Are you currently (or have you been) in a Clinical Trial?
Comments
-
I called Foundation one, TEMPUS and Caris on my way to SCRI so I would know which one to ask for.
none of them take my insurance as in network. My out of network is very high and unmet.
Caris and Founationone quoted around $5000
TEMPUS offered self pay of $650
I don’t qualify for financial aid so I guess it it TEMPUS for me.
Dee
0 -
Cure-ious, I had only two mutations , ESR1 and FGFR1.
0 -
cross posting from ESR1 thread
Just talked to Dr Hamilton at SCRI about lasofoxafiine. She said the phase 3 trial is only 25% accrued and it will be a loooong time before it can reach FDA approval. She wouldn't give years but seems like I won't be waiting around for lasofoxafiine for my esr1 mutation.
I signed papers for the CDK2/4/6 trial Single agent. Scans, biopsy then first dose next week.
FYI- the arm with letrazole/Faslodex is about to open in the next few weeks. If anyone progressed on a cdk 4/6 with letrazole you may be able to qualify for the Faslodex cohort of the cdk 2/4/6
Dee
0 -
Katty, It is incredibly helpful to know that your ER-positive cancer had ESR1 and FGFR1 mutations, and that you had such a great response to the immunotherapy trial.
The link to the trial is here:
https://clinicaltrials.gov/ct2/show/NCT03661632
This Phase 1/2 trial combines Opodivo and an NSAID, EP4 (related to Celecoxib). The NSAID blocks high levels of cyclooxygenase (COX)-2, which is an inflammation-associated enzyme occurring in 40–50% of breast cancer patients, and helps expose the tumor to immune cell killing. It runs through Sept 2023. Many sites in US plus some in Canada, Belgium, Italy and Israel.
0 -
I found out today that my clinical trial (ipatasertib + atezolizumab + taxol) is apparently officially ending. Earlier in the summer they unblinded one arm (the one I'm in) and the other was supposed to continue but now it appears Roche is shutting the whole thing down. I'm the only person in Canada on that trial. They've told my MO that they will continue to provide atezolizumab to me for as long as I'm responding. Roche is apparently also shutting down the atezolizumab compassionate access program in Canada so anyone who is getting it that way is now out of luck, I guess? It's an approved drug but not in distribution and right now it's unclear HOW Roche will provide it to me (it might mean I have to go to some other clinic for the atezo IV and then to the cancer agency for my taxol).
Also I realized that there is still the issue of scans. Right now Roche is paying for my scans every 8 weeks. If they stop paying for them, the cancer agency's standard of care is q 12 weeks (or longer if not symptomatic). Not sure how I feel about going from 8 to 12. Roche also said that when I progressed on atezo and had to come off the trial they would pay for genomic testing of the new met (I think they use Foundation). I hope they will still honor that even if the trial is shut down.... So - a few things to sort out but at the end of the day, I'm apparently super lucky to continue getting atezolizumab in Canada & my MO is confident that I'm responding to it more than just the Taxol so she's happy I can stay on it.
Now I'm also wondering if I should renew my passport in case I need to go to Seattle at some point for keytruda or trodelvy if it comes to that. We seem to be really slow getting immunotherapy trials or approved here
0 -
Moth, good news that Roche will continue to provide the drug to you. I asked my onc the other day about what happens if I am still responding when my trial ends, would I be unable to get the drugs? She laughed a little and said something along the lines of, Big Pharma is bad, but they’re not so bad as to cut me off.
As far as scans, twelve weeks is standard where I am, too, though I scan every nine weeks on the trial. I don’t think that is a big difference, and if you had symptoms you could get approved for a scan sooner, couldn’t you? If the trial sponsor does not pay for that F1, the company will probably help you. That’s how they are. Renew the passport, ifnot for Seattle, for some fun trip!
0 -
Moth-renew your passport- hopefully you can go to fun places in the future -not just Seattle for meds.
0 -
Dee, If I read it right, it sounds like the CDK2/4/6 inhibitor you will be taking hits CDK4,6 ten times harder than Ibrance and does not have the neutrophil problems, have they said anything about that? And so you take this as monotherapy, it sounds like they think it will work like Verzenio, and have activity without anti-estrogens? You might be considered ideal for the monotherapy arm given that the ESR1 mutation would be more resistant to AIs anyway? so I wonder if you will notice fewer side effects in terms of bone/joint aches..
