SOLAR-1 clinical trial

thinkpositive

Anyone on this trial? My oncologist is recommending it for me.

https://clinicaltrials.gov/ct2/show/NCT02437318

zarovka

Thinkpositive - this is an interesting phase III trial of a kinase inhibitor called Alpelisib. All the drugs ending in "ib" like palbociclib (Ibrance) and ribociclib (Novartis's answer to Ibrance) are kinase inhibitors. Ibrance works in the sense that it has been significantly delaying progression in hormone receptor positive patients.

It looks like Alpelisib is a different kinase inhibitor that specifically targets cancer with a certain PIK3CA mutation. Here's an article that discusses the results of the phase II trial. When you review the outcomes of the phase II trial, remember that phase II trials enroll people who are very late stage. It seemed to almost double time to progression in a very challenging (but small) population with mild side effects.

Kinase inhibitors are changing the landscape for stage IV treatment. Something to consider.

If you post your diagnosis and treatment history in your signatures, it helps us understand where you are. Edit your profile AND make it public.

>Z<

thinkpositive

Zarovka - Thanks for responding.

I have posted my diagnosis and treatment history in my signature and made it public.

I have recently progressed on letrozole/ibrance and my oncologist is now recommending this trial for me. My tumor tissue still needs to be tested for the PIK3CA mutation though. If I do have it, I would be eligible for the trial. If not, my oncologist recommends going on Faslodex only.

zarovka

you can also consider adding keytruda to ibrance and letrozol. there is a clinical trial in los angeles doing this. keytruda is an FDA approved drug for lung cancer, but i am seeing it prescribed off label for breast cancer. your onc seems adventurous and creative, so might bring this up.

JFL

Zarovka, do you think insurance would cover Keytruda? All new cancer meds are super expensive and the insurance companies do what they can to try to avoid covering expensive meds. I would definitely ask about Keytruda of there is a chance my insurance would cover it. I suspect there are many good treatments out there currently being used for other cancers that would work for BC.

thinkpositive

Zarovka, the only reason my onc is recommending the SOLAR-1 trial is that she is one of the principal investigators in the trial. I am in NJ and go to an NCI designated cancer center. I don't think she would recommend a trial in LA.

zarovka

Good point. The specialty drugs are tightly controlled. It still would not keep me from asking my oncologist. If you live in Los Angeles, there is a phase II trial for Keytruda and BC. That would get one access to Keytruda without cost. If that trial is successful, there will be a phase III trial down the road that perhaps has broader access. Something to keep an eye on if you are interested.

There are several immunotherapy drugs in clinical trial for treatment of BC. Except for the Keytruda trial, they seem to be for aggressive and otherwise untreatable forms of breast cancer that don't have good treatment options.

There is no point in trying immunotherapy treatments, including Keytruda, for BC if you have other proven options. Immunotherapy is currently experimental for BC. However, there are many people who are out of good options. For hormone receptor positive cancers, once you burn through the hormonal therapy and the targeted therapy, you are left with chemotherapy. Some people have great QOL on chemo and some people do not.

Keytruda can be an easy protocol, or so I have read. As with all drugs I am sure it depends. I am doing well on my first line treatment at the moment, so I am looking at what might be available 3 to 5 years out. Glad to see there is a pipeline.

>Z<

zarovka

thinkpositive - let us know how the PIK3CA test goes, whether you get into SOLAR-1 and how it plays out. what happens after ibrance/letrozol fails is on the minds of many people in this forum. that said, fasolodex is a great drug that has kept many people stable for years. i just watched a great video on how it works and thought of you.

one thing i would do is get a second opinion before going on SOLAR-1. you want to be 100% sure that faslodex alone is the best option for you, absent the clinical trial. all doctors in research hospitals are under a lot of pressure to recruit for clinical trials. this may very well be the best route for you, but double check with a doctor not involved in that trial.

>Z<

thinkpositive

Zarovka - I am currently undergoing the screening process for SOLAR-1. They need blood work, EKG, echo, bone scan and PET/CT. I have these appointments over the next couple of weeks. I am leaning towards participating in the trial if I am eligible. One thing my oncologist explained to me is that clinical trials are always over and above standard of care. In the trial, I would get either faslodex+study drug or faslodex+placebo. Even if I get faslodex+placebo, it would be same as standard of care as the next line of treatment for me anyway is faslodex. And one thing I like about trials is that they monitor you very closely and you get frequent scans without all the insurance hassles. And if the side effects get too much for me I could drop out of the trial at any time and continue on faslodex only.

Thanks for the video. I will watch it when I get home. I am currently at work and don't want to disturb anyone around me