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Ibrance/Palbociclib/Pallas trial... experiences?

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  • mikamika
    mikamika Member Posts: 242
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    Anna-33,

    PENELOPE-B trial is done after surgery. 13 cycles of Ibrance+AI or AI alone.


  • beeline
    beeline Member Posts: 193
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    Lexica, this probably doesn't help much but like MikaMika was saying about higher risk patients showing benefits, when I was trying to get into the Monarch-E trial (a similar cdk4/6 trial for early BC) my MO said that Pallas was unlikely to get statistically significant results because its participant pool was so wide, including many with lower risk Stage 2 BC. Monarch-E was stricter in terms of high risk patients, so he thought it would be more likely to show statistically significant results. It is also possible that when they analyse the data in groups based on risk/stage/etc. we will see better results for those of us with higher risk. Of course I ended up on the control arm so it won't do me any good anyway, but I have high hopes that there is something more for us out there and cdk4/6s could still be that something!


  • kaffern
    kaffern Member Posts: 3
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    I'd like to introduce myself. I just read through everyone's posts as I, too received this very disappointing news just today. I was on the PALLAS trial too -completed it end of April 2020. I just came from the final checkup yesterday already dealing with ongoing hormonal treatment decision issues. And now this. It felt like I had achieved something in completing that trial, but then received a very dispassionate and upsetting call from my MO.

    This is so hard. I hang on to what beeline's MO said: "my MO said that Pallas was unlikely to get statistically significant results because its participant pool was so wide" as a bit of hope that the trouble and fuss of this trial were not all for nothing!

  • mikamika
    mikamika Member Posts: 242
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    Kaffern,

    I'm sorry about the news. How was your experience with Ibrance? How you tolerated it?

    Ladies, you did it! You went through the trial! Please, please don't allow your mind to dwell on the negative aspects! Just believe that in your case this drug has made a difference.


  • HOPE012119
    HOPE012119 Member Posts: 19
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    I am so grateful to you all for doing the Pallas trial!! I'm in awe! I'm not even done my first year with the Natalee trial (ribociclib). Thank you! You led the way!

    There's so much to learn! The treatment could have helped you more than folks know right now. And the pool was wide from what I've read.

    (Sorry if I posted this twice. Had some trouble)

  • lexica
    lexica Member Posts: 138
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    Welcome Kaffern. I see we were diagnosed around the same time.

    Sorry - I know this just sucks. I wasn't able to find an info on the higher risk groups after a quick search, but like beeline said, hopefully with time they will be able to provide some details on different risk groups.

    Thanks for the positive, Mika - you are definitely right - we did it, and it helped the world find the answer to a question :)

    After my treatment ended in 2018, I paid for one of those CTC tests (from Biocept). I got a negative result; that along with taking Ibrance kind of quelled my fears about recurrence - not totally of course, but some. I think I am going to go ahead and do that again since it has been 2 years. I just have to talk my husband in to spending the money, lol.

  • beeline
    beeline Member Posts: 193
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    Lexica, can you tell me more about the CTC test? Was it through your MO? How much did it cost? I like the idea, though I'm not sure I would want to know if it came back positive.....

    I did a little more digging around about the Pallas trial announcement and found this:

    investors will have to pin their hopes on another trial—dubbed Penelope-B—testing the drug in patients with a high risk of recurrence after pre-surgery chemo. That study, which began enrolling patients about two years earlier than Pallas, is still ongoing, Stanicky noted, adding that "in theory, we would expect more events to have occurred in the higher-risk patient subgroup," indicating that trial may be going better.

    https://www.fiercepharma.com/pharma/pfizer-s-ibrance-misses-shot-at-big-new-market-early-breast-cancer-failure

    But what felt really clear to me the more I read is that this is purely a financial evaluation. It seems Pfizer used such a wide pool in hopes of capturing a larger market if it worked, so all of these articles calling it a "failure" are really just saying that Pfizer isn't going to get the giant market of ALL early BC patients. I think when we start to see the academic data it will tell us a lot more, and I think it will show a benefit. Either way, I agree you should definitely congratulate yourself either way for participating in the trial!