0 -
Cure-ious,
I’m glad to learn about the CDK 2 part helping with the resistance of ESR1. I hated the Faslodex shots and how very sore I was for 2 weeks following, so single agent is great. Hoping it works!
This is the severe SE list from Sept 2019 and based on a small number of patients. I think they will be updating this soon.
Severe neutropenia & febrile neutropenia
Severe thrombocytopeniaAnemia
Leukopenia
Inflammation of the digestive tract including the mouth, esophagus, stomach and small and large bowels
Multi organ failure
Cardiac arrest & Death😳
(1 person died while taking 50 mg 2/day. I will take the highest safest dose of 25 mg 2/day)mild symptoms include the normal SEs
-Nausea, hair loss, fatigue, itching, constipation, Diarrhea, Stomatitis, changes in liver enzymes....Interesting the joint/muscle pain was not on the list. Since that was my biggest complaint with AIs, I am hopeful
Dee
0 -
Hi all. Update on my situation. I went to second opinion Wed, had paracentesis today and start Enhertu for HER2- low tomorrow. I am still planning to appeal my insurance and send a compassionate use request to Daichi. However, I am starting tomorrow paying out of pocket. Insanely expensive of course and I am fortunate to even have the option to at least get started with a few rounds. My alk phosphatase, liver enzymes and bilirubin are continuing to increase. No time to give metronomic oral cyclophosphamide a chance to work. This is my last best chance. If Enhertu cannot start to improve things in 1-2 cycles, I don't know. There is at least one other treatment I can try but I have no confidence it will work given I don't seem to respond to hormone therapy and targeted therapy anymore. Verzenio + testosterone. Anyway, will keep you posted on my solo HER2-low “trial" of Enhertu. 2nd opinion MO thought that if it seems to be working, Daichi may grant compassionate use. However, she doesn't think they would grant it otherwise since they have a Phase 3 trial (DESTINY-04) underway right now to test Enhertu in HER2-low. 2nd opinion MO has patients in the DESTINY-04 trial and has been seeing good, durable responses, like the Phase 1 trial reported
0 -
JFL,
I am so happy you checked in. And I wish you much success in your own personal trial. I hope this helps very soon and improves your situation. Hoping for the best, and sending good thoughts.
0 -
JFL, I think this drug has a relative high response rate; in the Her2-amplified trials with heavily pre-treated patients they reported this:
Among the 184 patients treated at the recommended phase 2 dose (5.4 mg/kg), the objective response rate (ORR) was 60.9%, with most responders (54.9%) experiencing a partial response (PR), and the median duration of response was 14.8 months (range, 13.8-16.9).
It's very hard to hold on to hope at the beginning of a new drug, but these numbers are very good- good luck!!
0 -
JFL
prayers that it works and you get it covered. Can your doctor help write the letter? An acquaintance of mine got Keytruda compassionate and her doctor did all the work to help her.
Dee
0 -
New paper out in Cell has identified a sealed pocket between cancer cells that protects clusters of cells and enables them to more efficiently travel around the body and metastasize. They are particularly high in an agressive subset of triple negative cancers (called basal like 2). The protein epigen accumulates in these pockets and stimulates cell growth by signaling through the EGFR receptor. Now they can look for inhibitors of epigen signaling to identify a new type of targeted therapy
https://www.fiercebiotech.com/research/tumor-cell-...
0 -
JFL,
I am on a Trodelvy trial even though I am not TN. I was lucky to get on the drug instead of the control group. We have very similar oncotypes, similar met diagnosis dates and similarly long lists of treatments. My insurance pays for my scans. I don't think I've been on trial that pays for my scans.
The results so far for Enertu have been very good. Hoping you can get your insurance to pay for it.
Hugs, Susan
0 -
JFL - So glad you have obtained Enhertu to get started and hope you see rapid results along with a willingness from drug company to supply the med. Our thoughts are with you!
0 -
JFL...so glad you go to get Enhertu.!! Thank you for keeping us posted!!
0 -
I never expected how hard it is to get totally approved on a trial. Today I get a call that because of known drug SE thrombocytopenia, I need to come off my eliquis (prophylactic for my port since my first one caused a DVT) and go on LD Aspirin. I already take an nsaid for my arthritis. MO says he is ok with the change and said I can get an ultrasound of my neck/arm to be sure I am starting with a clean slate. 🤪 My vascular surgeon was operating all day and will get back to me Monday.
