Are you currently (or have you been) in a Clinical Trial?
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Nicole, so good to see you smile!:) Saulius
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Ok friends...so I literally am HORRIBLE at trying to understand these trials and the inclusions and results etc. I have even read the thread on here that helps with it and I still STINK at it. I just had The CRI Cancer Res. Institute send me 2 trials they are saying I am a match for.... I was wondering if anyone can tell me if they even have heard of these...if they are good/bad....etc? One of them I believe it requires and ONCO test score of MORE than 25 I was 49.....
NCT02693535 0 -
Nicole,
The first one is TAPUR, which your doc should be participating in. It's a multisite ASCO trial. My doc is on their "safety monitoring team" but Hopkins is not participating. They are testing certain drugs. I called about that one bc there was an arm that had nivolimumab and ipi, two immunotherapy drugs, but that arm has been "discontinued." But if you call the contact on that one and tell them your MO's name, they should be able to find out if you're eligible for it.
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Nicole,
The second one, from what the description says, is Stage IIb? It's also up in Philly. Maybe CRI has incorrect info for you? Again, I'd contact the trial person listed in the report and see what she has to say, if you are interested in going up to Philly for treatment.
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Thanks bev I KNEW I WASN"T wrong about that 2nd one. I emailed the lady back this morning and told her that wasn't for ppl with Metastatic disease and she said i was wrong?!?! I edited the post and removed that one. Also that first one is at my cancer center...I just didn't know if anyone knew anything about those....
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Cross posting with clinical trials:
I just realized that someone else on this thread other than Nicole might want to find out about the TAPUR study. Here is the description of it:
The TAPUR Study is a clinical trial for people with later-stage cancer, focused on whether specific targeted therapies can benefit more patients and lead to more personalized therapies.
And here is the writeup on cancer.net for more information:
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about why immunotherapy does not work well in breast cancer...
. They figured out why but Lord knows it will probably take 10 years before they have something that will fix it.....0 -
After 9 months, I'm off the DESTINY04 trial of Enhertu for HER2 low. I had two liver mets and some other spots grow. I've been doing the all-consuming progression followed by search for a next treatment dance. After an exhaustive search for trials that didn't pan out, we decided to try Trodelvy off-label (I'm ER+/PR+). It has a different target (TROP2) than Enhertu which targets HER2, but the two agents deliver chemotherapies that are similar. If my cancer has developed resistance to the chemo, then it is unlikely to help. Apparently TROP2 is common in all breast cancer types, so it could help get more chemo to the cancer. The other choice was Halaven which will likely be my next treatment. I've had two microwave ablations of liver mets in the last year which I believe have helped, but my interventional radiologist does not believe that we can keep using microwave ablation. She said that Y90 is an option, but she said that my institution does not do it until at least 25% of the liver is involved since healthy liver tissue is also affected with Y90. For those of you who have gone the Y90 route, have you heard this?
Prayers and high hopes for all of us!
Theresa
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theresa45, we're really sorry that you are now off the DESTINY04 trial, but sounds like they are presenting some good treatment options for you. You may want to jump over to this thread How are people with liver mets doing? to get more feedback on Y90.
We're here for you!
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Theresa,
I'm sorry you've been dealing with progression. It will be interesting to see if Trodelvy works, and glad you have Halaven as a back-up. What all have you tried so far? I hope you can go back onto trials eventually and move back on targeted drugs or some immunotherapy combo trial, after the chemo...
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Cure-ious,
So appreciate your support and knowledge! The thing is, while there are many promising concepts, there aren't any promising Phase II or III trials that would accept me. Many trials are closed, exclude me for various reasons, or haven't been proven effective and safe for breast cancer. The other limiting factor is location. It may be years before some of these drugs are approved for breast cancer. Many will be canceled after Phase I due to toxicity or lack of efficacy. All that being said, I'm hopeful about Enobosarm and I still have old-school chemos, Verzenio and possibly Enhertu off-label to fall back on while I wait.
Hugs, Susan
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TIGIT inhibitors are being tested as one approach to disable the immune cells that cancers use as shields to protect them from immune cell killing. The hope is that these drugs will improve the numbers of people who respond to immunotherapy. Several monoclonal antibodies (mAbs) that block the inhibitory activity of the TIGIT receptor have been developed and clinical trials are testing the drugs as monotherapy or in combination with checkpoint inhibitor drugs. They are getting some good results in patients with PDL1 positive tumors but it is still very early days
https://www.targetedonc.com/view/tigit-emerging-as...
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Theresa so sorry for the progression!
