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

I am about to start a clinical trial and am wondering about the experiences of others. I'm feeling a little rocky and at sea, because I've been in the care of a wonderful oncologist for the past three years, and I knew without a doubt that his prime objective was the same as mine - to keep me stable and maintain a good quality of life. It was all about me.

Now, I'm embarking on this trial on a different campus and with a different doctor. I really like the doctor who heads it (he is a close colleague of my oncologist and has conferred with him), but I not-so-secretly worry that the prime focus will not be on my well-being, that it will be secondary to the study objectives. My initial meeting with the CO pretty much dispelled my fear that I would be a lab rat, but the closer I get to starting, the more leery I get. I'm normally not anxious about treatments.

I haven't had any treatment at all for several weeks, because the last treatment was ineffective and my onc wanted to get me into a trial, so the waiting hasn't helped. I'm normally pretty chill about everything, including starting new treatments, but entering a clinical trial is a different kettle of fish.

What has been your experience? Have you felt cared for?

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nkb

Thanks Cure-ious- I met her for lunch last year in SF and she was kind and thoughtful as well as brilliant and super caring. Very sad about her passing.

nicolerod

One person said I was not eligible and another said check back in 6 months after 2 brain scans...if all clear...maybe... I had my brain scan and there was no new mets but 1 new skull met

cure-ious

Nicole, If there are 3 or fewer brain mets, they only need to be stable for one month (below), skull mets don't matter...

Participants with three (3) or fewer brain metastases that are < 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.

https://clinicaltrials.gov/ct2/show/NCT03412877

nicolerod

Thank you Cure that is NOT what they told me..I am so glad you showed me that!!! I am going to show them.

cure-ious

Nicole, This is all such a pain in the butt, but keep knocking at that door, sister!!!! Whatever it freaking takes...

nicolerod

Will Do Cure!!! I emailed them Friday afternoon Ill keep yall posted

nicolerod

CURE... the surgeon wrote me back and said this: " I'm not 100% sure what the latest discussions were so forgive me if I'm a few steps behind. You are correct - you would potentially be eligible for cell transfer with only two small brain metastases if we had a mutation that we could target. But my understanding is that we do not have a match for your tumor.

Our other approach requires surgery, but recent brain metastases can make this higher risk in various ways. Unfortunately it is not justifiable for us to subject a patient to major surgery for an experimental therapy if they have recent brain metastases given these risks. Does that help clarify? Happy to discuss next week if you would like."

I told him I do not understand why they don't have a "match" for my tumor when I have one in the liver and a couple in lung that are easily resectable...???

cure-ious

Nicole- I would definitely ask to talk with her, I don't understand her message either. I don't know how else they get a "match" for your tumor except by doing the liver or lung met resection (is this the "major surgery" she is talking about, that she is worried with you having "two small brain mets"?). If I understand, they resect the tumor, sequence it and look for the "match" or neoantigens that they can engineer the T cells to go after. I think you should also stress how your cancer was ER-positive and turned to ER-negative and those cancers, like Judy Perkins and Barb Bigelow, turned out to be the ones that had the MOST "matches", plenty of cancer neoantigens, and in case they are not aware, that subtype conversion leads to a much greater response to immunotherapy than any other subtype of breast cancer.

Would it help for you to explain this to your onc and ask her to sit in on the phone call with you? And I'd put some of those details above in writing in response to her note, in case she needs to go think about it some more, you are very qualified it seems for this trial but we don't know what she is talking about. If she thinks you are too fragile to go through the whole procedure, what is that based on? she hasn't even seen you, right?

You might mention you post on this website and lots of other women with MBC do not understand the problems you and apparently many others are having getting into this trial!!

