Are you currently (or have you been) in a Clinical Trial?
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After watching the video about the TILs study I contacted the surgery branch of the National Cancer Institute and had a thorough conversation with the woman who answered. The TILS age limit of 18-70 yrs is described as "ideal" in their frequently-asked-questions handout, so I wondered if there was wiggle room. She said I probably would not be eligible, but she gathered information about my dx and rx and submitted my name for other clinical trials within my zip code. I said I'd be willing to travel. Being new to all this I decided to submit the on-line application for TILS anyway. I received a kind response the next day explaining that they have an "age limit of 70 for their immunotherapy trials" so I would not be eligible. No wiggle room in "ideal", but hopefully I learn about more clinical trails.
Thank you to all for your help and sharing.
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Hi Susan!! Well there are folks on this site who are on longer than I, but in my case I had widespread bone mets in 2015, spent 3.5 years on Ibrance-Femara before a new spot appeared on my spine and smouldering mets on my hips- we treated that with SBRT rads and then I got another year and a half before real progression (still in bones) and moved over to Ibrance-Faslodex and here I am, w/7.5 yr scans coming up in the fall. Very grateful and would like to hear from others who're in the same ballpark!!!
WeninWI- What the heck is with 70 as an age limit? Geez Ive seen trials with 90 year olds?! The only thing I can imagine is they want to keep the treatment for younger people who need to go far longer to have an average lifespan and could run out of options while still young. But hey, we all need options!! Hopefully more trials open for autologous cell transfer, there are a few around but have not seen other ones for MBC...
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Hi NKB!!! Good to hear from you!!! So, the original reports with Verzenio said they have a good PFS, like 16.5 months, for later-stage patients as monotherapy. That sounds too high, but I'll try to find it. It's also good for liver mets, cross the BBB, etc. there are reports in scientific literature that CDK4,6i resistance can clear away quickly and you can go back to it, but I haven't kept up with clinical trials. Are PARP inhibitors an option for you? I think those are good drugs but you have to have a BRCA1,2 or some other kind of DNA repair gene mutation (PALB, CHEK2, and a bunch of others)...
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Hi Cure-ious- still relying on my quilting as an anti-cancer supplement!
I thought about trying to circle back to abema alone ( if MO agrees) seems like it could be as effective as Doxil- I heard that was 16%, but, I don't really know. Had PET yesterday and it showed some mild progression in some bones, and some bones better- I don't know what MO will say next week- trying to think of next steps. still on Xeloda.
I have no BRCA, CHEK2 or PALB or ERS1 or PIK3K etc. just the CCND1.
Am still bone only so trials not a possibility. I am going with the thought that if you get 6+ months on something, something else might be newly available- but, really thinking that if not in organ failure etc- regular chemo may not be more effective than circling back to a CDK4/6i , but, I don't have the data. Then there is Enhertu- seems like they have been using that as a Hail Mary- now it will probably be used sooner and many more ADCs in the pipeline.
Yea! for 7.5 years and counting!
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NKB, You got it sister! Quilt Therapy!!! I'm still BUMMED about the age 70 threshold for the Rosenberg trial- I'm not there yet, but I'm hardly wanting to rush to get liver/lung mets just to qualify and try to get onto that trial?! In other interviews he said overall with the various cancers they have tried this approach on, they have cured about 25% of the metastatic cancers- CAR-T is in that category for multiple myeloma. There are a couple of smaller TILs trials out there, like one at Yale for 10 TNBC patients, but not a lot. Hopefully big pharma is pushing on this. Nat Med just published on an mRNA vaccine for neoantigens that looks good, but its just So you are right- how to identify treatments or trials that allow us to tread water waiting for better options to come along. And deal with the fact they would prefer immunotherapy to come sooner than later for best results, and that trials aren't there for bone-only disease. There should be some bigger SERD trials coming up that may be directed to second or third line, I'm hoping more big news comes before the end of the year, ESMO is next month...
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nkb - I also tried to get into the TIL trial at NCI. I was turned down because of bone only, along with one tiny brain met that was treated with SRS two years ago. Tumors not easily accessible they said. I was doing weekly Taxol, which seemed to be working well on bone met. Then July 11th, my brain MRI revealed multiple brain mets. Apparently too numerous to count 😳 . My options were WBRT or Enhertu based on being Her2 1+ for the last 2 years. I was originally triple positive until 2020. Both my MO and RO recommended trying Enhertu first, since the risks associated with WBRT are more severe. I am awaiting a second opinion consult, but have started the Enhertu for now. When I was bone only, I found it super frustrating that I was turned down for every trial I tried to get into, yet none of the SOC drugs worked for me. Now I feel that I’m doing a Hail Mary, perhaps due to not being admitted into these promising trials 😡. I also have the CCND1 amplification along with FGFR 3, 4, and 19 - which is why I feel that I am endocrine resistant.