  • anna-33
    anna-33 Member Posts: 108
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    @beeline Thank you for explaining! I hope you are right!

    Both the studycoordinator and my MO have asked for a talk.

    Let us share all information with eachother..

  • notmargaret
    notmargaret Member Posts: 28
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    Hi All. I’m meeting with my oncologist next week and will report back re Pallas. I remain hopeful that the subset analysis will show that the Ibrance helped some of us.

  • kaffern
    kaffern Member Posts: 3
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    Thank you MikaMika - that is encouraging for me! You are right!.

    Ibrance was ok - one serious infection incident after a flu this winter and a scare with that interstitial lung disease that likely wasn't, but my main issue has been the up and down with muscle weakness and joint pain with the AIs. I am now wondering if this was just made worse by the 21-day Ibrance cycle. I have just had a quite a bad time with it all through May, right after the trial was completed. I am wondering if this was related to Ibrance. Things seem to be improving now.

    Yes, Lexia, similar diagnosis and timing. I was on exemestane until I could not tolerate it, then after a break, I started letrozole. Not much difference, although I have some hope going forward.

    So interesting that article, beeline - and yes Anna and notmargaret, I am keen to hear more about what that futility threshold implies.

  • lexica
    lexica Member Posts: 138
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    Thanks beeline. That's some good information. I did find that most of the 'news' about PALLAS was financially related... a bit irritating. Definitely looking forward to the Penelope results!

    Yes, Anna - I will definitely share. I see my trial MO on the 19th.

    More about the CTC test... it was ~$500 from Biocept when I purchased it in 2018. It was fairly easy, although, my MO couldn't order it because of the insurance I am under, I had to place the order and get him to sign off on it. I received the kit, got my blood drawn and sent it out the same day. Got results back in a couple weeks. Mine came back negative, thankfully, but I share the same fear, beeline. From this study, the negative predictive value of 98% is what sold me. If it comes back negative, you're likely to have 2 years worry free (ha-ha). I didn't have two years worry free, but it did help when my mind started to go to the dark places.

    "Positive CTC results led to a predictive value for recurrence of 35% at 2 years in the HR-positive population, while negative results had a predictive value of 98% for this group. The recurrence rate per person-year was 24.7% for patients who had positive CTCs and 1.5% for patients with negative CTCs."

    My MO did mention that the ctDNA test was a bit more sensitive, so I am considering doing that this time around with this company.

  • BlueGirlRedState
    BlueGirlRedState Member Posts: 900
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    I was trying to read up on the PALLAS and trying to understand what it was measuring. This is the 3 round of BC for me, twice on the left, and now on the right (after a bi-lateral and chemo). Oncologist thinks each is a new occurrence rather than recurrence, but when pressed, admits there is no way to really know. I started Ibrance Sept 2019, and so far it seems to be working. Tumor shrank from 2.3cm to 7 mm April 2020. Hoping it shrinks into oblivion. But will it be a "forever" drug? I hope not. I want my energy back.

    2009 ER+ left breast. 52 yrs. Lumpectomy, Sentinel node removal, negative. Radiation 6 weeks, tamoxifen 5 years. Dense lumpy left breast, normal right

    2016 ER+ left breast. Probably a new cancer, but unknown. 4 rounds TC Aug-Oct 2016, Bi-lateral (my choice) Nov 2016, no reconstruction. 2 sentinel nodes remove, negative. Cold Capping using Chemo Cold Caps (DIGNICAP not available). Anastrozole 1 mg starting May 2017. Joint issues noticed immediately. Stopped Anastrozole after 3-4 months due to joint stiffness in. After several months of no AIs, fingers were feeling better. Started tamoxifen March 2018.

    6//2019 Noticed Swelling in R-arm, opposite side from where lymph nodes removed Urgent care checked for clot, found lots of fluid, and told me to see my doctor. She referred me to lymphatic therapist, who thought something was very wrong since it was contralateral.

    Aug/Sept 2019 more tests, scans, biopsy. Cancer found R-axilla. Ibrance and Arimidex prescribed.