PS You might also remind her the reason you got the brain scan and did the SBRT was following their instructions, and now they say you aren't qualified? Even tho their own criteria are just one month from SBRT to their own procedure? That it makes no sense and doesn't seem to be consistent. If it is the surgery part that is too "risky", what criteria do they need, wait a couple months for brain swelling to reduce (if there is any)? And if the problem IS doing the surgery, why didn't they have you do that part before you did the SBRT?

PPS Others who have been in clinical trials, is this a normal thing? Surely not, or nobody would ever join a trial

PPPS Can you ask for an in-person appointment so you can discuss this?!

nicolerod

They just replied this to me...(this is from the Surgeon)

Hi Ms. Rodriguez,

Sorry for the confusion. The issue with recent brain mets is that they make surgery unsafe. Lung and liver surgery are both considered major surgery, and since this would be purely for a research protocol, we would be unable to justify the risk. I hope this makes sense. I'm sorry we haven't been able to offer you anything.

cure-ious

Oh, these people are SO useless! their protocol is apparently just a little too precious for real life. This trial has been going on forever and now we see why, it'll probably plod along till the end of time. This surgeon is probably the one who decided anyone over 70 is "too old" to be treated...

Anyway, how about a CAR-T trial? I saw Minerva just got approved by FDA for a second trial testing a new-gen CAR-T that is directed to MUC1, a form that is found only on cancer cells (critical for CAR-T, cuz you don't want any targeting of normal tissues), and this new vector is designed so the T-cells won't get exhausted and will even target cells that express low levels of MUC1. This new trial is not online yet but it won't be long now that the approval is in. And I think there is one for ROR1 expressing cells, they have identified a couple of antigens that are on most MBC cells

nicolerod

How do we find out if we have MUC1 or even ROR1?? I never heard of those on my prior biopsies.... CURE...is this one of the trials I see MUC1.... https://beta.clinicaltrials.gov/study/NCT05239143?locStr=United%20States&country=United%20States&cond=AREA%5BCondition%5Dbreast%20cancer&term=CAR-T%20Cell%20Therapy&aggFilters=ages:adult,status:rec&rank=3#locations

If anyone knows of any really good trials for TNBC please let me know!!!!! I would be grateful... I would prefer east coast near DC..but would be willing to travel if it looks really promising...

CURE here is another https://beta.clinicaltrials.gov/study/NCT04020575?locStr=United%20States&country=United%20States&cond=AREA%5BCondition%5DBreast%20Cancer%20Metastatic&aggFilters=ages:adult,phase:2%201,status:rec&term=Triple%20Negative%20Breast%20Cancer%20Metastatic&rank=9

nicolerod

You all should know..that the surgeon for the NIH CART trial called me this morning...and said NO....they feel that bc I had 2 brain mets (even though in the tial paramiters you are allowed to have 3) I am not eligible bc then taking a tumor from my liver (even though I have an easily resectable one on the capsule of the liver, the surgeon told me this himself back in Oct) or from my lung would be too much of a risk...he told me to check back in 3 -6 months if I have no other brain mets. I pretty much told him I think the trial is BullSH** and they are just trying to use people that will make their numbers look good! I said I meet all the criteria..my blood work and liver numbers are all in normal range...I walk every day...I meet all the enclusion criteria..yet they are telling me no....its bull crap.

cure-ious

Nicole, You have the kind of cancer they should want, to improve their stats!

Anyway, I'd go back in 3 months, to somebody other than the (total wuss) surgeon, and just keep pushing on that door. Tell them you feel marvelous and just went out line dancing or jet-skiing, that should shame them...

The MUC1 CAR-T trial you listed above is great, its at MD Anderson and UCSF and some other places. The link you put at the bottom is a trial at COH that is wrapping up- in that trial they are using an antibody that sees the chopped up form of MUC1 that is in cancer cells and not normal cells (the first trial is targeting the full form of MUC1). The announcement I saw was for the company (Minerva) that runs the trial in the bottom link, that they now have a next-generation vector with improved activity and just got FDA approval to set up a new trial. So the top link trial would be great, and otherwise I'd wait for the new trial to get set up from Minerva.

