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

AlabamaDee,

If you are at least able to read these postings, I wanted you to know that I miss you and hope they will find a way for you to rejoin this board.

Hugs, Susan

Was wondering what was going on with the NIH trial of TILs. The clinical trials page (https://clinicaltrials.gov/ct2/show/NCT01174121) says it's suspended. Anyone know why or what's going on?

- Susan

Here is an interesting phase I/II clinical trial for 2nd/3rd-line treatment for 415 patients whose cancers remain endocrine-sensitive after progression on Ibrance-Femara/Faslodex: The trial is testing Giredestrant, the ROCHE SERD (thought to be best-in-class), in combination with other targeted drugs:

1) Abemaciclib/Verzenio, CDK4,6 inhibitor; 2) Ipatasertib, AKT inhibitor; 3) Inavolisib (PI3K/mTOR/AKT inhibitor); 4) Ribociclib, CDK4,6 inhibitor; 5) Everolimus, mTOR inhibitor; 6) Samuraciclib, CDK7 inhibitor

No prior chemo for metastatic disease is allowed

Is offered at a handful of sites in the US, as well as Spain, Israel, Australia and South Korea

https://clinicaltrials.gov/ct2/show/NCT04802759

SandiBeach, I was told that any chemo counted as a treatment line but I suspect individual trials make their own rules sometimes....

I use MBC CONNECT to search for trials. Anyone else using this?

www.mbcconnect.org

Sandi,

I was using mbcconnect but it's annoying that they send me an email every day saying, "You have new clinical trial matches" when there aren't any. Is this happening to you? They also don't seem to cover all of the trials or at least they don't associate them with me. I hope they will get better.

Cure-ious,

I thought that was interesting as well. Kind of like a double trial. Haven't seen that before. Every trial seems to couple their drug with Ibrance since they know that works.

Hugs, Susan

Thanks for your response, Sandi! Yesterday, I went through my matches and got rid them. None of them were appropriate. This morning, as usual, I got an email saying I have new matches. Logged into the site and the Matches were still empty.

The demographic survey doesn't ask anything about the type of BC, just things like gender, race, zip code. It is the disease history survey that asks if I am ER+, HER2- etc. No box for HER2 low. Maybe I should check the box for HER2+ so I can see trials for HER2 low.

I will try to contact them.

Hugs, Susan

I too would like to know news from the SABCS. Cure-ious you are good at all this. Any tidbits you have from the Conference?

Just an update.

Tuesday was injection day for the measles virus study. All went really well. The dull cancer ache in the bone lesion injected is gone! Hoping that is a good sign.

Apparently, the amount of vaccine administered is based on the size of the boney lesion. This trial focuses on injection in one lesion only. Had short term fever Thursday and Friday. Just tired and achy today.

Hoping that the measles is circulating and infecting the other bone lesions. Pray that this may be a break through.

Had first check in on Friday. Researchers don't give much info. Don't want any bias. Not sure I'll hear any progress or non progress till EOM.

krissy-annie,

do you live near the clinical trial site? If not, how often do you need to be up there and for how long? do they allow you to do any other necessary testing at your "home" cancer center?

I think this sounds very interesting too, but being only at one site makes it difficult to access.

Thanks for any additional information.

Hrmmm...I wouldn't be able to do weekly visits...but I will ask the trial coordinators that I have been speaking to about having the urine blood tests done at my center if that is allowed. Question can they only do 1 tumor at a time?

Im gonna PM you dont want to hijack the thread

There was an SABCS press release about the SERD Elascestrant filing for FDA approval, now that their phase 3 trial is complete. Although they are the first to finish, their data shows that the drug works better on ESR1 mutant cancers and they got a much smaller benefit over faslodex for the entire group in the trial (and did not even report what benefit they got for the subset of ER-normal cancers, which they say they are still analyzing- well, it will be the smallest of the numbers but they still expect it to be a statistically meaninful benefit, whatever the amount), and so folks are wondering whether FDA will approve the drug for all-comers, or require a test for ESR1 mutant status and have it limited to that subtype.

If approved for ER normal cancers as a replacement for Faslodex, will that be sufficient to allow its use in combination with CEK4,6i or Everolimus, etc? If so, then is it time to switch? given that it is oral and at least somewhat stronger, or better to wait for giredestrant and perhaps amcenestrant to get approved, as current indications suggest they are stronger... Amcenestrant is delayed (maybe taking longer to get enough progressions?) and giresdestrant data is due mid-2022. Anyway, 2022 will bring SERDs up as an real option, which will be a big change and something for everyone on Faslodex to think about!!!

https://www.evaluate.com/vantage/articles/events/c...

Also, there is a third SERD, camizestrant, currently in various trials.

SERENA-4 Phase III trial which evaluates the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with CDK4/6 inhibitors in the 1st-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer, and the SERENA-6 Phase III trial tests camizestrant with CDK4/6 inhibitors in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer with an ESR1 mutation.

It will be important to assess the data from these trials because these drugs do not have to show the FDA that they are better than Faslodex, just that they are not worse than Faslodex, because they are oral and not shots...

I was at SABCS but really focused on TN, and even that I was hampered with because dh was in hospital for a chunk of the conference.

However I have some things I bookmarked.

chart of trials for ER+ / hormone tx resistant https://twitter.com/stage4kelly/status/14693669034...

Dr P Tarantinos take homes: https://twitter.com/PTarantinoMD/status/1469704532...

For mHER2+ TDxd is the big story, now recommended as 2nd line, might be 1st line even?

For mTN, the new ADC datopotamab dxd is showing excellent results, including in people who previously had Trodelvy. ALSO. TDxd was trialed in TNBC and there was also a significant proportion who had response.

ADC = antibody drug conjugate (a class of drugs. Trodelvy is one. Enhertu & Kadcyla are also ADCs)

dapo-dxd = datopotamab deruxtecan

tdxd or t-dxd = trastuzumab deruxtecan = Enhertu