Are you currently (or have you been) in a Clinical Trial?
Comments
-
HELLO ladies, just an update on my trial. (5 chemo injections into a.target tumour and immunotherapy). I have scanned and have mix results. Some stable, some small progression. Trial has decided to keep going with the immunotherapy for now and rescan in a couple months. Stay Safe
Kathy
0 -
-
Thank you, curious
0 -
Im glad that they are keeping you on the immunotherapy; that sounds like a reasonable path to take! Hang in there and hope you are still feeling well!
xoxo Katty
0 -
Had my second set of scans on Tuesday since I got on the Sacituzumab Govitecan (Trodelvy) TROPICS-2 trial. Tumors stable. Pleural effusion much smaller. No new lesions. Happy with stable! Mouth sores almost completely gone after another round of oral steroids. Still tapering down. Will get down to 5 mgs of Pred tomorrow.
Hope you all enjoy the long weekend!
Hugs, Susan
0 -
Fantastic news Susan!! I am so glad that this drug is working for you. love the name of the drug (sassy tu zu mab) !
lovely weather here also.
0 -
yay Susan!
0 -
Yeah Susan!! maybe we will get a new sassy dance?
0 -
SusaninSF!! Yes!
0 -
Anyone on the AVIATOR trial? I am talking with them. Mostly curious about your experience if you are on this one. I do know one person on this trial. She is stable and seems happy with her experience.
Thanks.
https://clinicaltrials.gov/ct2/show/NCT03414658
0 -
Susan, what were some of the side effects of the Tropics2?
0 -
Capivasertib or Ipatisertib - Has anyone tried these new drugs?
These drugs are inhibitors of the AKT kinase, which is part of the PI3K pathway. Like PI3K, AKT can be activated when cancers become resistant to endocrine therapy. Unlike Piqray, these drugs to work on cancers with or without PI3K or AKT mutations. In a phase 2 trial Capivasertib more than doubled PFS compared to fulvestrant alone*.
More interestingly, pre-clinical studies indicate that AKT inhibitors can make immunotherapy more effective on cold tumors like breast cancers. This is similar to Celebrex and experimental EP4 drugs, which block the same pathwayand boost killing of cancer cells by the immune system
Therefore, Ipatisertib is now being tested in combination with fulvestrant and immunotherapy (atezo) in the MORPHEUS-ER+ Trial:
https://clinicaltrials.gov/ct2/show/NCT03280563
This trial is looking for people who have progressed after first or second line treatment with AI and CDK4 inhibition, so it does not require prior chemo for metastatic cancer
results of the first trial: *Women with metastatic hormone receptor-positive breast cancer lived more than twice as long without disease progression when they received the investigational AKT inhibitor capivasertib in addition to fulvestrant (Faslodex), a randomized phase II study showed.
Median progression-free survival (PFS) increased from 4.8 months with fulvestrant alone to 10.3 months with the combination. Patients with and without PIK3CA activating mutations benefited from the combination, as reported at ASCO.
The objective response rate also increased with the combination (41% vs 12%), as did the clinical benefit rate (55% vs 36%). A preliminary analysis of OS demonstrated a "strong trend" in favor of the capivasertib arm (26 vs 20 months, P=0.071).0 -
Oh no! For those of us who are on Ibrance/Faslodex, one of the disqualifying things is prior use of fulvestrant.
0 -
Cureious- I somehow remember that animalcrackers was In a trial with an anti AKT Medication- I am not sure of the name- may just have been a number at the time - do you remember any of those details.
0 -
So anyone that has done fasloxdex is not eligible??
0 -
Nicole,
This is what the info said for exclusions:
Exclusion Criteria for Stage 1:
- Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol
- Unresolved AEs from prior anti-cancer therapy
- Eligibility only for the control arm
- Prior treatment with inhibitors as specified in the protocol
I can't tell if they are considered to be currently recruiting for stage 1 or stage 2 -- this is only listed for stage 1?0 -
BevJen, wouldn't you qualify for phase 2?
