Are you currently (or have you been) in a Clinical Trial?
Comments
-
Cure-ious - interesting post how ER+ tumor might not depend on ER receptors. One of my nagging questions - how do we know if it is or is not working. Feeling really discouraged. After 15 months Ibrance/Arimidex, and tumor seemed to be shrinking (CTs), it has suddenly exploded and spread through the lymph, showing up in the skin and much worse lymohedema, no organs/bones (yet). So, I've been taken off of Ibrance/Arimidex and DR wants me to do Everolimus/Exemestane. The Emestane seems to need a "boost" from Everolimus. Potential SEs from Everolimus sound really bad.
0 -
BlueGirl, Well, most of the secondline treatments have a PFS of about a year or so, meaning half go on longer than that and we hope to be in that group. You MO is banking on the cancer being more mTOR-dependent than CDK4,6-dependent, which is reasonable, but again we don't have good biomarkers to say which cancers are most responsive to most of these regimens. Good time to pick out a second opinion for future clinical trials with SERDs or PROTACs, altho you could also go in the Verzenio-Faslodex direction after a time on AA, so you still have many good options, even though its no doubt upsetting to have to be moving around. The first big meeting is AACR April 9-14; I'm always hoping for some good headlines from them..
0 -
I'm still reading along and taking notes. Thank you to all who post. I have entered on my second year in the SUMMIT trial for Her2 mutated cancers. Last week's report said "No PET/CT scan evidence for recurrent/metastatic breast carcinoma." So I stay the course and do my best to be healthy and strong and happy.
0 -
Shetland - So happy to hear your great results!
0 -
SP- Can it be year two ALREADY?!!! How sweet it is!!! Your trial is definitely on fire!! Is it for low HER2 or HER2 mutant, or both?
0 -
Shetland. That's great news. I hope you get many more months of PFS.
0 -
Dee and Shetland - Congrats on your success on your trials! I'm very happy for you both!!!!
I'm still hanging on in the DESTINY04 trial of Enhertu for HER2 low patients. I am IHC 2+., FSH negative. I feel fortunate to have been on the trial since 4/30/20 with stable to slghtly shrinking mets. Other than nausea, which I've been able to manage with anti-nausea meds, I have maintained a very good quality of life on Enhertu. My recent scans are showing some progression and tumor markers are rising, so I'm likely going to change treatment soon. I'm investigating options and so appreciate the information on this thread. I hope that Enhertu will be available to all HER2 low patients soon, but have no idea when that might happen.
Best!
Theresa
0 -
Teresa45 - I am sorry about the progression. Did they release you from the trial or give you one more Round? I know trials allow slight progression. Mine was actually mixed, some shrunk slightly and one grew 2mm but they considered that stable so I get 8 more weeks
ShetlandPony- so happy for you- keep reporting in.
Imagine- I have the esr1 mutation so Faslodex should work better than AIs, but it just doesn’t have the kick I need. (My non-medical explanation) The new oral trial serds are formulated to overcome that mutation from what I understand. My cancer finally responded to my trial drug that targeted the estrogen receptor - trial MO really wanted to exhaust all avenues for estrogen since I am 100% positive. Hopefully I can stay on for a long time.
Dee
0 -
ShetLand - that is great news.
Cure-ious - with clinical trials , is that something your DR helps you find? She has not been encouraging,but said I should start with University Medical centers. CARIS showed no mutations/targeted therapies. Only ER+ 85% . Almost all were "undetermined" with some note about a technical error and not enought sample left. My DR said that those other test woud not have lead to treatment - but if that is the case, was it testing for diagnostic with no treatment epected?
0 -
BlueGirlRedState, there are a couple online registries which can help you find trials. There was a link posted in the Genomic testing thread where you can put in stuff from the Caris test results.
I also tried https://www.trialjectory.com/ just a few days ago
There's also https://www.cancer.gov/about-cancer/treatment/clin...
I did another one a while back but i can't remember its name. I'll post it when I find it in my mail...
0 -
BlueGirl- Moth has some useful links there. So far I have not joined a clinical trial, but my MO would not be the person I would turn to, the hospital system she is associated with offers only a few trials and she would not know any buzz about possibly exciting trials. Instead you research and see what others have done, for example there are SERDs that look quite good for after Faslodex fails- and then when you find the trials you want to investigate, the NCI pages lists the emails for contact, and you send them an email to begin the process of finding out if you are eligible. For example, a trial will open up sometime this year combining the ARV-471 drug Dee is on with any of several partners, like CDK4.6 inhibitor or Affinitor. If there isn't some specific trial, just figure out where you would want to be treated and consult an MO there for recommendations. It definitely requires some effort and research on your part.
0 -
Moth - thank you for the links. Sent an email to one site, not quite sure how fill out since it is the third BC. Asked them if they would want all BC treatments.
