Fill Out Your Profile to share more about you. Learn more...

Alpelisib

2456710

Comments

  • susaninsf
    susaninsf Member Posts: 1,099

    Sary,

    That's great! My MO is still struggling to get me on the trial because you can't be on it if you have more than three previous treatments. I was on Tamoxifen for a short time, then Xeloda, then Ibrance+Faslodex. Since I was on Tamoxifen such a short time, really just a "bridge" treatment, my MO has been trying to get them to accept me. She told me she has seen great results with Alpelisib. She said that doing the steroid mouthwash prophylactically worked very well in keeping mouth sores from happening.

    Please let us know how it goes! Wishing you the best results!

    Hugs, Susan

  • susaninsf
    susaninsf Member Posts: 1,099

    Got on the trial! Thank goodness I have such a tenacious MO!

  • Daniel86
    Daniel86 Member Posts: 207

    Thats great news Susan! Keep us posted on your new tx.

    Best wishes to you

    Daniel

  • susaninsf
    susaninsf Member Posts: 1,099

    Thanks Daniel!

  • susaninsf
    susaninsf Member Posts: 1,099

    Cure-ious,

    I asked Hope about Aurora-A Kinase inhibitors and she said that so far they are very poorly tolerated so she doesn't recommend them. Still waiting to be able to get on the Alpelisib + Letrozole trial (they did add Letrozole as an option to Faslodex for those who were already on Faslodex). I was accepted but there are so many hoops to go through before you can receive the medication.

    Sary,

    Are you taking Alpelisib yet? My MO suggested using a steroid mouthwash every day to inhibit mouth sores, taking antihistamines to inhibit skin rashes, and metformin to lower blood sugar. That's a lot of added medication but they've seen good tolerance with these precautions.

  • Sary
    Sary Member Posts: 43

    I signed the lengthy consent form today. I am doing my baseline scans and tests the week after next (I am on vacation next week). I guess I will likely start the last week of August.

    Thank you for those tips. I will raise them with my doctor. I will let you know when I start

  • susaninsf
    susaninsf Member Posts: 1,099

    Sary,

    Do they have you on anything while you’re waiting? Took about a week to get Novartis to let me into the trial since they disputed how many treatments I had been on. After that my MO and Study Coordinator have moved fast. The day after I was approved, I signed the forms and did my Echo Cardiogram and EKG. Since I had to fast, I did the bloodwork the next day. Didn’t have to do any new scans because I just had a Brain MRI, Chest and Pelvis CTs and Bone Scan. I also already had tissue samples in storage so they could send that right away. They submitted my tumor and germline genetic testing (UCSF 500) to show that I have the PI3KCA mutation in my tumors. I’ve been off of treatments since 7/24 so I’m anxious to get started. I am in Honolulu through Tuesday but they think they can get me on the medication on Wednesday. If not, I will have to schedule another clinicaI visit because there is only a seven day window between last clinical visit and start of medication. So many hoops

    I feel great but I’ve been coughing. Hope that’s not a sign of more progression.

    Hugs, Susan

  • susaninsf
    susaninsf Member Posts: 1,099

    Ran into a glitch. My HER2 status has always been equivocal. When Novartis tested my tumor sample, they decided I was HER2+ and thus unqualified for the trial. My MO is trying to get that changed and we should have the final answer on Monday. In the meantime, by next Tuesday I'll have been off of any treatments for 28 days. Makes me very nervous since the whole reason why I'm switching treatments, of course, is because my cancer was progressing.

    Hugs, Susan

  • susaninsf
    susaninsf Member Posts: 1,099

    Got on the trial yesterday and took the drugs! First time in weeks that I wasn't coughing and spitting up mucous for a good part of the night. Amazing how quickly it started working. Now just hoping I won't get a rash which seems to be a common and difficult side effect of this drug. My MO has me on a double dosage of anithistamines to prevent the rash. The other major side effect in the study participants has been high blood sugar so I'm going to cut even further back on my sugar and carb consumption.