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To All,
Has anyone tried the Dana-Farber Cancer Institute Online Second Opinion Program? What was your experience? Would you recommend it? Was it worth the $2400 cost?
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To All,
Finding applicable studies on ClinicalTrials.gov is not easy. It seems every time a query I come up with a different list.
Who can a patient turn to for assistance in finding all clinical trials (beyond those offered by their provider's institution) that are personalized to the patient?
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To All,
I just read about a study for non metastatic breast cancer patients that demonstrated the use of personalized circulating tumor DNA (ctDNA) profiling for detection of recurrence in breast cancer.
https://aacrjournals.org/clincancerres/article/25/...
It's too late for anyone with MBC, but I wonder to what extent this test is being used in clinical practice? I asked about being screened after my Stage IA diagnosis, lumpectomy, radiation, and start of hormone therapy and was told they don't go looking for recurrence.
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weninwi,
That response, "We don't go looking for recurrence" makes me really angry. It is emblematic of how most of us were misinformed about our risk (30%) of becoming metastatic. I was Stage 0 so my then MO said I had nothing to worry about. They would screen me and keep catching it early. We need to have clear guidance about the risk of early-stage BC becoming metastatic because it influences the choices we make at that point and afterward. For example, I chose not to take Tamoxifen post-adjuvant and turned down paying for more disability insurance.
Hugs, Susan
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Susan,
I reread your personal story and disease and treatment history. How overwhelming. You're certainly a survivor. I hope I can muster similar strength and endurance. Some days it's hard and lacking full confidence in my MO doesn't help. I'm pinning some hope on getting a worthwhile second opinion and maybe even a third opinion. I have considered getting an appointment at the Block Center of Integrative Cancer Treatment if I stabilize again.
Wendy
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wen,
Appreciate your kind words! There are many on this board and my support group whose strength and resilience have inspired me.
I believe that maintaining hope is the key to dealing with this horrible disease. Late last year, I struggled to remain hopeful thinking that I was near the end. I even completed the End of Life forms and screens so that I would have access to drugs to end my life. My Traditional Chinese Medicine doctor gave me a lecture about how I needed to believe that I was going to keep living. Eight months later, I am doing well despite some progression on paper.
For sure, the right team to support you is imperative. Getting other opinions may help you find the right people. I wish you the best.
Big hugs, Susan
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Weninwi and Susaninsf - I don't want to hijack this thread, but the reality that early stage patients are not screened or monitored well is a HUGE ISSUE.
I lost a friend this spring, dx 2008 with DCIS only, completed standard of care including femara for 5 years. It came back in 2015 and she died 2/2022.
I was stage 1 node negative, did all treatment. I have never had scans beyond mammograms and breast MRI's due to node negative initial cancer. I started having some unusual "symptoms" in July of 2019 and was not allowed to have scans, told I had a virus and called paranoid by my oncology team (Seattle Cancer Care Alliance) and my GP since my mammograms have always been "beautifully clear" after surgery/chemo/rads/7 years femara. Took me 4 months to finally have scans that showed recurrence that had spread.
It is hard not to be bitter and think tha a petscan at some point after treatment or at least when my weird symptoms started I could have caught this earlier.
I agree with SusaninSF's chinese medicine doc and choose to stay positive, I am doing fine on first line and visualize that continuing. However, we need more monitoring of early stage patients.
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Aprilgirl, I’ve never been early stage but since we all know that cancer can and does metastasize through means other than nodes, I agree that those patients should be taken seriously. Of course there’s anxiety and the cost of scans but with confined symptoms of something going on, doctors and insurance companies should approve further testing, at least annually, in my opinion.
I don’t post here much and my trial experience has been limited but I read and appreciate all the contributions here, thanks so much for doing and sharing.
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Hi Aprilgirl,
I completely understand where you are coming from and also believed that I would want to know right away if the cancer has spread. I too believe that they need to pay attention to symptoms (the respirologist that tapped my lung scoffed at the notion that it could be BC after so many years - he had to eat crow). However, the reasoning of the medical community in not doing more regular scans is that finding metastasis early has no impact on the patient’s life span and it does harm in terms of radiation exposure and added stress. It’s always hard to wrap our heads around this but once its spread the genie is out of the bottle and finding it early doesn’t help (the exception would be rare oligometastatic patients).
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cure-ious,
My liver biopsy was ER+ PR+ and HER2 low 1+. My broader genetic test results are not back yet. I'm starting to wonder if my treatment options have now narrowed because of the HER2 low result. Does the HER2 low finding mean my likely treatment options are now limited to only drugs thought to be effective for Her2 low, such as Enhertu? Or would other treatment options still likely exist based on mutations that may show up, such as a PI3 kinase mutation?
