Are you currently (or have you been) in a Clinical Trial?
Comments
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Thanks JFL! How are you doing?
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Hi Susan- Is it for pain or to help immunotherapy (or maybe both?) Your MO said its OK?
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Susan SF- sounds promising! Can’t wait to hear your results.
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Hopefully both! Really doing it to boost the immunotherapy but if it helps my Plantar Fasciitis that'll be icing on the cake.
Don't know if it's any indication but my Neutrophils on Friday were up much higher than usual. Usually, I barely scrape by if I haven't done a Zarxio shot.
A little diarrhea this afternoon but otherwise feeling fine.
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I started Day 1, Cycle 2 of the SERD/Palbo trial yesterday.
Remarkably, my ANC was up to 2.6 after only 6 days off palbo, and my platelets had recovered to 165K, up from 112K last week and 20K higher than they were when I started the trial. I have known bone marrow mets and I am hoping that these good blood numbers indicate the drugs are working on the cancer in the marrow...unfortunately I am not having MRIs to follow response on the trial, so there is no definitive imaging to show improvement there or not...will have to deduce impact based on lab results.
CT scan on Dec 9 will give information about the bladder tumor, ascites and mental stranding, though. Am waiting for the results of my CA27-29 and CA125 to post tonight or tomorrow morning....
I hope everyone--but especially those of you on trials-- are having good results and minimal side effects; and I wish most sincerely that everyone is well and happy.
Elizabeth
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I'm re-posting a note I left for the Moderators on a thread where they asked who is going to the San Antonio Breast Cancer Symposium this year, where they will have a meet-up.
Here is my comment:Not me!!! It is a disgrace that SABCS 2019 have decided to not make their abstracts available to the public until they are way out of date next February (2020). Most of this research is paid for by tax dollars, and the data itself derives directly from those of us willing to participate in the clinical trials, yet we are the last to read about the advances (or lack thereof). So the patients, whose lives and hopes depend on this information more than anyone, are no longer to be allowed access online a month in advance,as was the case for the previous decades. The SABCS already embargo abstracts they consider "newsworthy", but now they have decided that none of it will be made available to us to evaluate it for ourselves in advance of the conference. Truly a horrible decision for patients.0 -
And now, for happier news. A report in the latest Cell identifies a new biomarker signature of triple-negative breast cancers that much better predicts whether or not they will respond to immunotherapy.
They were able to create a mouse model of TNBC that was altered to contain a high tumor mutation burden and respond well to immunotherapy. As was also reported recently in Nature for response to CAR-T therapies, one of their findings is that it is important to get B cells involved in the response, to stimulate the T cell activity overall. The race is on to find a vaccine or some other way to goose these B cells, and hopefully get immunotherapy working for the rest of us. Progress!0 -
Cure-ious, do you know or can you guess the reasoning for not releasing the abstracts?
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Cure-ious,
I couldn't get the second link to load -- does that article contain more about the response to immunotherapy? As you know, I've very interested in this even though I'm not triple negative -- I do, however, have a high tumor mutational burden (25 mutations) including the errb2 mutation (did I get that one right? I always transpose the letters in that mutation.) So I'm truly interested in what's going on in the world of immunotherapy.
Going to a one day conference tomorrow in Baltimore re Immunotherapy and will report back if they say anything new or startling. I think it will be very basic (which is good for me, a nonscientist) but happy to share anything new that I learn.
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Here is the Cell paper:
https://reader.elsevier.com/reader/sd/pii/S0092867...
And yet another report discussing the implications:
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Sandi- Sometimes its just an organizing committee, deciding it makes the meeting more exciting if only the (paid) participants can get direct access to the new findings, or wanting to control (even more) the news coming out of the meeting. Control, arrogance, the Metastatic Breast Cancer Industrial Complex...