    Sary, How is it looking for you?

    Hugs, Susan

  • Sary
    Sary Member Posts: 43

    Great news Susan! I had all my scans and blood work yesterday. If all goes well I am scheduled to start next Wednesday.

  • newgardener
    newgardener Member Posts: 97

    Hi everyone, I wanted to thank you for such an interesting discussion about alpesib and trials. I don't check in here very often, but I'm glad to have read this thread.

    I've been in a trial for another pik3 inhibitor (GDC-0077) for 8 months now (in Toronto). With fulvestrant. You'll note that I have a lot history already and this is my second time around with fulvestrant. The tumours (pleura and liver) have remained stable. Blood sugar rose as expected, I'm on metformin now. I was interested in what you all discussed re fasting.

    Cure-ious I guess I don't quite fit the example of CDK4-6 inhibitors not working after mTOR inhibitor - I had a nice run on palbociclib after E/E (but with capecitabine in between)

    My problem these days is that I am running out good options and with my history it's harder to qualify for trials. I've so far also avoided IV chemo. But I hope some of these other options come through.

    Thanks!

  • susaninsf
    susaninsf Member Posts: 1,099

    NewGardener,

    I see from your history that you've been Stage IV since 2010. That is very inspirational to me. There seem to be a lot of new drugs in the pipeline and some approved ones (at least in the US) that aren't on your list. Have you been on Keytruda or Abemaciclib? Your doctor sounds like she/he is really in the know given the drugs you have been on. My MO also suggested Gedatolisib (GDC-0077) if I couldn't get on the Alpelisib trial. Another trial she talked about was NKTR-102 but that is for brain mets. Glad to hear that GDC-0077 is keeping you stable. Isn't it an IV drug? I have PTSD about IVs after some bad experiences. Guess I should update my history.

    Hugs, Susan

  • newgardener
    newgardener Member Posts: 97

    Hi Susan

    I didn’t know GDC-0077 had a name. Gedatosilib doesn’t really roll off the tongue does it. It is daily pills, no breaks. So, yes, I’m still avoiding IV chemo. I didn’t enjoy taxol much back when I was Stage II. I don’t like IVs or blood tests much either.

    My local oncologists have been very supportive, but I’ve had to travel to other centres to get access to the newer drugs. I went to Boston/Dana Farber monthly for 2 years on the palbociclib and bazedoxifine trial. Bazedoxifene is a SERM like tamoxifen. Now I’m travelling to Toronto.

    Abemaciclib is on my radar, so I was really interested to hear about the trial with Keytruda. Though my cancer seems slow...a good thing but maybe I”m not a good candidate for immunotherapy.

    Abemaciclib isn’t approved in Canada. Ribociclib and palbociclib are approved, but they are only funded by our health care system for first line patients, which leaves me out.

    Good luck!


  • susaninsf
    susaninsf Member Posts: 1,099

    NewGardener,

    Glad to hear that Gedatosilib is also a pill form. Do you take it in combination with anything else? Looks like I've still got Everolimus/Exemestane, Gedatosilib and Abemaciclib as possible oral treatments before I have to go to the IV ones. It's so terrible that so many trials exclude those who have been on several treatments or who have brain mets. We are the people who don't have other choices. Why would someone go on a trial for a first line of treatment when there are so many good approved drugs?

    We Americans always idealize the Canadian health care plan and just about everything else in Canada but I guess there are sometimes situations where you have to travel down here to get certain treatments. Have never heard of Bazedoxifene. Two years is a good long stretch!

    Hugs, Susan

  • newgardener
    newgardener Member Posts: 97

    Hi Susan,

    I’m getting faslodex/fulvestrant shots in combination with the GDC-0077.