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weninwi,
Having Her2 low, as far as I've experienced, is a big plus since it has opened up a lot of new options for me. However, I am HER2 2+ and some trials won't admit HER2 1+ patients. That being said, if you have responded to a HER2-targeted treatment previously, they may give you the nod. This happened to me in trying to get on the BDC-1001 trial. Technically, it is for HER2-positive patients but they were able to admit me since I had responded to ARX-788 which is also a HER2 targeted ADC. The advent of ADCs and the classification of HER2-low has given me a lot more time. I thought I was pretty much out of options at the end of last year.
Hugs, Susan
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Weniwie- Her2 low as Susan says opens up some more doors for treatment- you can still use the treatments for HR+ which are oral until you exhaust them- and then check out the Her2 low treatments. Some markers like BRCA, Chek2 and Pik3 may give you even more options.
I have heard many researchers say that it doesn't matter whether your are Her2 1+ or 2+- it is an artificial line and the data on Enhertu for Her 2 low was not different for 2+ vs1+.
Susan- what is BDC- 1001?
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nkb,
BDC-1001 is an immune-stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist. So it's similar to an ADC but delivers an immunotherapy payload instead of chemo. In later parts of the trial, it will be paired with Nivolumab.
Regarding HER2 status, the artificial line was at 3+. That line was what separated HER2+ from HER2-. The line was drawn there because Herceptin, then the only HER2-targeted drug, did not work for anything under 3+. Newer, stronger drugs can work on lower levels of HER2.
There have been studies questioning the accuracy of 1+ test results. Perhaps this is why the ARX-788 trial I was on specifically allowed only HER2 2+ or 3+.
Hugs, Susan
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Oh, Susan, that is so interesting!!! A TLR7,8 targeted ADC?!!! Are there any SEs?
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Thanks, Susan. I had heard a drug like that was in the works- had no idea it was already being tested!
Good luck - it sounds very exciting- where is the trial taking place?
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Cure-ious,
I was supposed to start treatment today but haven't heard back from anyone since I last saw them two weeks ago. I sent several MyHealth messages and still haven't heard back. Called the main number and the person there sent them a "priority" message to get back to me. Still nothing. I met the whole team two weeks ago and they all seemed great so I'm surprised at their lack of communication.
It's still in the Part I dose escalation phase but so far they say they have not seen any serious SEs. They have had some infusion reactions so they have slowed down the infusion to take over an hour.
Hugs, Susan
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So my appointments got rescheduled for today, Thursday. Originally, I was supposed to get the first treatment on Monday. On my way down to Stanford, the nurse calls and says that they forgot that I have to get a brain MRI before starting! The team figures out that the only way I can get a quick MRI is by going to the ER. Luckily, the ER is pretty much empty and after some cajoling, they agreed to let me get an MRI. The radiologist says that he can't expedite the report so I was told that I wouldn't be able to get my infusion today. On my way back to SF, the MRI report came back. The report says I have progression (two 2mm tumors are now 3mm) including "a small more conspicuous area concerning for leptomeningeal disease"! I just had a brain MRI on 7/20/22 at UCSF that showed stable disease. My brain has been stable since my last gamma knife in 11/2017. I really think this is a difference in machines and radiologists but I am now worried that I won't be able to start the trial. If I can't get on this trial then I will really have to scramble to get on another treatment since my last Enhertu infusion was on 8/2.
Worried, Susan
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Susan- I hope that it all gets figured out very soon. of course it is a holiday weekend also seems like an MRI less than 6 weeks old should work fine-
Sorry you are worried. fingers crossed
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Susaninsf
Oh boy that is a worrying turn of events. I hope you can get (good) answers tomorrow.
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Thanks, nkb and newgardener.
So my MO and the Stanford doctor agreed that it was likely just differences in machines and radiologists and not progression. Whew! Hoping to start next Tuesday.
Now I just have to worry about SEs, effectiveness, longevity of effectiveness. All the things we worry about when starting a new treatment.
Hugs, Susan
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Der SusaninSF - I absolutely agree with you that the difference must be in evaluation techniques. Could you find the radiologist who evaluated your brain MRI on 7/20/22 at UCSF and ask him to compare? That would be super important... for sure it is just different softwares and different way radiologist sees size...
Saulius
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So my MO and the Stanford MO both agreed that it was likely machine differences but the Stanford radiologist would not budge so I was kicked off the trial. Apparently, the main issue was one punctate lesion he insisted was not on the previous scan. So insane! This is after jumping through so many hoops and being off of treatment for a month! Moreover, the trial exclusion is not "no active brain mets" but "no untreated active brain mets". I would need to radiate that punctate lesion and then wait another month. The Stanford doctor said that he cannot recommend that since there is no reason to radiate a punctate lesion.
So now, I have to find a new treatment. UCSF will be offering the PY-314 trial soon but I will likely need a treatment bridge before that can happen.
What a roller coaster this has been!
- Susan
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Susan,
You have been such a good source of helpful information, support and encouragement to me. I hope the best for you.
Wendy
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Susan
what a crummy outcome! so sorry. strange to cherry pick out and eliminate so many patients and when approved give it to all sorts of people who were never even studied.
What is PY-314?
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