(edited to get the facts straight)
You have to watch these guys- ASCO 2018 embargoed an abstract about a PI3K drug (Taselisib) meaning the results would only be available in a press conference, which of course is normally reserved for the best news- when they finally release to us the great news saying that the trial was a big success for a new class of drug, it turns out the results in the abstract just stink on ice, like the trial only showed a month improved PFS compared to placebo!! Then the SAME DAY as this "happy news" is spreading around the press, the drug maker quietly announces they will not be pursuing the drug or requesting FDA approval (obviously based on the crappy result of the trial). Later on the lead investigator for that trial, Dr. J. Baselga (Memorial Sloan Kettering), quits his position because he apparently does not like to comply with the publication requirements for disclosures of his links to industry, and now he works for AstraZeneka. While he could well be a fine doctor who is just non-compliant about rules and regs, it shows how important it is to have direct access to the actual data, not just hear the spin and then read the facts months later.
So the upshot is that we should not assume that even major conferences have committees that can necessarily pick a good abstract from an awful one, or might play games to help industry hide their bad results from the public, who knows? Also, they will not necessarily highlight news we are most interested in. But with this new change from SABCS to deny us access to the abstracts in advance of their meeting looks like either they want to control what comes out in the press, or want to make sure that we pay them for access, or both.
Fortunately, the science journals are becoming a lot faster in how quickly major articles are published. Meetings like SABCS have abstract deadlines months in advance (last summer was their deadline), and while the oral presentations are up-to-date, they may not be ahead of the whole story coming out in print. And of course the meeting may not have anyone presenting the big stories that were just published. So we are better off with following the science literature...
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Cure-ious, I can't speak to the politics of the medical research community but do know that from a securities law standpoint that the reason notable news comes out in a press release first is that securities laws require that of publicly traded companies. A company cannot selectively disclose material nonpublic information that may impact the stock price. Sadly, the only population of non-medical professionals that may follow clinical trial results more closely and on a more granular level than we do are shareholders and investors of the drug companies as well as the analysts covering the companies' financial results and forecasts. I have found myself listening in on company earnings calls to obtain news about a drug approval before it is published in medical literature. The analysis is very detailed on these calls. That being said, hopefully this means there is in fact some notable news. Positive at that. The whole taselisib thing was so weird how it was handled with respect to quietly disclosing that it is no longer pursuing the drug right after the "positive" news about the trial came out.
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I went to a great program today sponsored by the Cancer Research Institute. If anyone is interested in immunotherapy trials, or wants to find out more about it, go to their website at https://www.cancerresearch.org
The program is billed as a Patient Summit, and they've already got two of them set up for 2020 (info on their website.). It was highly informative, plus there was a lot of opportunity for Q and A both of patients and of practitioners.
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JFL- Excellent points- I am surprised because "my type of research" does not entail for-profit companies and patient trials and press at this level, so I am used to conferences that are a lot more open. But once you bring in the money and the shareholders, and concern about pharma stock prices and all these MDs, then obviously it becomes a different world!!!
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Hi everyone,
Well I started then crashed out of a phase 1 clinical trial for a CDK7 inhibitor last month. After a couple of weeks I started to experience shortness of breath and quite a bit of pain shoulder/neck/shoulder blade pain. And my legs blew up. I ended up being diagnosed with a pulmonary embolism & blood clots, then needed to have a pericardial effusion drained, and then developed a pleural effusion (a diuretic worked). Stayed 6 days in hospital and I'm still not 100%.
So now I'm waiting to start paclitaxel. Since I have been traveling to Toronto for the trial. the transition to local care has not been as smooth as one might like.
I've spent the last 4 years avoiding paclitaxel by doing clinical trials (I really didn't like it back in 2005) but I guess the time has come.
SusaninSF - I'm glad that you checked back in and that you're on a new treatment. EV11 - I was interested in your trial too...but my energy to keep traveling for trials is now greatly diminished. Sadly, I think starting this 2nd chemotherapy will close a lot of trials for me. But I don't really have time to wash out either. I'm nervous enough that I'm on nothing right now.
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NewGardener- Sorry that CDK7 wasn't the right drug at the right time, but I don't think having had chemo #2 will be too restrictive for future clinical trials- and hopefully its going to be a long time before you need to look at another one! Despite the recent problems, it seems that you are doing extremely well for someone with mets for nine years!?!!
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NewGardener, wow, it sounds like you have been through quite a bit- what terrible side effects. Please tell us how you do with the next phase with paclitaxel! We continue to route for you!!!
