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

PPS Just noticed you had the kat6i with fulvestrant and cdk4 i.

@mommacj Thank you for your reply. I will check those out.

Take care!

Perky, I'm so glad you brought up KAT6, there is news there, apparently you are not the only one responding so well. According to the link below, Pfizer is rushing KAT6, moving from phase 1 directly to phase 3, presumably staying on just 5 mgs dose (they tried 1 mg dose but it didn't improve side effects- can you imagine taking 1 mg of any cancer drug? amazing!). And Pfizer knows how to push, I started on Ibrance just 3 mos after it was approved, and it had not yet even finished phase 3- the numbers were so good that FDA approved the drug as soon as phase 3 trials had filled up, and made it contingent on finishing up the trial with numbers that qualified it for FDA approval going forward. So maybe we can get lucky and when phase 3 fully accrues, we could get access to this drug? Thanks to people like you who did the trial and got such great numbers! Main side effects are dysgeusia (metallic taste of food) and neutropenia, did you have side effects? and what dose were you on?

https://www.oncologypipeline.com/apexonco/kat6-marks-another-phase-1-3-push-pfizer

And here is the summary of KAT6 trial results from the 2025 ASCO mtg: For those who did respond, the median duration of response was 15.7 months, amazing! No pneumonitis seen, ORR (ie tumor shrinkage of at least 30%) was 37%, these are great numbers! Its for patients who have progressed on CDK4.6i, secondline and beyond.

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2025.43.16_suppl.1020

Hi everyone:

How's this for a plot twist?

My doctor messaged to say that the progression was NOT significant enough to change treatments yet. He said he saw nothing in the liver that would explain the high liver numbers, so he believes it is drug toxicity. He wanted to retake liver numbers in a week and then we'd decide what to do.

Fast forward to yesterday and my liver numbers went down, confirming his suspicion of drug toxicity. He reduced the dosage and I had my Datroway infusion 4. So overall, great news. Yay!

However, I overreacted to the scan report and blabbed it all over the place without waiting for the full data and his opinion to come in. So sorry about that—one of these days I'll learn not to jump the gun.

This rollercoaster I've been on is annoying—one surprise after another. Hard to stay focused on anything else when I don't know what to expect. It's still a scary situation, but like cure-ious said, it will give me time to research and be ready for the next treatment after Datroway and Talzenna.

Thanks so much for all the support during my false alarm freakout. It is more appreciated than you know.

CBL

Hi Tinkerbelle!!

I was on pitavastatin, and it worked well with much less muscle pain than the other kinds of statins gave me. However, I had to go off of all statins for the trial I am on, because its somehow not compatible with the trial med. In future, I really want to go onto a PCSK9 inhibitor, which has (at least in the lab) multiple powerful anti-metastatic cancer activity that statins do not have, and drops the LDL by like half, way stronger than statins. It can also raise up the good cholesterol HDL, and lower triglycerides. Unfortunately, it is incredibly difficult to get, because insurance insists you go onto a statin, since they are much cheaper, and they really don't care if you can't tolerate a statin. I even had a prescription from a cardiologist who wrote I really need it, but again, they don't care, you only get it if your cholesterol numbers are some very high number, basically through the roof. In terms of metastatic cancer, it has the potential ability to prevent mets from forming for many solid tumors and synergizes with immunotherapy, which is when I would want to take it, so I hope some cheap pill version will have come on the market by then (its an injectible) or otherwise I will have to go pay for it myself. The data look promising that it should have very different (and much stronger )anti-cancer activity than a statin. But of course statins have anti-cancer activity in themselves, because high cholesterol can drive cancers, its just that the PCSK9 affects other things independent of cholesterol levels that are needed for a cancer to metastasize, so it has additional activities statins don't have. I'd love to try it and see if it prevents new mets from forming, and/or shrinks mets while also fixing the cholesterol. It is also cardioprotective, blocks the atherosclerosis one can get from immunotherapy.

Ha!, CBL, I love your humor!!! Yeah, I could literally kill for a margarita or glass of red wine sometimes, but the cancer is far more important and dropping alcohol was probably a good thing for me anyway… Well the drug team knew their trial drug wasn't the problem, because the liver enzymes were fine for the first four months. They might have been wondering if I was messing around with odd supplements or alcohol or whatever outside of the agreed-upon protocol, which, as you know, is verboten, but the Dr let them know many things can cause transient jumps in those numbers, and since then its been fine

@cure-ious. Thanks for the explanation re Pitavastatin. I had a Cardiac CT scan calcium score which was 23 (mild risk) for CAD but yet I'm in the 85th percentile for a significant lifetime cardiac event. Hence the PCP is pushing a low dose statin. Unfortunately, the PCP said I would have to fail statins and have a major justification for PCSK9 inhibitor. I truly don't want to add medication, but it sounds like Pitavastatin would be the option since being on Ibrance. It's good to here you didn't have difficulty on the medication, which is helping me to make a decision.