FYI my scans from Wednesday are mostly stable but my CA15-3 jumped 15 points to 35. 😢
Hoping the cdk 2/4/6 does its work and I can get at least 8 weeks on it to see next scans
Monday- ultrasound, Tues-IVIG, Wed-biopsy, Thursday-day one 14hrs of bloodwork and skin biopsy.
I plan to see my granddaughter this weekend and enjoy this beautiful weather.
Dee
0 -
Oh, Dee, such commotion over this. Hang in there. Hopefully this will be a great treatment for you and make it all worthwhile. Thinking good thoughts.
0 -
I'm thinking of you Dee and hoping that you are enjoying this gorgeous weekend ! It's nice in Houston , too!
I'm hoping that this very busy upcoming week for you goes like clockwork and is fruitful!
Katty
0 -
thinking of you De
0 -
Dee, it can be exhausting. Just take care of yourself, body and spirit. Anything else can wait.
0 -
Dear all, some exciting news on Trodelvy (Sacitizumab Govitecan) for HR+/HER2- population that expresses trop-2:
- The authors of this phase I/II basket trial evaluated the safety and efficacy of sacituzumab govitecan, which was previously approved for triple-negative breast cancer, in patients with HR+/HER2– metastatic breast cancer with progression on at least two prior lines of treatment. In this heavily pretreated population, the objective response rate was 31.5% and the stable disease rate was 33.3%. The median duration of response, progression-free survival, and overall survival were encouraging compared with the efficacy seen with currently available lines of chemotherapy. Sacituzumab govitecan was found to be fairly tolerable in the treatment population. The most common side effects were neutropenia (50% grade ≥3) and diarrhea (46%; only 7.6% grade ≥3). These side effects were relatively easily managed.
- The efficacy of sacituzumab govitecan was encouraging in patients with HR+/HER2– metastatic breast cancer. Results from the ongoing phase III trial may confirm these efficacy results and potentially clarify treatment strategies in this patient population.
Saulius0 -
Dee you got a lot going on. Try to take a deep breath and hang in there!
Saulius..thanks for that info and for posting it in easy to understand lingo! lol
I wonder if I should tell my MO about it....vs. Abraxane/Tecentriq?
0 -
Saulius- Excellent news, thanks!!!
0 -
0
-
I appreciate all of you and your contributions to this clinical trial forum. I'm considering a clinical trial (NCT03616587) in 2 weeks at my treatment center. It looks like I will be approved as I've gone through preliminary screening steps. The trial is a phase 1 trial combining everolimus (afinitor) and AZD9833. AZD9833 is an oral SERD (like faslodex but without the butt shots!) for endocrine-resistant ER+. There is no data yet on the trial other than some results on the highest safe dosage although a patient at my clinic has been on the trial for 6 months and is doing well. I am debating on participating in the trial or starting afinitor and aromasin. It would likely be safer to go with afinitor and aromasin but the progression free survival is so dismal, which is why I am considering the trial - hoping to get a better PFS. Am I crazy to consider a phase 1 trial at this point when I still have standard of care options available? So many crappy choices and tough decisions we have to make! Trial info
0 -
KarPC,
Since you have already had Faslodex, would an Oral SERD be likely to work? I don't know much about the Oral SERDS.
Have you spoken to your doctor about Trodelvy or Enhertu? They are both Antibody Drug Conjugates (ADC) that have been showing very positive results. Neither is approved for ER+/HER2- patients but there are trials for both for ER+, HER2 low in the case of Enhertu and ER+/HER2- for Trodelvy.
Hugs, Susan
0 -
KarPC, Interesting trial! So finally they are starting to make combos with SERDs? Did you have a biopsy after progression to try to understand why the cancer became insensitive to the I-F? Do you have a PI3KCA mutation? I guess not, because otherwise they would probably be suggesting Piqray, and for those that don't Affinitor can be a good option. However, the conventional AA combo does not have a great PFS, so one question would be how much stronger is the SERD? If you have the ESR1 mutation, the SERD might be great, or also the CDK2,4,6 inhibitor that Dee is going to try. As Susan mentioned, the ADCs have better PFS than most anything else, so that might buy you more time to figure out the next best step. It may be worth a second opinion to consider how to sequence the different drugs you would like to try, which should come earlier etc?
0 -
cure-ious,
Is their any data on ESR1 mutation and Faslodex in the 2nd line.
0
![[Deleted User]](https://us.v-cdn.net/6037276/uploads/defaultavatar/nF0ALO3I3QJM7.jpg)