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Hi All,
I didn't realize this thread was here. I am on a trial for H3B-6545 (estrogen receptor antagonist) and posted a separate thread: https://community.breastcancer.org/forum/8/topics/874216.
I don't know yet if it is working, but the side effects are very minimal.
I would love to know if anyone else is on this trial.
Thanks.
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Welcome, Mika!!
Many of us will be following your experience closely, please feel free to post here anytime!
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Hi All,
I met with my MO today and we have arranged to have the blood tests done to work out if I have the BRACA mutation in my tumor gene to quality me for the ENHANCE trial in Australia. It is a phase II trial using lynparza (olarparib) parp inhibitor. Has anyone had any experience with or knowledge of this drug?
Many thanks in advance.
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NewGardener,
I was on paclitaxel but the premeds, steroids and benadryl, made me miserable. Switched to nab-paclitaxel (Abraxane), that doesn't have premeds because of the delivery mechanism. Have been fine ever since. Just want you to know that there are other Taxol options including Taxane, if the regular Taxol is intolerable.
Hugs, Susan
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Thanks Susan. My first infusion is this afternoon. And I was just worrying about the steriods...remembering how 15 years ago I was, maybe, a little irritable from them. Fingers crossed that the weekly dosing will be better. But I'll keep the Abraxane option in mind.
Heather
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This is cross-posted elsewhere, so please forgive any redundancy...
I am two weeks into cycle two of the SAR439859 (oral SERD) trial--I am on the SERD plus palbo arm.
Let me tell everyone that this is the EASIEST, most TOLERABLE regimen I have been on to date. Way easier than Ibrance/Letrozole, in that I have none of the AI-associated joint-aches side effects. This SERD has minimal s/e for me (slightly dry eyes, a bit of constipation); and I am tolerating 125mg palbo better than I was the 75mg when I was on it for three plus years during 2015-2018 (although I am only two cycles in, but if it get rough I can dose reduce the palbo.)
My platelets have recovered to 200K+, my ANC is 1.76 on day 15, and my WBC is 3.4...RBCs are a bit lower than I'd like at 3.3, but not concerning. All other labs are completely normal. My AST and ALT have gotten progressively better every week while on this trial (I had developed a slight hepatitis from the IO trial I was on over the summer....this regimen is not interfering with liver healing at all.)
My first on-trial CT scan is at the end of cycle 2--Friday Dec 6. I'll get results on Monday Dec. 9 and learn if I can stay on the trial. That would be lovely Christmas present! If not I'm thinking about enrolling in a new HER2 low phase 1 trial at my local cancer center. (It would be VERY nice to to not have to drive 7+ hours round trip weekly to Seattle, although if this SERD is working I'll happily keep doing that, especially since it drops to every-other-week for the duration of the trial starting in cycle 3.)
I hope all of you are doing well, getting a good response from your treatment, and looking forward with a light heart to the winter holidays. May you all be blessed with happiness, good health and the love of family and friends.
Elizabeth
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Elizabeth,
So happy that this trial is going well for you! It is great that you have limited side effects, and that you are feeling well. Fingers crossed that this continues!
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Elizabeth,
I'm happy your trial is going well for you too. Hoping it works for a long time. The SERD sounds promising.
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EV11,
that is the trial i've been waiting to go on, it's been on hold for some reason since May at my cancer centre. i'm told it's oral faslodex with or without ibrance. but if you're on the none ibrance arm and you have progression they then put you on ibrance even if you've been on it previously. I will be watching to see how it goes for you.
best of luck, cheers, dee
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Way to go EV11.
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Thanks for the update Ev11.Fingers crossed for your pet scan.
Hugs,
Ann
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Hi Elizabeth (EV11) so very pleased to hear that you are tolerating the oral SERD trial so well and managing 125mg Palbo. How you do on this combo is of great interest to me and I am sure many others considering the “what next”. It is really wonderful that you feel so much better than you did when you took Letrozole. Everything crossed for Friday 6th and please let us know your results on the 9th. Thinking of you and hoping you are enjoying Thanksgiving. xx0 -
Elizabeth,
Fantastic news for you and for all of us! Thanks for letting us know. Always looking for that next treatment.
Hope you can be on this for a long time!
Hugs, Susanj
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