For MUC1 or ROR1, the trials would check that you have expression, but these are super-common in MBC, actually MUC1 is over-expressed in 80% of all metastatic cancers. So the trial would check you, but its very likely to be positive. I think MUC1 is what is measured in the CA27.29 and CA15-3 tumor marker assays anyway.

husband11

Oh man, that is so frustrating Nicole. Cureious, God bless you for all the work you are putting in for others.

anotherone

yes , I second what husband said

nicolerod

The MUC1 CAR-T trial at MD And. and its in Coloroado I emailed them and am arranging a telemed conf. I sent the trial to my MO and she readily admitted she didn't know much about this but she would look into it and had no issues with me consulting with them.

rk2020

Nicolerod - You go girl! I’m so inspired by your tenacity. Keep us updated. 🤞🏻🤞🏻🤞🏻

rk2020

This is a cross post:

I had a CT on Jan 23 after taking a trial CDK2 inhibitor (BLU-222) since Dec 1. My largest liver lesion reduced approximately 40% and the 2 other smaller ones are stable. No new bone mets. The scientists are excited about my response.I get my next scan results March 23. 🤞🏻I had to try 4 different anti nausea meds before I found one I could tolerate unfortunately, this one puts me to sleep (and I can sleep for hours) but it’s the better of two evils. I’ve still got plenty of diarrhea (4-8 times a day if I don’t take pills) but when I go out, I just take Imodium or lomatil and so far I haven’t had to cut short any social events. My doctor asked me if I wanted to reduce my dosage to gain some quality of life and I told her not yet. I started at 800 twice daily and that poisoned me. 🤢 I dropped down to 400 mg x 2. The rules for dose reduction are rigid. The next reduction would be 200 mg x 2. I cannot reduce to 300 mg x 2. And if they see progression, I cannot increase my dose. So I decided to continue on 400 x 2 and we can discuss it again after my next scan. I’m hoping my body adjusts enough so that I don’t have to reduce.

jsniffs

Nicolerod and others - I just received a notice that Travera (https://www.travera.com/) is now able to process tissue samples. I believe this is HUGE. I'd highly recommend checking it out. They can evaluate many drugs at a time on LIVE cancer cells, to see which drug(s) your cancer may respond to currently. They base drug effectiveness on the weight of the cells (dead cells weigh less than live cells). Even if you have tried some of the drugs in the past, they can check to see if something might work again. Since their testing process is newer, they are offering this testing for free to a subset of folks (I'm not sure if everyone qualifies, but it is worth asking). How potentially amazing is this technology? Instead of people having to wait months to see if a single drug will work (and going through all the side effects), they can possibly run a test to see which of 20+ drugs will work best.

nicolerod

Jsniffs while I appreciate your post did you know its $1000 per drug that they test on the cells??

jsniffs

Nicolerod - That is the price on their website, but since they are new at this, they are offering some people the test for free! If you are interested, I recommend reaching out to them to see if you might qualify for that free testing.

emac877

I second what Husband11 said, Nicole I am so impressed by your tenacity. I was having the same thought as you described the trial parameters and your own situation. It sounded to me like they were cherry picking to make numbers look good. You go girl! Keep hounding at them. I am here to learn from other's experience so that I'm not blindsided if or when I have to look at a clinical trial. I am very grateful for Cure-ious and all of the work you put into this and information you share here.

nicolerod

Thanks Jsniff I will...

emac and husband11.... I was really really mad about this...it just doesn't make sense. I think the surgeon (Nick) was annoyed at me...bc I was being relentless to everything he tried to say...but I am fighting for my life..so it is...what it is...gotta do what I gotta do.... Since I am a "believer" this really bothered me bc I felt at first like the Father was opening this door (when cureious told me about being allowed to have 3 brain mets) then they denied me anyway...I just couldn't tell or have a clear leading of what the Father wanted me to do... My husband said ...its not to be right now.

eleanora

Nicole

I second everything that emac said about admiring your tenacity. You are a warrior and are setting an example for those of us who may be in a similar situation. I regret not having anything substantive to help you in your fight, as I have neither Cure-ious's knowledge nor skill (bless her!), but I am sending positive thoughts and energy your way. In your pocket for the upcoming scans.