0 -
I've been interested in the drug combo, oral paclitaxel with Encequidar. It was up for FDA approval yesterday, but it did not get approved. It's an oral form of pacilitaxel with Encequidar. Encequidar enables the oral absorption of drugs that currently can only be given intravenously due to poor oral absorption. I thought the drug combo sounded promising, but the FDA is concerned about side effects. It could possibly be approved in the future tho.
"The FDA has issued a complete response letter (CRL) to Athenex, Inc. stating that it will not, at this time, approve the new drug application (NDA) for oral paclitaxel in combination with encequidar for the treatment of patients with metastatic breast cancer.
Data from the phase 3 trial, which supported the application, demonstrated that oral paclitaxel plus encequidar significantly improved ORR vs IV paclitaxel in patients with metastatic breast cancer, meeting the primary end point of the trial. The ORR rates in the investigative and control arms were 36% and 24%, respectively (P = .01).
Notably, the rate of those who responded to treatment and had a duration of response that was 150 days or longer proved to be 2.5 times longer in those who received oral paclitaxel/encequidar vs those given IV paclitaxel." Read more.... Oral Paclitaxel with Encequidar
0 -
Cure-ious: Just saw your post from a ways back on the androgen receptor trials for ER+ MBC. It looked like that was in Australia. Have you heard of anything going on in the US on that?
0 -
Elenas, Thanks for the reminder, the Androgen Receptor booster drug (Enobosarm) is supposedly coming out with a new phase 3 trial sometime this spring, It sounds like they want to be tested for secondline right after failure of I-F, and anticipate getting a 7 mos PFS (half go longer), and positive effects on bone and muscle. From their Dec 2020 statement:
Today Veru announces the clinical results of the second enobosarm Phase 2 clinical study (G200802) which were presented at the 2020 San Antonio Breast Cancer Symposium. This was an international, Phase 2, open label, parallel design, randomized study to investigate the efficacy and safety of enobosarm 9mg and 18mg oral daily dosing in 136 heavily pretreated women with ER+/HER2- metastatic breast cancer who had breast cancer progression being treated with multiple lines of endocrine therapy and 90% who had also failed chemotherapy. Patients were randomized to receive enobosarm 9mg (n=72) or 18mg (n=64) oral daily dosing. The primary endpoint was clinical benefit rate at 6 months (defined as CR+PR+SD) by RECIST 1.1. Secondary endpoints included objective response rate, best overall response rate (complete responses + partial responses), radiographic progression-free survival (rPFS), and duration of clinical benefit. Median age was 60.8 years (35-83) for 9mg and 62.1 years (42-81) for the 18mg cohort. AR positivity (>10%) was centrally confirmed in 94.0% and 86.5% of the 9mg and 18mg cohorts, respectively.
The Phase 2 primary endpoint demonstrated clinically meaningful clinical benefit rate of 32% and 29% in the 9mg and 18mg daily enobosarm AR+ cohorts, respectively. At the time the study was terminated, the median duration of clinical benefit was not reached (NR) in the 9mg group (range 8.2 months to NR) and 14.1 months (range 11.0 to 16.5) in the 18mg group. Best overall response rates, AR+ patients that had complete or partial responses, were 35.3% and 25.6% for 9mg and 18mg, respectively. The median progression-free survival was 5.6 months (2.9 to >27.5) and 4.2 months (2.8 to 11) in the 9mg and 18mg groups AR+, respectively. Women being treated with 9mg or 18mg of enobosarm also reported significant improvements in quality of life measurements including mobility, anxiety/depression and pain discomfort.
Overall, enobosarm was well tolerated with most of the observed adverse events being grade 1 and 2. Drug related severe adverse events (SAEs) (Grades 3-4) were observed in 6 patients (8.0%) at the 9mg and 10 patients (16.4%) at the 18mg dose. There were no reports of virilization, increased hematocrit, and liver toxicity.Based upon the efficacy and safety from these clinical studies, the FDA recently agreed to the Company's Phase 3 registration open label, randomized, ARTEST clinical study to evaluate efficacy and safety of enobosarm 9mg versus an active comparator (exemestane or tamoxifen) for the treatment of ER+/HER2- metastatic breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The primary endpoint will be radiographic progression-free survival. In the Phase 3 ARTEST study design, the primary endpoint assumptions anticipate, as this is an earlier treatment cohort (2nd line of treatment for metastatic disease and prior to chemotherapy), the median radiographic progression-free survival will be 7 months for enobosarm treatment group and 3.5 months for the active comparator treatment group. As a comparison from the scientific literature, the observed median radiographic progression-free survival for chemotherapy in this treatment setting is approximately 3.1-3.5 months.
