO wants me to do one more cycle of eribulin since I seem to be doing well on it. This means I won't be able to get the trial drug until the end of the year.

    Pretty disappointed.

    - Susan

  • cure-ious
    cure-ious Member Posts: 2,854

    Susan, Congratulations on the trial slot!!! the drug looks superb, too bad for the long washout but then again, the rest of the body gets to recover a bit...

  • [Deleted User]
    [Deleted User] Member Posts: 760

    Susan,

    Congrats on getting a slot!!I they can be very competitive.

    my trial had a 28 day washout. It's pretty common. Too bad they changed yours. Waiting while not in treatment is the worst! My trial team at SCRI worked miracles and got my start date on day 29 from washout. I agreed to an extra visit to get all the pre testing done. I had a scan yesterday so I should now on Monday how much I progressed from Nov 1.

    Dee

  • susaninsf
    susaninsf Member Posts: 1,099

    AlabamaDee,

    Will be thinking of you tomorrow and sending positive energy your way.

    Hugs, Susan

  • emac877
    emac877 Member Posts: 688

    I had a question for you all, at what point did you decide to opt to go in to a trial? Forgive me if this question has been answered somewhere and I missed it. I found the thread looking for info on the SERENA trials. Several of you are familiar to me from other threads. I am learning a lot just reading through here. I am not currently in a trial and am stable on my current therapy. I am just an information hound and like to know my options in advance should things progress. Thanks.

  • [Deleted User]
    [Deleted User] Member Posts: 760

    I found this trial listing for anyone willing to go to MDACC for a trial. If only other cancer centers would produce and post these lists! I know they would need updated regularly, but what a help it would be to the local MO and us patients

    https://www.mdanderson.org/documents/Departments-and-Divisions/Breast-Medical-Oncology/ABC-Clinic-Trials.pdf

    Dee

    Posting my scan results on the liver thread

  • perky2020
    perky2020 Member Posts: 76

    emac877 that is a great question! I asked my MO and my secondary MO and they both said for me next they would recommend Xeloda which is a chemo. Then I hear many trials do not allow patience that have had chemo and that we should do a trial before we are heavily treated?

  • [Deleted User]
    [Deleted User] Member Posts: 760

    perky 2020 & emac877

    It is true that many MBC trials do not allow multiple lines of chemo. Some allow only 1, many allow 2 and a few allow 3.

    In my experience, if the disease is not in a visceral crisis mode or growing very very fast, then targeted or hormonal therapy trials may offer a chance to push more chemo down the road. I chose to go to a trial when my 4th line of SOC failed. My first trial failed, my second gave me 11 months (better than any SOC) and I start my 3rd on Monday.

    Getting access to the latest research drug sometimes years before it becomes SOC was my great motivator when 4 lines failed. I think it depends on the type of breast cancer and what trials are being offered. My cancer is ER+ and ESR1 mutation which is a challenge the new trials are targeting. I could not get into the 4 big SERD trials that are racing to get FDA approved, but I did get into the newer ones.

    The standard of care lines of treatment is changing for MBC. image

    Dee

  • moissy
    moissy Member Posts: 371

    Wow, Dee, that trial list is so well compiled andhelpful! Thanks for posting.

  • GG27
    GG27 Member Posts: 1,308

    My MO suggested that instead of standard of care, I might want to look at a trial for a new drug, Ibrance. I would never have had the opportunity to be on Ibrance if I hadn't gone on the trial. I got 30 cycles out of it. When it was finally approved, approval was for first line only, which here in BC, I believe it still is 7 years later. I am now on my fourth drug trial, fifth or sixth lifestyle trial. I am happy to extend the number of lines I have open to me, even if some of the trial drugs are not a good fit for me.

    cheers, dee

  • susaninsf
    susaninsf Member Posts: 1,099

    Wow Dee! 30 cycles is amazing! I was also on an Ibrance trial and got 20 months (27 or 28 cycles) on it. It was just a dosage trial, 100 vs. 125 mgs so very low risk.

    I've been on three trials so far, Ibrance, Piqray and Trodelvy. All are now FDA approved. Hope my luck will continue on the ARX-788 trial I'm trying to join.

    Hugs, Susan

  • susaninsf
    susaninsf Member Posts: 1,099

    Found three other sessions at SABC that might be interesting those of us who are ER+/HER2- or low, Elacestrant and Opdivo+Yervoy on Wednesday and Neratinib+Herceptin+Faslodex on Thursday.

  • BevJen
    BevJen Member Posts: 2,341

    Susan,

    I think that second one is the Summit basket trial that Shetland pony was on.

  • cure-ious
    cure-ious Member Posts: 2,854

    Good catch, Susan!! Time to work in some trials in that have immunotherapy (IO) as well. Dee, for your list, it seems that if I-F worked for any reasonable time, we should head to trials for SERDs or PROTACS well before trying Xeloda. And for anything with immunotherapy, it should include some compound designed to expose the tumor by releasing immunosuppressive cells.

    And we need better biomarkers too- PDL1 expression, for example, is a very poor predictor of who does or does not respond to IO...