Are you currently (or have you been) in a Clinical Trial?
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Susan and EV11, It looks like Dr Rugo is the primary investigator for the Morpheus Trial for ER+ breast cancer. One potential problem is that you can be randomized to faslodex alone in Stage 1 of the trial. Here's the UCSF link:
https://clinicaltrials.ucsf.edu/trial/NCT03280563
Theresa
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Hi Susan,
I was on talazoparib (PARP inhibitor trial) for 10 months. Both Olaparib and Talazoparib (TBB trial) are being tested as monotherapies in triple negative breast cancer and cancers with BRACA-like (associated with DNA-repair) genetic or somatic mutations. They are both approved for BRACA1/2 mutated breast cancers. My CHEK2 and FANCA genetic mutations qualified me for the trial. PARP inhibitors are generally well-tolerarted (easier than Ibrance or Xeloda for me). The main side effect was lowish blood counts, but I never had to dose reduce or hold treatment. I'm not as familiar with the combination PARP inhibitor trials... maybe they have found a way to make ER+ breast cancers without DNA-repair defects respond to PARP inhibitors.
The LBBC Metastatic Breast Cancer Conference was held in Philadelphia this last weekend. Dr Vasan, an MSK oncologist and breast cancer researcher, gave an excellent summary of trials and treatment options in ER+ breast cancer. The first half is a bit of review, but in the second half he talks about trials and new treatments. You can watch it here:
https://clinicaltrials.ucsf.edu/trial/NCT03280563
You're wise to educate yourself about potential treatment options, but I'm very hopeful that Dr Rugo will already have a plan for you. I'm very curious to hear her recommendation.
Best Wishes,
Theresa
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Susan, I see you just passed your 5 year mark with MBC. Congrats!!!
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Thanks JFL!!! So sweet of you to notice! I was very excited to reach that mark and still have be active, pain-free and able to find non-iV treatments.
When I was first diagnosed Stage IV, I sold my term life insurance to a company that was willing to pay me 67 cents on the dollar that I would not make it for five years. Got the money upfront and while I'm still alive to enjoy it. They ended up with nothing. Was looking over my shoulder until the maturity of that policy lapsed but now I can relax. ;-)
Hugs, Susan
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Looks like my next treatment will be the oral taxane, DHP 107, trial. It is randomized so I have a 33% chance of being put on conventional IV paclitaxel.
wildplaces, you win the prize for your suggestion!
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Susan, best of luck in your trial and WOO HOO for how you handled your life insurance!!! I'm impressed!!!
Katty
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Only one more sleep, as my GD used to say, until I get to find out if a clinical trial is in my near future. I'll keep you updated.
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Susan - Thanks for letting us know about your next treatment. Oral chemo would definitely be my preference over IV chemo. I'm glad that you have access to the DHP 107 trial. The oral taxane has been in trials since 2008 in various cancers, so oncologists know how to dose it properly and they know that it has better "systemic bioavailability" than IV paclitaxel. I was hoping that Dr Rugo would suggest a hormonal or targeted treatment, but I have every confidence that she is selecting the best treatment for you at this time. I'll be praying that the oral taxane is highly effective against your cancer with minimal side effects.
Hugs and very best wishes! Theresa
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Thanks for letting us know of your next treatment, Susan! I hope you get into the oral taxane arm of the trial. It seems like the side effect profile is less pronounced than ivy taxol from what I've read. Keep us posted on your progress. Wish you all the luck and a great run on this trial!
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Hey, y'all! Here is a fun fact for the Alisertib group. A recent paper indicates that this drug has a beneficial effect on the immune system, and this may play in to why some of the phase 1 trial participants are getting a long time on this drug. I can't access the paper from here, will have to read it at work, but here is the abstract:
The Aurora-A inhibitor alisertib shows encouraging activities in clinical trials against advanced breast cancer. However, it remains unclear whether and how the inflammatory microenvironment is involved in its efficacy. Here we demonstrated that inhibition of Aurora-A directly reshaped the immune microenvironment through removal of tumor-promoting myeloid cells and enrichment of anti-cancer T lymphocytes, which established a tumor-suppressive microenvironment and significantly contributed to the regression of murine mammary tumors. Mechanistically, alisertib treatment triggered apoptosis in myeloid-derived suppressor cells (MDSC) and macrophages, resulting in their elimination from tumors. Furthermore, alisertib treatment disrupted the immunosuppressive functions of MDSC by inhibiting Stat3-mediated ROS production. These alterations led to significant increases of active CD8+ and CD4+ T lymphocytes, which efficiently inhibited the proliferation of tumor cells. Intriguingly, alisertib combined with PD-L1 blockade showed synergistic efficacy in the treatment of mammary tumors. These results detail the effects of Aurora-A inhibition on the immune microenvironment and provide a novel chemo-immunotherapy strategy for advanced breast cancers.