"We expect enobosarm, as a second line drug for metastatic ER+HER2- breast cancer, will have a median radiographic progression-free survival of at least 7 months versus 3.5 months for further estrogen receptor targeted endocrine therapy. Furthermore, based on the scientific literature, when women receive chemotherapy, their radiographic progression-free survival was also about 3.5 months, but with all the chemotherapy side effects. If enobosarm demonstrates efficacy, a good safety profile, and has the potential additional benefits of improving quality of life, increasing bone strength, and increasing muscle and physical function, then it is clear to me that enobosarm as an AR targeted agent could be the next drug women would consider after failing ER targeted endocrine therapy and before having chemotherapy."0 -
Wow that sounds like it would be good for me? Having failed Ibrance/Let/Faslodex, Xeloda and Doxil and now Eribulin....hrmmm
0 -
Do they currently test for the AR receptor, or is it just assumed that if you are ER/PR+ that you would likely benefit? Enobosarm is also known as MK-2866, or Ostarine, a popular performance enhancing drug that a lot of athletes have gotten busted for using. Apparently the manufacturors put it in some supplements without telling anyone.
0 -
Husband- Well, that's cool- performance-enhancing, you say?!! About time...
Anyway, they would test but vast majority of breast cancer is AR-positive, even more common than estrogen receptor
0 -
https://www.biospace.com/article/merck-pulls-keytruda-for-small-cell-lung-cancer-indication/
Wonder what this will mean for BC patirnts... I have a feeling all the quick FDA approvals that have been happening are gonna start slowing down
0 -
oh wow, that's not a good sign about the pembrolizumab but it's still got approval for breast cancer. I guess we hope for good trial results.
Btw, Roche withdrew applications for atezolizumab in Canada last year. No sign of Merck pembro application for mTNBC even though it's approved for that in the us.
As the trials keep going, the fact is some of the data is just... disappointing.
0 -
Keytruda was the drug that Joe Tippens was in the clinical trial for with small cell lung cancer. For those who don't know, he secretly also took fenbendazole, a veterinary deworming drug, and was the only one the trial to get a positive response from the keytruda. No one can say with any certainty what took place with Joe Tippens, but he is experiencing lasting remission. Was it the combo? Was it a one off response?
0 -
Husband I forgot about that > Joe Tippens and Keytruda...hrmmm interesting.
Bev...have you considered maybe adding in Fenben with it?
0 -
I would be very angry if I met tippens. "How to wreck an rct" 🤐 when we agree to participate in clinical trials we really need to follow protocols or else it really ruins results
0 -
Nicole,
No, I haven't thought about adding fen ben to my daily pill box. I am too freaked out by the use of keytruda anyway that I'm not going to add anything. Plus, I really hate adding pills to my daily regimen -- whether they are prescription or supplements.
0 -
I have been struggling with some neurological symptoms that could be due to covid, covid antibody infusion, BP med changes or even brain mets.
After covid and the infusion my BP skyrocketed. So my pcp and I worked on a plan to try to bring it down knowing it could just be temporary so we tried to stick with what I was taking and just tweaking dosages. We are still working out the meds issue, one of which may be the culprit for some of my symptoms.
Meanwhile I have sporadic, mild tingly lips, random lightheadedness, I sometimes smell ashy smoke(covid leftover) and I have daily headaches.
My MDACC MO wants me to get another brain MRI. I have had the daily headaches since last summer and started having migraines last fall. Migraines are much better, mild headaches continue. I had 2 clear brain MRI's last year but that was before December tumor progression on the previous trial.
I really don't want another brain MRI. My pcp said to wait 3 weeks to see if the change in BP meds helps the symptoms. I see my migraine neurologist in 2 weeks.
I am stressing about not telling my trial team the brain MRI request and just waiting it out until the next CT on April 19 to see how the trial drug is doing. They know about the symptoms and did not say anything. I really want the trial drug to keep working longer.
I don't want to even think about brain mets so I am not going to check out that thread right now.
Sorry this is long.I just needed to vent a little. Cancer is hard, trials are tricky and life is messy but I will keep going strong.
Dee
0 -
Oh Dee I am so sorry you are going through this right now. Tough decsions on top of being stressed about what "might or might not" be.
I have a feeling it is your BP causing the problem.
Sending you cyber ((((hugs))))
Nicole
PS VENT AWAY!!!!
0 -
Alabamadee, I understand and sympathize about the brain MRI, so I’ll only say that the sooner brain mets are treated, if found, the more successful treatment will be.
0 -
Dee,
So sorry about your headaches and BP issues. I agree with illimae. Best to get the brain MRI just in case. Brain MRIs also don't have any radiation so they are much safer than CTs.
I've had brain mets since my first metastatic diagnosis seven years ago and radiation has been very successful in keeping them stable. I know any progression is hard to take but if it does happen, I want you to know that brain mets are treatable.
Hugs, Susan
0 -
Thanks Susan & Illimae
I took your advice and talked to my trial doc about the suggested brain MRI. She said that since my change in BP meds has lessened the symptoms, they don’t suggest a brain MRI at this time. I don’t have the typical brain mets symptoms they listed other than headaches but I have had those since last summer with 2 clear brain MRIs. They will follow up with me in 2 weeks. I feel relieved for talking about it.
Dee
0 -
Good to hear Dee. I think what your trial doc said makes sense. ~Kar
0