  • anna-33
    anna-33 Member Posts: 108
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    I have met my MO today. She said the PALLAS trial is stopped in form of they that are on the Ibrance now (in the trial) are told to stop. It has been two different analysis of the results.So disapointed:( even thoug I finished all the cycles. She also said they had gone all in for the cdk4/6-inhibitators...so for now there are no new meds coming up for hormonsensitive bc.

    Still hope there are differents between subgroup.

    It is so hard to be on high risk when you have small kids

  • mikamika
    mikamika Member Posts: 242
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    Anna-33,

    Thank you so much for keeping us updated! Did your MO give some information about those two analysis? What was her personal opinion?

    Without Ibrance your treatment would have been just AI, right? So you did everything possible to lower your risk!


  • batsy
    batsy Member Posts: 5
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    Hi wonderfuls,

    Just heard from Dr Lin at Dana-Farber. The trial failure was based on 3-year results that seem to show no benefit and no harm. She hopes there may be some benefit seen for cancer subsets at five years. Good news is that if any of us progress to Stage 4 we're still eligible for CDK 4/6 inhibitors, since they now clearly work differently in the metastatic setting. So no more Ibrance from today--now I can figure out what side effects are from Ibrance and what's the letrozole :)

    Sarah

  • beeline
    beeline Member Posts: 193
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    Thanks so much for sharing this, Sarah!

  • BlueGirlRedState
    BlueGirlRedState Member Posts: 900
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    Batsy - I was trying to find out more information on trial like Pallus, if/how Ibrance is used in non-metastatic. So far it seems to be working for me, if tumor size is a good measure of success. This is the 3rd time BC, twice left, and now right. Oncologist thinks each is a new occurence, but admits there is no way of knowing since cancer mutates so much. Started Ibrance Sept 2019, tumor 2.5 cm. April scan showed it to be 7 mm. No evidence of metastasis based on Sept 2019 PET

    2009 ER+ left breast. 52 yrs. Lumpectomy, Sentinel node removal, negative. Radiation 6 weeks, tamoxifen 5 years. Dense lumpy left breast, normal right.

    2016 ER+ left breast. 4 rounds TC Aug-Oct 2016, Bi-lateral (my choice) Nov 2016, no reconstruction. 2 sentinel nodes remove, negative. Anastrozole. Joint issues noticed immediately. Stopped Anastrozole after 3-4 months due to joint stiffness in. After several months of no AIs, fingers were feeling better. Started tamoxifen March 2018

    6/18/2019 Noticed Swelling in R-arm, opposite side from where lymph nodes removed. 7/2/2019 lymphatic therapist recognized that there was something very wrong and sent me back to the DR.

    8/2019 CT, Breast/chest, neck/thyroid ultra sound

    9/2019 DR ordered biopsy, said it could be lymphoma, cancer, benign lymphatic. Biopsy R-axilla. Cancer. Genetic test showed no known markers (20+ looked for). 9/29/2019 PET scan, no indication of spread. Arimidex and Ibrance prescribed to shrink tumor prior to surgery, if needed. 2.5 cm tumor

    1/2020 CT scan tumor shrunk from 2.5 cm to 1.1 cm

    4/2020 CT scan showed tumor shrunk to 7 mm

  • mikamika
    mikamika Member Posts: 242
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    BlueGirlRedState,

    May I ask you a few questions?

    Did your 8/2019 CT scan show something in your axilla? What are your SEs on Ibrance?


  • kaffern
    kaffern Member Posts: 3
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    HI Sarah:

    Thank you for that info - I am there too. Sorting out Letrozole from Ibrance side-effects.....

  • lexica
    lexica Member Posts: 138
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    Yes, Batsy and Kaffern! Really hoping this hair loss was due to Ibrance - although I think I'll be disappointed. They should come up with an extension of the study that asks that question specifically. I think it's a rather unanswered question...

