Denosumab as Adjuvant Treatment

Tazzy

After diagnosis I was offered the chance to be part of clinical trials for Denosumab by my MO.   After lots of research and considerations with my hubby decided to be included in the trials.   So far I have had 3 injections - no SE's to the best of my knowledge... but still on chemo so dealing wtih those SE's.

Just wondering if anyone else out there is part of the these trials and if and what your thoughts are so far.

sbelizabeth

Hi, Tazzy.  I joined the denosumab clinical trial and had my first injection the day after my first chemo, which was December 15, 2011.  Of course, it's a double-blinded study, so no one knows if we're getting the drug or the placebo, but based on the fact that the injection stings pretty good, I would bet that I'm receiving the drug itself.

Each day I got a denosumab shot I also got a Neulasta shot, and both of them are known to produce aches and pains.  So is the chemo, so I couldn't tell you which drugs caused each specific owie!

Now that chemo is finished, I'll get my next denosumab shot in July.  Blessings to you!

Jennt28

I'm also on the D-Care trial (since January). I have been doing weekly Taxol/Herceptin with the trial shot every 3 weeks. On the week I get the trial shot I ache so much worse afterwards than the other weeks...



I have now finished the 3 weekly shots and am moving to 3 monthly ones.



Jenn

Tazzy

Hi Ladies, thanks for getting back to me.

I move to the 3 monthly shot after last chemo treatment on June 22 (woohoo!).   Apart from Taxotere, Dexamethasone, Neupogen I am not on anything else other than denosumab. 

Good to connect to see what I can/might expect afterwards... but as you say its a double blind trial so who knows.... ?

Sbelizabeth... will be good to hear back from you in july after your shot to see if you suffered any adverse SE's. 

hope you are both having a great day!

Robyn_S

Hello ladies! I am in the DCare study as well since May 2011. Being a double blind trial i don't know if I am getting denosumab or the placebo. What I do know is that the syringe contents does not look like saline at all to me so would make an educated guess that I am on the active arm. I have not had any side effects at all and have just had my CAT and bone scan. Being monitored is the main bonus for me as being stage 3 I am anxious about any progression since finishing treatment in October, although still on tamoxifen. I will get the results (hopefully all clear!) in 3 weeks when I get my next shot.

My main reason for enrolling in the trial is the thought that all the cancer treatments that I have had have been tested for safety and efficacy by brave women fighting this horrible disease before me. It is nice to have a chance to give back in appreciation for having the benefit of safe and effective treatment today.

Cheers Robyn

Jennt28

Hi Robyn, We are the same age it seems :-) And same age at diagnosis...



I signed up for the same reason as you. Also want to do everything I can too avoid the cancer coming back or at least to catch it early if it does.



Jenn

Tazzy

Good luck with the scan results Robyn_S.  Keep us posted eh?  

I was told that the only way we will ever find out if we received the actual drug or a placebo is if it proves to be a success and will go on the market for this reason - they will unblind us all.  

I had the MRI/Bone/CT scans just after diagnosis due to the aggressiveness of the cancer - thankfully they all came back clear(ish).   Couple of 'blips' on my adrenal gland and lung... which all have assured me were benign.... plus the chemo I have since received should've zapped them.

That was the reason I signed up too.... apart from the monitoring we receive, its the giving back and hopefully helping others down the line who get this horrible disease.

Enjoy your day ladies !

sduch1

I am also part of the D-Care trial. I have received 2 shots so far while also getting my neo-adjuvant Taxol/Herceptin. I have not noticed any significant side effects. I haven't really looked at the contents of the syringe. If it didn't look like saline, what did it look like? Just curious for next time I go in....

Tazzy

Hi sduch1... welcome !   My shot just looks clear - like my neupogen shot... just more of it.  

Jennt28

You shouldn't see a difference, that's the whole idea of blinded trials. The denosumab and placebo are both clear with no colour.



Um, there is a trait of denosumab that is harder to disguise... It is thicker in consistency to saline so harder to "push" and therefore more likely to cause pain going into the tissue. The difference is minor though and could be very hard to pick up.



In my case I suspect I am getting denosumab based on SEs but the human brain is a funny thing and so I could be completely wrong and it's just a "placebo effect".



Jenn

Chickadee

Just curious. Denosumab is marketed as Prolia and Xgeva and FDA approved. Lots of us have been getting Xgeva shots for sometime. What is this trial seeking to find?

Always something new to learn.

Jennt28

It's studying if it can be used as adjuvant treatment in early stage BC women to reduce the number of those women that go on to develop bone mets despite surgery, chemo and rads.



Looking at safety as well...



Jenn

Chickadee

Thanks. Very cool.

Robyn_S

I suspect that I am receiving the active arm, I have noticed is that the injection solution i have received has a very slight yellowish tinge to it and when drawn from the vial will be a bit foamy (i suspect due to dissolved proteins) compared to saline solution which is always a 'flat' salt solution and completely clear like water.

I honestly like to think that after all the treatment over the past year that this little extra will make no difference as I am already completely cured!!! positive thinking!!!

Tazzy

Not sure about any SE's with me and denosumab.  I am still on chemo and neupogen - so getting bone aches and pains from that.   I am going to take more notice of the consistency of the shot next Friday when I am due #4.

Robyn_S... you can't beat the power of positive thinking.... better than the negative eh?   I like to think I am receiving the active arm also.... I mean I was the first one in my region to be signed up for the trial

Robyn_S

Hello everyone! I had my DCare scans last week and got results of my CT - turns out that I have a pulmonary embolism - symptomless as i felt fine but as I have had major surgery 4 weeks ago (bilateral DIEP) and am on tamoxifen -clots not totally unusual. I will need to self inject clexane for a while until it resolves and the onto warfarin for a lot longer. More worrying is a spot on my lung...that was not there a year ago. At least my bone scan must be okay as I have not heard anything !!