So sorry for the late reply. Grandbaby number three came. A sweet baby girl! 💝

Yes, I did the Kat6 trial with Fasoldex. Interesting because SOC typically does not go back to a drug that failed. Makes me wonder about Ibrance and some of the new SERDS. That was such a relatively easy treatment!

I have low esr1, no pik3...but I do have a Kat6 mutation. Not sure if that helped but it wasn't required for the trial.

SEs were relatively easy in the kat6 trial. Dry eye. Lots of fatigue and loss of taste, especially anything salty. Sad to move on but hopefully elecestrant will be a good run as well.

If I can get my insurance to cover it, I want to add a CDK4/6.

Any thoughts on what to combine elacestrant with? I see people doing all three cdk4/6s as well as Everolimus. I am hoping to save verzenio for when it combined with imlunestrant gets FDA approval. I think it has been in the works for approval since December.

The histrosipsy went well I think. They were able to Target two of the three tumors. The smaller one was too deep for the machine they have. They said they are hoping to get a improved machine in about 8 months. I am still waiting for scans to confirm they were able to completely eradicate the two they targeted. I understand unlike radiation they can do the histrosipsy over again. SEs were really just recovering from the general anesthesia.

Beautiful blessings to all and much gratitude for this group and all the amazing research and sharing.💕

Thank you Luce! No wonder there has not been a peep about the FDA approval. I wonder why they pulled back.

@perky2020

Congratulations on the new granddaughter! Grandchildren are human sunshine.

Also, wonderful news on the histotripsy.

Thank you for sharing your experience on KAT6. This thread continues to be the most informative and useful source I've discovered in my research.

I don't have any technical knowledge or much experience to add as I am still on my first line, Kisqali/Faslodex/Xgeva, for 40 months now. In a discussion with my MO about future treatments, she asked if I would be willing to "circle back" to Kisqali at some point, so repeat cdk4/6s must be a possibility.

Hi Eleanora,

I don't know about Minoxidil prescriptions, however I use the topical foam every night because my hair has gotten so thin after 10 years of anti-estrogens and CDK4,6i for MBC. And it has definitely helped, and doesn't raise my liver enzymes or do anything bad, and hopefully the low-dose prescription would be just as well-tolerated and of course more effective than the topical

But, it is so funny you would write this today, as I was just literally texting family and friends about a possible breakthrough now in clinical trials coming out of UCLA, will post the details below..

So, UCLA has uncovered what could be a big step for reversing hair loss and thinning- its a topical treatment called PP405 that activates dormant hair follicle stem cells and can work on people who are either partially or, totally bald, regardless of how long they have been bald, or have alopecia from stress or genetics, or lost hair from chemotherapy, etc, etc- the whole gamut of people who would like their hair back. It turns out the stem cells for hair have not been destroyed or permanently inactivated, but rather are in a dormant state where they use mitochondria to make ATP, rather than burn glucose.

And so this is a metabolic drug which flips that switch and causes the follicles to use glucose again for growth, so the hair follicle stem cells then can move from being dormant to growing. And unlike Minoxidil, which gives like a peach fuzz, this can restore all the phases of the hair growth cycle. The drug moves them from using mitochondria to make ATP energy to burning sugar, and thats what's needed to reactivate them.

They are just finishing up an early phase 2 trial, where about one- third of the people they tested re-grewy ca at least 20% new hair in just 8 weeks (compared to zero taking placebo). So its seems to work well and relatively fast. I'm not clear if one would have to take this the rest of their life, as is the case with minoxidil.

They are no longer recruiting people into this trial as they wrap things up and will presumably open the next one fairly soon, probably a larger phase 2 but maybe even phase 3. Importantly, there were no side effects, and the drug is a serum applied to the scalp which does not get into the bloodstream, so doesn;'t interfere with organ function, or other meds people take, nor affect hormone levels. So I hope it turns out to be a big deal, and maybe can move quickly through the various trials, as they can quickly determine whether hair growth happened, to what extent, how stable it was in the longer term, etc

Here is a link to the trial:

https://clinicaltrials.gov/study/NCT06393452

And here is a description from YouTube:

Yep, me too, harder than hair, apparently…

@cure-ious, this is so interesting because my nails still crack. I just have to keep them really short so I guess the MSM hasn't helped them at all but my hair is thick! I take 4 g (1 tsp ) of MSM fine powder each morning in water. I've taken it for at least 5 years, I think. So far no problems with my lungs or any other progression. Interesting about the glutathione.