Eribulin was the best med I was on so far...easy peasy the infusion is only 15 min 2 week on 1 off...I had virturally no side effects apart from having to shave my head and it works great on liver mets. I was sorry to be able to get 3 months on it.0 -
I'm not sure where to post this, so will post on multiple threads. I am so discouraged, depressed, angry as I explore getting different treatment options, including clinical trials. This is the third BC for me. Is each one "new" or did the original beat the treatment? I'm not sure if any of the treatments worked. Just talked to MD Anderson and they indicated they would not do anything different unless it was shown that the new treatment I just started fails. They would not consider me for clinical trials either. Is this generally the way it is with getting 2nd opinions on treatment options? Dec 2019 showed metastasis through skin, but nothing found in organs. Do I have to wait for it to show up in organs before other treatment is considered? That is so wrong.
2009 ER+ left breast. 52 yrs. Lumpectomy, Sentinel node removal, negative. Radiation 6 weeks, tamoxifen 5 years. Dense lumpy left breast, normal right.
2016 ER+ left breast. Probably a new cancer, but unknown. 4 rounds TC Aug-Oct 2016, Bi-lateral (my choice) Nov 2016, no reconstruction. 2 sentinel nodes remove, negative. ). Anastrozole 1 mg starting May 2017. Joint issues noticed immediately. Stopped Anastrozole after 3-4 months due to joint stiffness in. After several months of no AIs, fingers were feeling better. Started tamoxifen March 2018.
6/2019 Swelling in opposite arm, urgent care, no clot, lots of fluid. Scans, biopies etc, new tumor R-axilla Dxed 8/2019, ER + 85%. Start Ibrance/Arimidex 9/2019. CTs suggest Ibrance working. With LE and compression pumps starting to get control over lymphedema.
12/2020 - noticed "rash" and thickening, had been noticing loss in range of motion which I attributed to an old injury and getting older. DR says Ibrance/Arimidex not working anymore. Cancer has spread all over chest area in skin, PET did not find anything in organs. Lymphedema getting very bad.
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bluegirlredstate, I’m sorry your facing such challenges with treatment. I obviously don’t speak for MDA but having 4.5 years of treatment there, I can share that they will absolutely follow standard protocol as other hospitals do with regard to lines of treatment. This can be frustrating when you want to try more personalized care but unless the case is rare, they typically stick to proven therapies.
I don’t know why they wouldn’t try to match you to a trial though, my only guess is that the think the best scenario would be to stick with the new treatment you’ve started, like you said unless or until it fails, then re-evaluate from there. Also, you typically have a period of time pre trial to go off meds in some cases, perhaps they think it would not be wise to do so at this point?
I don’t want you to feel written off, these are just my thoughts based on being a patient and hearing others MDA experiences. I wish you well with current meds and with whatever options you pursue in the future.
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illimae - maybe I should persue clinical more. I did not actually talk to a DR, but someone who takes down preliminary information, and he said that since I had just started a new treatment it rules out clinical until new treatment is shown to have failed. Also said their DRs would not second guess the DR I am seeing and suggest different treatment. But DRs do disagree, and how to get those other opinions?
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BGRS,
I agree with Illimae. I'm not a doctor but I do think there are lots of proven, efficacious, and safe approved treatments that you should try first. Ibrance is the usual first-line treatment but Xeloda, Abraxane, Piqray (If you have a PI3KCA mutation), Enhertu (off label), and Trodelvy (off label) should be available to you as second-line treatments without being in a trial. Have you had genomic profiling, Foundation One or UCSF 500, done? Also, sequencing is important and may affect your ability to get on future trials so be sure to ask your MO about that.
Sorry to hear about your Lymphedema. Have you tried Lymphatic massage?
Hugs, Susan
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BGRS- I really care that you are going through this hard time. I can empathize with you in some areas.
I can't remember what you are taking now but it is typical for clinical trials to want you to be refractory to your current meds before accepting you. But that can be as little as 2 months on meds to determine efficacy. Can they do a skin biopsy since you have no solid tumors according to your PET? It would be good to have some next gen sequencing if possible.
as others said, there are a lot of meds still in your bucket BUT getting on the right clinical trial takes time and timing is important. It took me almost 2 years and lots of hours of my own research to find a clinical trial that sounded worth the effort and I qualified for with my other issues.
I have found Sarah Cannon Research Institute in Nashville to be a great place for breast cancer clinical trials. If you are able to travel, go ahead and get started on their intake process now and ask for Dr Hamilton.