So be happy in knowing that while the drug is holding the cancer at bay, it is also enabling your immune system to get in there and kill off some cancer cells!! The longer you go, the more the tumor burden is reduced- awesome!! And of course these new results may push some pharma to do a trial combining it with immunotherapy..
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Wishing you the best results and options today, Grannax!
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Thanks, Katty
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Great info on Alisertib Cure-ious! Thanks
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Cure-ious- sounds very intriguing!
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Based on our personal experience, I would suggest getting on these exciting trials(such as alisertib) when you are doing well. Most of these trials have stringent requirements such as HgB levels, Total bilirubin and the prior number of chemotherapies (usually two). When there is progression, it happens really fast and 21 day wash-out period(where you get no treatment) can kick you out of the trial, especially if you have liver mets. It would also make sense to try promising experimental therapies when you are asymptomatic and your back is not against the wall. I realize this is not the commonly preferred or recommended approach...
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Cureious- Thanks for thegreat info, as always!
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Bornfighter,
Your advice is great. But, I know of two trials that don't want to hear from me until I am failing a protocol. I don't understand that.
Jennifer
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Is the Alisetib trial the one going on at Mayo? Based on bornfighters response someone with liver mets wouldn't be eligible. My family member with liver mets and now two chemos... I want her to be eligible but the washout period is scary. But the trial sounds so hopeful.
Here is something. My family member... we have an autoimmune illness, vascalitis, in our family ... it took an immediate family member's life, so would that make her more likely for an autoimmune flare in something like this? A beneficial flare? I understand this is all about mutation and genetic testing... I'm wondering if immediate-family-member having a severe autoimmune disease would be actually beneficial..or bad..would it make it more likely she would have an autoimmune response to something like Alistib?
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ChuckL - the Alisertib trial is at Mayo in Rochester Mn and other sites. Below is the link to the specific trial information if you don’t already have it. I was accepted into the trial - with bone and liver mets. Sorry can’t answer to autoimmune inclusion or exclusion -
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Bornfighter,
I'm sorry how that worked out, but clearly if the situation is urgent,they want to make sure the patient gets onto some established chemo regimen given that all of this is experimental. You raise a critical point, most of us are not aware of all of the restrictions getting into a trial (for example, most require measurable disease, and therefore are not options for bone-only disease; and on the other end many say no more than two chemo treatments in the metastatic setting). Others seem to be open to all comers, with the exception that brain mets have to be stable there has to be a certain level of liver function. It seems we are only able to access a couple of trials at most, so its best not to wait too long to jump in if you see something you want. Hopefully those with really great results will get rushed through. For example with Ibrance, the results were so great that once the phase 2 trial was completed and the phase 3 trial was fully enrolled, the FDA went ahead and approved the treatment for everybody.
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Jennifer, your question about having to wait to get on a trial? That’s because it’s considered unethical to take you off a standard treatment that is working. I’m waiting to fail my Havalen so I can join a phase one trial. Phase Ones are very accepting and don’t have all the restrictions phase 2 and 3s have. I’ve had too much treatment for most phase 2s. Phase ones are not cancer specific but can offerr unique approaches not otherwise available when no standard treatments are left.
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Some trials require you to have been on a minimum number of treatments so it is all very complicated. My trial coordinator said that being on a taxane will open up more trials to me because some require that you have already had a taxane. I have also seen trials that require 3 or more previous chemo treatments. The Alpelisib trial I was on was only open to those who had failed on a CDK4/6 but had no more than 2 previous treatments. The bottom line is we have to look ahead when making any treatment decisions. Some qualifications are out of our control, like having brain mets, but the timing of our treatment choices is something we can sometimes manage.