0 -
Oh, I didn't notice that exclusion, however I see the trial ends next Feb, so would that be followed by a phase 3 trial or another (presumably larger) phase 2 trial? I do not understand the timing of these trials, they are so variable. Anyway if the results are promising more trials will open up and hopefully not exclude prior faslodex use! No wonder they cant get enrollment in these trials, too many restrictions
0 -
PS Stage 2 is only for patients already in the trial who drop out of the other arms; they have the option to try avastin with faslodex and atezo
0 -
Also, this trial has another interesting arm, which is Verzenio with Faslodex and Atezo. I would love to try that as secondline! The data from the ibrance trials indicates that those who responded well to Ibrance tend to not resond to immunotherapy, and conversely those who did not do well on ibrance in some cases had high PD1 and might respond to immunotherapy. But they do not know who responds anyway.
Maybe try adding in celebrex to make it work better- why don't they do more in this area?!
0 -
Cure...wow...I don't "think" I qualify as responding well to Ibrance...being that it worked great for only 3 months and failed month 4??? But not to forget I had Faslodex and Letrozole at the same time...anyway I know I have PDL1....so maybe I would do good in Tropics2. if I fail Doxil...that will be my decision in July to either try for Tropics2 or go to Abraxane... If you have any THOUGHTS on this I would love to hear. All I do know...My MO told me one of her TNBC patients is on that drug from Tropics2 and the side effects are pretty bad..but she didn't tell me what they are ???
0 -
Nicole- there are some on here, including SusaninSF, who can tell you about SEs with SG- but wow, get an immunothrapy going, for sure! I even think trying again with versenio and faslodex and immunotherapy might work? Need to consult someone who knows the data from the ibrance trials, like richard finn at ucla
0 -
Cure-ious,
Re Nicole's question -- was it you who said that the studies have shown that people who go through too many chemo lines don't do as well on immunotherapy? If that's so, then Nicole might be better served before going further down the chemo road to try out an immunotherapy trial, correct?
0 -
Ive heard that mentioned in discussion panels but it may be just anecdotal; of course some trials combine immuno with chemo; and Judy Perkins was heavily treated when she got a curative response from car-T. For me I hope to find something with immuno sooner than later but the research is so slow
Nicole, the Finn paper noted good ibrance responders tend to have low PD1, and weak responders high(er) PD1, which is why I wonder if taking immuno therapy to block PD1 would make your cancer sensitive to Faslodex-Versenio? will re-read that paper to see if there were any comments about that
0 -
Thanks Cure...in my post I had a typo...I said I responded well to Ibrance..I meant NOT well..being it only worked for 4 months
0 -
NicoleRod sent me a PM about TROPICS 2 SEs. Thought I'd repeat here in case anyone else had the same question.
I'm about to start cycle 6. So far the primary SE has been losing most of my hair. I had very little hair left after being on Abraxane so that wasn't a big deal for me but may be for others. My mouth sores came back twice and now I have Thrush but I had mouth sores before I got on the trial. I believe Keytruda is the culprit for that even though my last dose was in early January. Overall, Saci has been easy to tolerate and I hope I can stay on it a long time!
And thank you for all the wonderful congratulations on my stable scan!!!
Hugs, Susan
0 -
SusaninSF
I am currently taking Saci - on cycle 2. I was on the trial, but was randomized to Halaven. Halaven just failed so my Onc was able to get my insurance to approve Saci.I also have had easy SE. I did lose all my hair. No mouth sores, no nasea, nothing major except exhaustion. Would you share when you started to see results? I am ER+, PR+, HER2- Had a CT scan today, and there is progression. I realize that I am only in the middle of my 2nd cycle. The only drug that really worked on me was Xeloda. 18months and reach that wonderful NED.
Congratulations on your wonderful results on Saci! May you have a long run!!
0 -
LoMa, Thanks for joining! What other drugs have you been on? We were discussin some recent analyses that indicate that those people who express PD1 and are at better chance of responding to immunotherapy often do not do well with Ibrance-AI, and vice-versa. Perhaps you can test for that or check out some immunotherapy trials after your (hopefully long) time on SG
0 -
an ad, but still, more happy news about ccr5 inhibitors, in their first patient (TNBC)..
https://apnews.com/Globe%20Newswire/0e3d6eb4070641...
Leronlimab js a monoclonal antibody against ccr5
0 -
afternoon, going to my second treatment for a trial for a drug called atezolizumab , it is targeted on this trial for folks who have an elevated tumor mutation burden which is a hi level of mutation in the genes. It is a phase 2 study and I feel fortuante to have been able to get a place in tbe trial given all the covid nonsense.
Drug side effects have not been bad so I have hi hpes, failed at about 6 dif chemos prior and starting to wonder about next step. It is out of sloan and they have about 60 participating, good to meet you all
0