    You are so right about the first line conundrum. Every drug maker wants their drug to be first. G

    Heather



  • newgardener
    newgardener Member Posts: 97

    Hi,

    This is a press release from Novartis on alpesib. Thought you might be interested. Of course, I found it in a tweet from Susan’s MO Dr Hugo.

    https://www.novartis.com/news/media-releases/solar-1-trial-novartis-investigational-alpha-specific-pi3k-inhibitor-byl719-alpelisib-meets-primary-endpoint-hrher2-advanced-breast-cancer-pik3ca-mutation

  • cure-ious
    cure-ious Member Posts: 2,700

    Hi Susan- Greetings from Germany!! I am on a two week trip to travel and attend a scientific meeting. I've been following your posts and am thrilled Hope was able to get you into the trial!! And like NewGardener, I noticed the post about Alpelisib out today, but they don't give the details!!Just that they made their primary endpoint, showing some advantage in PFS, but we have to wait for some unspecified meeting to find out how much better than faslodex alone?!!Maybe they are waiting for Susan to push that curve out even further, show a bigger advantage!!

    Mostly I am posting to say you guys aren't running out of options- Syros is going to do a trial with cDK7 inhibitor -faslodex combo, and as you noted there is the Abemaciclib -Keytruda trial, which does have preclinical data saying CDK4,6 inhibitors should make immunotherapy work way better on MBC.I think there are also combos with BET (bromodomain) and HDAC inhibitors, and CDK12 inhibitors should be good, they are not out but making their way through the system (no idea about side effects of these different drugs tho). Hopefully the Alpelisib kicks in and continues to kick butt, because optimism always goes hand in hand with QOL

  • sadiesservant
    sadiesservant Member Posts: 1,875

    Hi Heather,

    How did you manage to get treatment in the US? I live in Victoria and have found it challenging to identify opportunities for trials. We seem to have some similarities - diagnosed originally as stage IIa and I also seem to have a slow growing cancer. The downside of that is that it seems to be resistant to treatment. I'm on my fourth treatment since being diagnosed stage IV in December 2016 (although holding steady with Faslodex for now - thanks for the advice Cure-ious).

    I'm a bit of a "planner" so like to look ahead. Ibrance and my blood did not play nice in the sandbox so we had to stop. Now it doesn't seem to be an option for me. I'm very interested in abemaciclib but, as you know, not available here yet and it doesn't appear that the drug company is any hurry to push for distribution in Canada. With so many treatments under my belt I do worry about being able to qualify for trials should any come available. Seems daft to me - don't know why they care about how many treatments we have had but I'm sure it makes sense from a clinical trial perspective.

    Thanks Susan for all your updates and for pushing the frontiers.

    Pat

  • Daniel86
    Daniel86 Member Posts: 207

    Susan, you go girl for finally getting into the trial.

    Kathy, thank you for the good informed and informative news you bring to the table. Keeps the optimism rolling! Hope its not too hot in Germany atm.

  • marylark
    marylark Member Posts: 159

    Just to add to Cure-ious, my oncologist today told me they are about to start a trial of Immu-132 in HR+ metastatic disease. It got fast tracked in triple negative, due to hit market in January.

  • susaninsf
    susaninsf Member Posts: 1,099

    Heather, Thanks for sending the link. I didn't know that Hope tweeted! Signed up to follow her. I'm on the BYLieve trial: BYLieve. Prefer Phase II trials so I don't have to worry about being on a placebo.

    Cure-ious, Appreciate your update on other new drug types in the pipeline. So happy to see that they are working on more targeted therapies. Hope you're having a fab time in Germany. I'm trying to plan a trip to Berlin. Have been to West side of Germany many times but have a friend who moved to Berlin and others who say its a great international city.

    Pat, So happy to see you (and your beautiful dog) on this thread!

    Daniel86, Thanks for the support!

    Hugs, Susan

  • Sary
    Sary Member Posts: 43

    Susan - I am officially on the trial. Got my first fulvestrant injection (ouch!) and just took my first dose of alpelisib. My doctor was not in favour of taking preventative antihistamines so I will wait and see what happens. Any issues one week in?


  • susaninsf
    susaninsf Member Posts: 1,099

    Congrats Sary!