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The trials definitely seem to be at one end of the spectrum - early in treatment history . . . . or late when no other approved therapy is available. The trial I am in is a Phase 2 of the latter type. However, at any point in treatment, a patient can determine they do not want to take any more approved treatments and that would be enough to qualify for the latter. The trials don't follow up on the other end to confirm whether you resume approved treatments once your time in the trial comes to an end.
I had strategized that the best way to address the washout period, in an ideal world, is to time the trial to start after you stop a (more powerful) treatment that is not administered as frequently. I had the plan of timing a trial after Abraxane (I was on an every 3-week dose) or Doxil (every 4 week dose) so that there really would only be a short or no true treatment holiday. By the time I would be ready for the next treatment, I would be eligible for the trial. That didn't work out with all the moving parts involved but I did at least time my current trial that required a 4-week washout at the time I had the 2-week recovery period from Halaven so I essentially only had a 2-week period of not being treated. I didn't start Halaven until I enrolled in the trial and was waiting for the paperwork to go through. The trial permitted me to be on interim treatment after I had a required biopsy and submitted my application until the final trial basket approval, which then required a 4-week washout. I applied in early December 2018 and was not accepted until mid-February 2019. And that was with me riding the doctors and research team heavily the entire time to make sure they were pushing everything with Foundation One and the NCI as much as they could and making special calls to try to have each step expedited.
The whole process is really sad at the end of the day. We are essentially just a number and it is a strange feeling when the MO's primary focus goes from what is best for you as the patient to what is required of trial participants for trial compliance purposes, regardless of whether it is detrimental to you. It fundamentally goes against the Hyppocratic Oath taken by doctors (First, do no harm). However, we have no better solution at this point.
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ChuckL,
As Ann1999 mentioned, having liver mets is OK for Alisertib trials. They just have a bilirubin requirement. If it were based on previous week's blood results, we would have made it. Actually, Alisertib trial is more accepting than many other trials. Also the team at Mayo is awesome and very helpful. They have a 21 day wash-out period but other places require 14 days.
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My new MO decided to use Xeloda 3500 a day for 2 weeks and off one week. My PET looked pretty bad in my lung chest and liver. She'll rescan in 2 months.
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I just saw that the FGFR inhibitor, erdafitinib, I am taking was FDA approved a few days ago for urothelial cancer. It is called Balversa and will cost $10-$22K per 28-day supply. Super expensive!
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My biggest fear right now is that I will have some secondary condition needing a treatment or medication that could get me thrown out of my immunotherapy trial, so of course, that's what has cropped up. Last week, I started getting a sore spot under my chin that has gotten progressively worse and swollen - very painful to the touch. My lymph nodes are not swollen, I'm not running a fever, and my blood work the day before this started was great. I'm not having any issues swallowing, but that may not be true by tomorrow. I woke up every couple of hours last night because of discomfort.
Two weeks ago I had four days of soreness under my tongue, lower gum aches and swollen glands. I went to my oral surgeon because I thought this might be related to my ONJ - osteonecrosis of the jaw - that I've been dealing with since February, but he said my mouth looked good, healing was progressing etc. and the issues cleared up on their own. Weird.
I have restrictions about what I can take and procedures that are allowed on my clinical trial, so I'm thinking I should go the the MD Anderson ER today, so I will be in the same system and can coordinate with my clinical studies team while they determine what is happening - blocked salivary gland, maybe? There are so many moving parts, otherwise I would just go to a doc in the box or free-standing ER today.
Does this sound reasonable? I am normally a real under-reactor who waits too long to get treated for things, so I'm trying to look out for myself, while feeling a little silly considering going to the MDA ER since this isn't life-threatening.
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I'm back from Memorial Sloane Kettering. I saw Dr. Shanu Modi, and the "team" on Thursday, 4/18/19.
As it turns out, the initial screening is an invitation to more screening. People can have enough mesothelin in their blood sample to indicate mesothelin over-expression, but is it enough? What they really want to see is if the tumor itself is producing enough mesothelin. Someone with high blood levels might not have just quite enough in/on/around the tumor.
To that end, they need stained and unstained slides of a soft tissue met to do their analysis of it. Bone mets can't play, as they are hard to sample, the cells get deformed, and - on the whole - just aren't a reliable indicator.