Eleanora

nicolerod

Cure- ious and all.....so I met telemed with Dr. Harvey from the trial MUC1 in Denver. sigh... A LOT to take in... they have only had 1 breast cancer patient (as far as he knows) and she was Hormone Positive..she had a 30% shrinkage but then it stopped working. Its a month wait if they accept you (if they have a spot for you) you have to be in Denver for 8 weeks. They do not do a biopsy to see if you have the MUC1 mutation which I kind of didn't like...bc then its just another shot in the dark. They had 1 colon cancer patient and 1 esophageal cancer patient the treatement didn't work for either of them. You get 3 doses of powerful chemo 3 days in a row to lower your immune system then they inject you with DONATED T-Cells, not your own. The biggest danger is risk of infection and a condition (forgive me I am definitely not spelling this correctly) called Cytoncon release syndrom where you run a very high fever, Blood pressure drops and you could die...its serious. There are 2 arms of the trial its random where you get placed... 1st is the senerio I already described. 2nd is they would inject you 2 seperate times with T-cells instead of one time.

Now he also told me about another trial they have only in Denver (Sarah Cannon) and at their Florida Sarah Cannon center.. I don't know the trial number but the drug is called SGNB74H its an ADC like Trodelvy but he said there has been a lot of success with it and with TNBC. We spoke about Trodelvy and he said he doesn't even treat with that bc he doesn't think its effective enough..I totally agreed. This drug though is given like chemo so 2 week on 1 week off...so I would have to move to FL...try and get my husband stationed there...which is not impossible..

I am very very torn... very torn.. I am praying about this and would love for those that believe in the God of Abraham , Issac and Jacob to pray for discernment for me and my MO... Dr. Harvey is calling my MO to see if she thinks I would be ok to be off treatement for a month for this...etc...

eleanora

Dear Nicole:

Once again you are demonstrating courage, strength and ingenuity in seeking every possible treatment. Prayers, positive thoughts and lots of virtual hugs sent your way.

Eleanora

cure-ious

OK, Nicole, here are a couple more TILs trials, they seem to now always have age 70 as a limit (!). The first one excludes brain mets, tho maybe they would accept if you can show they are stable? Will look around for more..

https://clinicaltrials.gov/ct2/show/NCT05576077

https://clinicaltrials.gov/ct2/show/NCT03567720

https://clinicaltrials.gov/ct2/show/NCT03449108

weninwi

Nicole,

I submitted a prayer request to Relevant Radio (a Catholic station) for all women with metastatic breast cancer, that mentions you specifically and your efforts to find a new clinical trial with access to new treatment. Intentions are prayed each day at Mass, the Family Rosary Across America, and the Divine Mercy Chaplet. I'll add you to my personal prayer list.

Wendy

jsniffs

Love it Wendy. You are so kind.

Nicole - I can't remember if you've said this or not, but have you recently repeated any germline genetic testing? I just recently saw a 2nd opinion MO, and she suggested that for me. She recommended it be repeated every 5 years because new genes/targets can sometimes be found/characterized. I was so focused on the tumor genetic testing that germline was off my radar. Thought I'd mention it in case that is helpful. I'm praying for you as well.

nkb

JSniffs- I just had a new panel of germline testing - for my daughter's sake. I had the last ones in 2014- with 21 genes. I had 64 more done for a total of 85 genes. I have no gerrmline mutations (not even genes of unknown significance) Even so, the geneticist my daughter saw says she has a 31.5% chance of breast cancer in her lifetime.