    Took my 9th dosage this morning. Day 2 I had a trembling hand the but that went away (I think it was because my first and second doses were to close together 15 hours instead of 24). Had some budding mouth sores on day 6 but they went away (I got a prescription for a steroid mouthwash in case they come back). No problems (knock on wood) since then.

    On the positive side, my cough pretty much went away about 5 hours after I took the first dosage. Previously, I was sometimes up in the middle of the night for an hour coughing and spitting up mucous (probably due to progression in my lung mets while I was between treatments).

    Have my next scan on Sept. 17th so we'll see if it's working but I'm quite sure it is! Cautiously optimistic.

    Hugs, Susan

  • newgardener
    newgardener Member Posts: 97

    Congratulations to Sary for starting trial. Susan I’m glad that you are already feeling some good effects.

    Sadieservant - getting into the U.S. trial took some effort (I looked for 18 months) and then some retirement savings. CBCN asked to me to write up my experiences (in 500 words) if you are interested - https://www.cbcn.ca/en/blog/our-stories/Clinical-trial-travel Being in Victoria would make getting to Seattle/the west coast easier. But it can be done:)

    Thank you all for pointing the newer drugs on the horizon. I have next set of scans early next week so it’s always good to know.

    Heather


  • kcan
    kcan Member Posts: 19

    hello everyone,

    I've posted several times regarding my mom's stage 4 tnbc. She was diagnosed stage 4 Aug 30th originally.

    I've pushed to get her into the IMpassion131 trial (atezolizumab and paclitaxel) in toronto. Unfortunately it's phase 3 so there's a 1 in 3 chance we get the placebo. We probably won't start for another month as we have to complete scans, blood work and reconfirm a diagnosis of tnbc. A total of 2 months waiting. This is frightening but rads onc, primary onc, trial onc and naturopath onc say this cancer (based on our scans) is slow growing and she has time to wait. I worry nonetheless.

    Thank you for this great discussion, I'm always looking ahead at the next steps and sometimes the options seem very limited.

    She practices IF beginning at 7pm and breaks fast around 10am the following morning.

    Susanin- so glad you have found some relief quickly. I hope SE are minimal and easy to control.

    Sary- we're neighbours! Congrats on getting into the trial!

    Marylark- we've been very interested in the immu-132 as well as Maraba.

    Peace and strength to all, sorry for the lengthy post.

    Katherine


  • susaninsf
    susaninsf Member Posts: 1,099

    Katherine,

    Thanks for your kind words. Your Mom is very lucky to have you as her advocate.

    Hugs, Susan

  • Sary
    Sary Member Posts: 43

    Hi Susan - Quick question - this morning I noticed red dots on my skin in various places, so I think I am experiencing the rash side effect of alpelisib. Of course, it is a Saturday when the cancer centre is closed! Could you let me know what antihistamine you are taking and in what dosage? I don't want to wait until Monday to start treating this.


    I have generally been well, but it seems like a bunch of side effects hit me yesterday. I guess it is building up in my system now.

  • newgardener
    newgardener Member Posts: 97

    Hi Sary,

    Did you get in contact with someone about the rash? I know that for the clinicaltrial I’m part of in Toronto, they gave me afterhours emergency contact information and told me to not hesitate about contacting them - especially for allergic responses.

    Heather




  • susaninsf
    susaninsf Member Posts: 1,099

    Hi Sary,

    Sorry to hear about your rash. I take a double dosage of Allegra. 24-Hour dosages twice a day. So far no rash but my fatigue has been pretty bad lately. I also have prescription steroid mouthwash to combat any mouth sores but haven’t needed it. In the first couple of days I had some but I used a dental paste for mouth sores and they went away right away.

    Hugs, Susan

  • Sary
    Sary Member Posts: 43

    Thanks to you both. Rash became very wide spread and accompanied by a fever. I was nervous about the fever so went to the ER yesterday. No signs of infection. They gave me a prescription for prednisone and Zantac to take with the over the counter antihistamine. Based on a call with thecancer centre today, I am also pausing the Alpelisib until the rash is under control.