Luckily, I recently had a liver biopsy for a Foundation One assay, and when they were taking the samples, I asked them to take as much as they could, not just as much as was needed just for this test. That was thanks to this forum, where I had read of too many people not having enough tissue for this or that test. So the interventional radiologist/surgeon took a bunch of tissue. He was in there so long, I thought he dropped his keys in my liver. MSK should have the tissue by early next week.
If I truly qualify, then it is off to cell collection day. That's the leukapheresis, where they remove my blood from one arm, spin it in a machine to get the T-cells needed, and return the remainder back into my other arm. However, I have had a mastectomy and lymph node dissection and so they can't use my right arm for anything due to lymphedema fears. They also can't use my Bard Power Port, as it is too small and will deform the cells (that again!).
So I will need another procedure to access an artery near my clavicle - and that's when I started hearing white noise and my brain shut off. It's a procedure they do all the time with the interventional radiologist, no one has ever died of it, and I can't participate in the trial if I don't agree to it. So there. I'll do it. After the cell collection procedure, they will remove it.
During the cell collection, I'll be pretty pinned down by machinery, so the nurses recommended that I make my peace with a bedpan or absorbent underwear. I will have been told to really hydrate a week before the process, so peeing will be an issue.
Also, the cell collection blows through calcium, so the nurses want me to eat a lot of calcium-rich foods the week beforehand.
After about 4 hours, the cell collection should be done. They send me back to Interventional Radiology to remove the catheters (white noise again). I'll lie about being observed for a few hours, then I'll be sent back to wherever I came from, as long as it is less than two hours away from MSK. For me, that will mean another night at the hotel, where I will take a night to rest up, then hop on a bus to get home the next day. It's an express bus, so it goes straight from MSK to my stop. Spouse will be with me, but will have to stay to work, then drive off to go fetch a certain college kid who can't come home on the bus because he has too much stuff.
Six weeks pass. They make my T-cells into serious mesothelin ninja cells. They give me a call, and I head back there for the magic infusion. Two or three days before the infusion they will give me a dose dense chemo that will prepare my marrow for new, better, improved T-cells. Then they will put in about a tablespoon full of the secret sauce, and I'll be in hospital for 2 to 3 days to be observed for the period that has the most possibility of trouble. Then, I will be dismissed, and must stay within two hours of MSK with someone to watch over me 24/7 in case of side effects. And, the side effects can be serious: immune over-reaction, loss of speech, neurotoxic reactions, little stuff like that. Now, those were mainly seen in the earlier trials with the liquid cancer folk, but they haven't completely disappeared yet. Dr. Modi says that no one has ever died in one of her trials, but they are still going to be Very Careful.
During those six weeks, I'll be seen by the trial folk two or three times a week. Hopefully, the social workers at MSK will have hooked me up with housing at the Hope Lodge (free!) for me, and whatever lucky relative will be my caretaker that week. Spouse will be around as much as he can, but Hope Lodge only offers housing for the patient and one caregiver, so if a relative has signed up for a week he is NYC, he will use worker housing, which kicks everyone out for the week-end.
If we end up with other housing plans, more people will be able to stay around in NYC. Apart from Hope Lodge, everything is looking like at least $125 a night. That's cheap for NYC, I know, and we do have our own personal "Trial Fund" we've been saving for, but my complaint about trials is the cost of transport and housing, which is normally totally provided by the patient. It can add up.
After those six weeks, it's back home, where my local MO will observe me. I'll be making a once-a-month trip to MSK for the first year for check-ins. I praise the express bus. I can even hitch a ride with spouse if it coincides with an NYC visit for him.
All digits crossed my tumor makes the right amount of mesothelin. If not, I'll start putting into plan the next trial I'm looking at. There's not many for ER/PR+, HER2- metastatic breast cancer patients who have been heavily pre-treated. Sadness.
Jennifer
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wow Jen. I'll keep my fingers crossed for you. Are you on anything in the meantime? Or are you on chemo break?
Sunset
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Jennifer, thanks for the play-by-play. This sounds quite similar to the trial that Judy did in many respects although I know hers was different (and if I recall correctly, you already pursued that one). Does this trial require a washout period?
Katty, I hope you can get to the bottom of what is going on in your mouth and that it turns out to be something that will not cause an issue with the trial. Good it is not ONJ. Is there any chance it is a funky immune reaction to the trial medication?
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