My MDACC experience is standard of care. I was hoping for novel therapies but they would not look outside the box for my neuroendocrine features. they took me on as a 2nd opinion at metastasis only if I would consider clinical trials. I had not started any treatment- I was hoping for surgery, but MDACC said no. I love my MO because she talks to me and explains the scans and goes over the research. I asked for y-90 to the liver and she supported me. But She only looks at MDACC breast cancer trials of which I did not qualify. I found all of my clinical trials myself! So frustrating
I hope you can take time to process all that is going on. sometimes aclosed door means another one will be open. I hate that you are overwhelmed with the process but know that feeling well. Prayers that you find the right path and have peace while you are waiting.
Dee
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Dee, such important points- we have to know what treatments we want to consider and contact those trials ourselves, but also consult MOs at the big cancer centers in case they suggest something we've never heard of, and have an FDA-approved backup in case we don't get into a trial, and be ready to do all this and make the decision under the stress/duress of progression...
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Bluegirl, I’d definitely want to hear it from a doctor, not nurse or anyone else. And, I know doctors do disagree, which makes it worth further consultation, if you feel strongly about it.
Personally, I could get the treatment I’m receiving currently and any cancer center but I go to MDA because I want more options when things go south and feel their trials, especially with my brains mets, offer me that.
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Hi everyone
I discovered a new tool for finding trials from a breast cancer advocate I follow. It gave me trials only in my drivable area. I have not gone through all 50 suggested trials yet. It did give me a new one for CDK 2 that I had not seen (but since I failed the cdk246 I probably would not have put it on my list)
https://clinicaltrials.gov/ct2/show/study/NCT04553133
The trial search interface is ok and I told the designer I would give some feedback. Meanwhile I will share the link for those who want to try another trial searchtool.
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Allabama and Ilimae - thank you for the thoughts of getting 2nd opinion / clinical trials etc. Felt a little discouraged when MDA said it might not be worth coming down since they will not 2nd guess current and because I had just started new treatment (Afinitor/Exemestane), that it had to fail before something else might be considered. Would other major centers say the same thing? I might be eligable for immunotherapy, since gene panel showed slight PDL1 marker.
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Bluegirl, I think most probably would say the same thing only because if your new treatment is working, then presumably you’d want to stick with it. If things change and it’s not working or not tolerable, then your situation will have changed making MDA or any major cancer center a good idea for options mowing forward.
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So much is being published right now on immunotherapy- For example, apparently tumor cells have been known to take up bacteria, and new papers in Science and Nature show that tumor-specific bacteria fragments can make their way to the surface of cancer cells and can be used to guide engineered CAR-T cells to the tumor. This could allow for off-the-shelf CAR-Ts directed to specific bacteria proteins to be used in cancers where there do not exist other antigens.
Another paper has found a way to make CAR-Ts for Her2 breast cancers. The problem there has been that some Her2 is expressed on certain normal cells, so its not entirely tumor-specific and the CARs can cause damage to those tissues. A paper in Science shows a way to make a Her2 CAR that only ramps up when it finds cells with high levels of Her2, very clever. Now they can get the CAR-T to go only after the cancer cells. Still need a way to open up the tumor to immune system, but this is a big hurdle they seem now to have fixed.
https://www.news-medical.net/news/20210318/Study-e...
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Update- my ca15-3 came back this month and dropped 10 points!!! 🙌🏻 I know it is not a perfect indicator but that is the biggest drop I have ever had.
ARV-471 next scan and plan is April 19.
Dee
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Oh, Dee, that's great! Good luck on the next scan.
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Alabama - I hope they keep dropping! Good news.
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Dee
I am always excited when my drop. I hope this is the start of a lowering trend!
I feel like mine are so high all the time. My last 15-3 was 272 which is up from 98 in February. It worries me but my MO keeps saying she isn't worried because my Feb scan was good.
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How often does DR check tumor markers? I have regular bloodwork, every month ( that might have been because I used to be on Ibrance?) Since Sept 2019, mine have been checked 5 times. Last reading 48.3 FEb; 55.3 Jan; 50.4 Dec 2020; 43.1 Aug 2020; 25.6 Sept 2019. Just went through an episode of pleural effusion.
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BGRS- my tumor markers get checked monthly because of my trial. Insurance won't cover any sooner than monthly for me. I was getting them every 1-2 months at the beginning of metastatic. I suppose you could ask your MO for more frequent/regular TM checks to plot a trend against progression/stable/response. If you are curious and insurance covers I don't see why not asking.
TMs just aren’t that reliable and can cause anxiety watching them too close. On the other hand. The MOs will tell you they like to see the numbers drop especially back to normal range.
42 is the highest my CA 153 has ever been. Some peoples can read in the hundreds or more. My recent drop was from 40 to 30. The big change downward is what encourages me. But I have had progression while the TM's went down slightly so they are not the best indicator for me.
Hope this helps😉
Dee
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