Ibrance/Palbociclib/Pallas trial... experiences?
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At the San Antonio Breast Cancer Symposium in December 2015, they said the PALLAS study begun in October 2015. The trial is about 2 years for each patient. The first five years surviving rate will be in October 2020. But I'm sure there are somewhere preliminary results...
I know that when the preliminary results are good they are communicated to the press.
Lexica, what is the hormone therapy you have with Ibrance? Mine is Faslodex.
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I'm on exemestane (aromasin) + lupron.
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Thank you Lexica.
I decided to read the results of PALOMA 3 in The Lancet because of the lack of information about the PALLAS trial results. PALOMA 3 is designed for patients with stage IV breast cancer using Fulvestrant as hormone therapy.
What I read was really disturbing.
First, the clinical trial was designed not like most of the others. Generally active molecule vs placebo are equally distributed to be 50/50. In this trial there is 25% placebo vs 75% Ibrance.
Second I read this :
- 347 women were assigned to fulvestrant plus Ibrance, 145 progression-free-survival events had occurred
- 174 to fulvestrant plus placebo, 115 progression-free-survival events had occurred
Okay, I learned how to calculate at school so :
- 145/347 for the Fulvestrant plus Ibrance group : 41% of progression-free-survival events
- 115/174 for the Fulvestrant plus placebo group : 66% of progression-free-survival events
WTF, ladies !! Taking Ibrance with Fulvestrant diminish the chance to survive without progression or I'm wrong ?!? What is progression for women in stage III like us: stage IV ?? With all the SE of Ibrance ?!?
And thinking about it, these results are not so illogical because Ibrance put a lot of disturbance in the immune system and the immune system is so important with cancer. So with a very strong hormone therapy like Fulvestrant, these results are logic.
The only difference in favor of Ibrance, is when you are progression free, you have 9.5 months of progression-free-survival events vs 4.6 for Fulvestrant alone. BUT 73% of major SE in the Fulvestrant + Ibrance group vs 22% in the Fulvestrant alone group. And no global surviving enhance in Ibrance + Fulvestrant!
I didn't read the PALOMA 1 and 2 studies so I don't know what really happens for Aromasin, Arimidex or Femara...
I decided for myself: I will not have any Ibrance until I speak to my MO and will do Fulvestrant alone.
To read the study : https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00613-0/fulltext
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Wow, that is interesting. I'm not sure what to think - I know for a lot of stage 4 folks, Ibrance has provided significant reductions in their tumors. This is very surprising.
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For us, stage III, the problem is not the tumor shrinking but preventing the recurrence. And if I read well, for those who get Fulvestrant, the job is better done without the Ibrance. I have no clue about the AI you are on, Lexica because I didn't read Paloma 1 and 2...
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One year has past... I am half way through... Doing ok. How are you doing...everyone?? I am Wonder h when there will be some «early results» of this trial...
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Hi Anna,
Congratulations on finishing year 1. Glad you’re doing okay. I am too. Just starting cycle 16 at 100 mg. They lowered my dose last month due to low neutrophils. I don’t have any intell regarding results. Possibly not until 2020.
Notma
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I started cycle 9 today. I am still on 125 mg of Ibriance and go every 3 months for my check ups and to get the medication. The oncologist did mention today that they closed the study, and we should start hearing some early results soon. She also mentioned that there are a lot of new trials coming out that are working on the same premise as Pallus Trial, but with different medications, one of them was keytruda (spelling??) I think,
Side effects are minimal, but the appointments are time consuming.
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Good to hear from everyone and congrats on hitting the year one mark. I am almost there - I will hit one year on Ibrance in April. Hair is thinning, and I have extreme dry eye and migraines, but who knows what is causing all that. I did get the iRestore helmet thing for the thinning hair. One of the ladies on the Thinning Hair thread suggested it - hoping that starts making a difference!
I wonder with the other trials if you would be able to enter having already done the PALLAS? I feel like most trials have previous 'experimental' treatments as an exclusion criterion.
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How is everyone doing?
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Thanks for asking Lexia. I am doing ok. Do not know what sideeffects that are from the Ibrance and what that is from other treatments. Slow growing eyebrows is one thing I belive is from Ibrance... I am SO curious about when to expect preliminary results from this trial. Wish more trialmembers Foundation this group..
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I agree - I know they've cut out asking about a lot of the side effects, so I know they have some results.
That's a bummer about the eyebrows. I am really hoping the hair loss is at least partly due to Ibrance, too. I am back to wearing a wig! Although my 3 & 5 year old can't ever tell if I'm wearing it or not, so maybe I'm making more of this issue than need be, lol.