If not for being on the study I would be oblivious - sometimes ignorance is a lot more relaxing!!! Maybe there is a downside to extra tests and scans!

In need of a big boost of positive thinking!!

Jennt28

Hi Robyn,



Damned if we do and damned if we don't I guess... Are they going to follow-up the lung spot? Did you have rads that could have caused it (fibrosis)?



I thought we just got the bone scan for the trial...



Jenn

Tazzy

Hi Robyn,

Positive vibes coming your way. 

Ignorance is bliss eh?  Or so they say.  

Stay strong and positive - we are alll with you.   Keep us posted on how you are doing.

Take care and have wonderful days ladies.

sbelizabeth

Well, girls, I'm out of the club.  Because my oncologists are going off the grid with varying from standard treatment, I've been tossed out of the denosumab trial.  Darn.

So they wanted to draw a final set of labs and I said OK, so there I sat in the infusion room, surrounded by a crowd of infusee's.  Men and women. The research coordinator is (loudly) questioning me.  When was my last CT scan?  When was my last bone scan?  When was my last mammogram?

Something snapped.  I said, just as loudly, "I DO NOT HAVE A BREAST."  

So now I'm really pissed that once again, I let myself answer an inappropriate question just because someone asked it.  NEVER AGAIN. 

Thank you, that little rant felt good. 

Tazzy

selizabeth... they kicked you off cos of your answer ?  Isn't there someone higher up you can write to.  Sounds like she was more inappropriate than your answer.  
That is so bloody wrong... rant ahead. 

That just sux.

Jennt28

Which standard treatment is being varied? I thought the protocol wasn't that specific about what treatment...



Jenn

sbelizabeth

Tazzy, they didn't kick me out because of my answer.  The research coordinator was asking these questions as standard protocol when someone exits the study.  They also want an exit CT scan of chest, abdomen and pelvis, along with a bone scan, but I think I'll tell them they can wait until my oncologist orders them as part of my standard follow-up.  I have had ENOUGH RADIATION in the past month to light up New York, and I'm not going to glow even brighter just to satisfy their exit-study protocol.

My cancer is weird and hasn't behaved like one would expect it to, so after radiation is finished, they're empirically adding four rounds of Xeloda/Navelbine.  I don't have mets, but they want to open the whole can of whoop-ass on this thing the first time around.  The extra chemo is what's eliminating me from the study.

Oh, well.  I had a 50% chance of just getting saline anyway!

The study coordinator actually called to tell me to mail the calcium and Vitamin D back to her.  Unbelievable.  If I were to actually do that, would they give the pills to someone else?  Are the pills I have recycled from some other woman who exited the study? 

Tazzy

Thanks for clarifying selizabeth.  I am blaming chemo brain on my misunderstanding  

I cannot believe she asked you to return the vitamins to her... WTF ???  Really - that is unreal.

Sorry you have to more chemo - that's the pill type eh?  Fingers and toes crossed it kicks your cancer into touch.

Take care xx

Jennt28

The supplements thing is weird... and, in my life outside BC I am a Clinical Trial Coordinator! We do ask that patients return medication tablets (oral chemo tablets) but would not ask for supplements to be returned - especially at YOUR expense.



Jenn

Racy

I just read the article that cp418 posted on the study about beta blockers and denosumab and my further researching led me to this thread.



I am interested in this trial and will investigate eligibility.

Tazzy

Let us know how you get on.   

I finished chemo on June 22 and had the trial drug administered then... still hard to tell if I am getting any SE's from the trial drug, if indeed it is the drug and not placebo.    Next shot is October 4.

Jennt28

I'm now into the 3 monthly shots... Next one is in two weeks. Everyone (study nurse etc) seemed to think I was getting the drug but last time they checked my calcium levels they had gone up over the normal range (hypercalcaemic) so my onc had me stop the calcium supplement but still take vit D. I'm now thinking that my calcium going up so much probably means I'm getting the placebo... darn!



Racy - it's called the D-Care trial and if you do a Google search you will find lots of information. I think you may be outside of the starting time-frame though. Worth a check though!



Jenn

Tazzy

Jenn - darn it if you are... I think we are all hoping to have the real drug eh?   Will be interesting to see what  my next blood work says too.  I'll keep you posted.  Let us know what your results are next time.  

I do know that they are still taking people here in BC, Canada for the trial.  Not sure what the 'closing' date is though.

IamPam

I am in the denosumab trial and had my first injection sept 30, 2011. I usually have deep bone pain in my sternum, low back and pelvic bones that lasts for 3-4 days after the injection. At first I thought it was from the neulasta injections after chemo. But my last neulasta injection was January 6, 2012. I still get deep bone aches and pain for a few days after denosumab. Hopefully that is a good sign.

I do have a question though. I have had two PET scans since finishing chemo. Both "light up like a Christmas tree" (according to my oncologist). Does anyone know if denosumab injections can cause increased activity and uptake in the PET scans?

kcscarlett

Diagnosed 3/15 - stage 2.5 HR+. Qualified and completed a successful clinical trial Oct. 2015 w/letrozole/buparlisip. Pretty sure I got the real deal as SE were significant and results were very good as tumor was greatly reduced. Surgery (partial mast) 11/2016 followed by 6 weeks radiation. Oncologist now is encouraging Denosumab for all the obvious reasons w/HR+ & letrozole. Curious as to others experiences related to this combined treatment. Thanks

Moderators

Hi Kscarlett-

Welcome to BCO! This is an older topic which hasn't been active in over 4 years, so it's unlikely you'll get much feedback from the original participants. We recommend starting your own topic and opening it up to the community. For help on how to do that, please refer to our Help section.

Thanks!

The Mods