  • notmargaret
    notmargaret Member Posts: 28
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    Hi All,

    I met with my oncologist. Not much additional to report. He indicated that the Pallas result was a surprise to the researchers. He echoed what we’ve all seen about needing more data about the various subgroups. He mentined that the fact that most of the Pallas participants had had chemo might be relevant. Penelope results should be out later this year

    I’m with you on the hair issue. My hair thinned during Pallas too, but stopped. It also is growing at a snail’s pace. I’ve been off Pallas for 6 months now.

    My doc was pleased with the rebound in my bloodwork numbers. I hope you’re all rebounding well too.

    Notm

  • BlueGirlRedState
    BlueGirlRedState Member Posts: 900
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    MikaMika - SEs and Ibrance. Fatigue is the big one for me, sometimes mild other times not. Usually I can push through it. Sometimes achey thighs as if I had done a heavy workout/hike, when I have not. Take 400 mg magnesium glycinate daily, I think it helps. Sometimes mouth sores. Salt rinse gargles seem to alleviate/get rid of them. I should probably do these daily rather than as a response when I start getting them. I mentioned hair thinning to MO, and she suspects it is the Arimidex rather than Ibrance.

    PET scan Sept 2019 showed no metastasis. Started Ibrance and brand name Arimidex(Anastrozole) Sept 2019. The scans July - Sept were the first I had had since the 2016 diagnosis. No mamos since no boobs. It has been one of my frustrations that monitoring is minimal outside of mamos. MO said there is a reluctance to expose to unnecessary radiation with other scans, also insurance would probably not pay. Hoping next CT (Aug ?) will show tumor has shrunk even more, maybe into oblivion.

  • notmargaret
    notmargaret Member Posts: 28
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    Hi All,

    A couple questions:


    1) Did you see the positive results for the Verzenio/Monarch E trial? They show significant reduction in recurrence for high risk early stagers taking an AI plus Abemiciclib (Verzenio), another CDK 4/6, vs. the control arm at three years. I would be interested to know what the experts think about what this means for Palbo. Was it the different drug or was it the higher risk population vs the Pallas population. If anyone is meeting with their MO it would be great to hear about the thinking. Unfortunately I met with mine two weeks ago.


    2) Has anyone had a Guardant360 test?

    Notmargaret



  • beeline
    beeline Member Posts: 193
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    notmargaret, I'm interested in this, too. I see my MO in about 3 weeks and will ask him then. I've already emailed to ask if the results mean I can get verzenio (I got randomised to the control arm on MonarchE).

  • kmom57
    kmom57 Member Posts: 177
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    I asked. My MO said it could be the higher risk population, but until we see all the actual numbers, there’s no way to know. He said until all the data is out there, we can’t know how or if it impacts treatment. Said by the time I finish chemo (fall) we should know more definitively what it means in practical application.

  • lexica
    lexica Member Posts: 138
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    Thanks, KMom. My MO said things along the same lines. She also pointed out that this finding could lead to more findings...if that makes sense. I think everyone expected this to work, and the fact that it maybe didn't work how we expected tells us something and will hopefully lead to more progress. She compared it to when the first started with the AIs...there was a study that combined Tamoxifen and an AI and everyone was convinced "1+1 would equal 3." But it didn't, and now they understand why.

  • anna-33
    anna-33 Member Posts: 108
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    Good News!!! The other similar trial Monarch (I belive thats the name) shows 25% less chance of recurrence after ising CDK4 inhibitators... AND it is said that the «failure» of Pallas probably is a result of:

    1) 40% (!!!!) stopped taking the meds during the trial.

    2) Pallas included lots of people with very early stage that probably would not get a recurrence anyway..

  • lexica
    lexica Member Posts: 138
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    Hi, Anna - I saw that... was trying to make sense of why one CDK4/6 would work and not the other... Good to hear from you! I was thinking about the ladies on this thread lately. Hope everyone is doing well!

  • notmargaret
    notmargaret Member Posts: 28
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    Thanks for the good news, Anna! Nice to see you and Lexica pop up. It will be interesting to see what comes out of the San Antonio conference in a few weeks.

  • anna-33
    anna-33 Member Posts: 108
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    Lexica and Notmaragaret ... lets stay in touch in this forum, and Please keep me updated if you see any News from the SAN Antonio conference...