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I know that when I went for my 3 months in February, I didn’t have to fill out the paperwork that I normally have, about quality of life. I did notice a difference in November when I didn’t take the ibrance, (due to surgery) and was only taking the letrazole. So far it’s manageable side effects, but will be happy when my 24 months is up.
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Paperwork? I have never filled out anything. I have ten cycles left.
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Anna, you don't fill out the questionnaires about side effects and if you've taken your meds? That doesn't seem right...?
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The only paperwork I do is the one where I wrote what medicine, dose and the time. Nothing about sideeffects...
Increased pimpels after treatment anyone
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That is odd. I have to fill out a couple of forms every time I see the onc about tiredness, have I taken my pills, etc. No issues with pimples so far. I did start getting mouth sores though.
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I still have the daily diary for the ibriance and letrazole that I fill out and return with my empty pill bottles. Before this last appointment, while waiting for them to fill my medication, I had a packet to fill out asking about any side effects and quality of life. (Hot flashes, tiredness, any pain). This was the 1 st time I didn’t have to fill that out. I go back in May and will see
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My oncologist set me up with a specialty pharmacy for my Ibrance. No forms or questionnaire to fill out. I am also on letrazole filled by my local drug store.
Before the order is set, I get a call with questions, side effects, taking my other meds,is the medical working for me, etc, nothing unusual.
I have been on ibriance and letrazole for 18 months now.
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Hello ladies, stopping in because I just started Faslodex and Ibrance as part of my regular treatment after a recurrence on Aromasin. I was wondering for those of you who have been on Ibrance for quite some time (over six months) if you had hair thinning or loss. When I was first diagnosed I could have cared less about hair. I just wanted to be 'cured'. But now that I have lost my hair and grown it back even thicker and more luxurious than before, I'm like "hold up, is this medicine gonna make me lose my hair again". I know itt's ultimately silly to be worried about balding when you are trying to beat the beast, but nothing about cancer makes sense right? Anyway, would love to know if anyone has had any significant hair loss on Ibrance.
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I have used Ibrance for over a year. One period (arond cycle 8 If I remember right) my hair started tinning... just tiny so only I noticed... But it stopped again and got normal again. My sideeffects are low white bloodcounts... Good luck!
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Thanks Anna! I'll take that luck. Glad you are doing relatively well on Ibrance
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Hi All. Responding to Opt4Life ... I started Ibrance shortly after finishing chemo. My hair had returned very nicely after chemo (just as thick as before and a bit less gray). After almost 17 cycles of Ibrance/Anastrozole on the Pallas trial, my hair has thinned a lot. Sad, but true! -- Peggy
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Opt4Life
I have been on IBrance for 18 months... I had long, thick hair... Until I started the meds... I would find my hairbrush filled with hair... and hair just falling out all over the place... It turned very brittle, dry and unmanageable. Feels weird feeling thin hair on my scalp.. Not what I have been use to all my life... Today, I decided to get a haircut, Like Helen Mirren...never had hair this short... But you know what, I like it so far...
So don't worry about hair thinning, remind yourself it could be worse....
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It's so quiet here. Are you okay? I have 5-6 cycles left I think. My side effects are neutropenia and very tired day 22 ... ie when the break started. How do you experience side effects? I wonder how everyone is doing ... and what's going on ... Wondering if anyone has relapsed during the study and so on ... Hope really everyone is fine.
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Hi, Anna. I've been thinking about posting here recently, too - you're right, it has been quiet! I'm doing okay - I'm on an Ibrance break now because I had my reconstructive surgery two weeks ago. I should go back on it in the next week. I can't say I feel any different since I've been off of it (only 3 weeks), definitely no improvement in the fatigue. Although, I swear I am getting the 'peach fuzz' on my face like I did after I stopped chemo. It makes me hopeful that when I do go off of Ibrance, the hair on my head will come back a bit! I am wearing a wig over my hair and blending it right now because I have bald spots - enough to be noticed unfortunately.
How have you been?
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Good to hear that things are going well with you! I wish we could include more actively in this thread .... but don't know how we can reach out. There probably are many of us ... We keep in touch!
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Hi All. I too am still on the Pallas trial. I just started cycle 22 @ 100 mg. My neutrophils continue to be very low. I have noticed more fatigue lately. My 15-3 tumor marker is a bit elevated at 33, which I don’t like at all. I’m starting to think about what next after the trial ends.
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I have 6 cycles left and also have started to think about «what after?»... The Ibrance has felt lik an insurance for these first years... The massive metastasis in my nodes are terrifying..
Not Margaret ... I hope your elevated marker is just due to the unormal bloodcounts...
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I have a lot of positive nodes too. I am considering the Care Oncology protocol for afterwards.
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