Happy Friday, everyone!! It’s a beautiful day to be alive!!!
Has anyone here been offered this trial?
I’ve been on letrozole, Ibrance and Xgeva for a year and it appears it’s not doing its job any longer. I will know more after scans next week.
If not, are you on a clinical trial? I’m feeling like it’s too soon for a clinical trial and that there may be another alternative for treatment that works. I have no mutations.
Thank you. I’m at a bit of a loss as to what to do.
Jody
Good luck with your scans next week. My second line of treatment was a trial and my third line of treatment will be a trial. My neighbor who had multiple myeloma swore the reason he lived 15 years was due to all the trials in which he participated. A Breast Cancer Oncologist noted on a Living with Breast Cancer presentation that "Women who avail themselves of trials tend to live longer". It is never too early. My fear is being too late. You are even more closely followed on a trial, have access to top researchers and cutting edge treatments. Wishing you continued treatment success.
Thank you so much! I feel so much better!! This will really help me with my decision. All this is so overwhelming!! I read all the time and, after a while, everything all blends into a blur!!
I wish you continued success with your treatment, as well!! 💗
Letrazole didn’t work for me either. I wasn’t on it for more than half a year from memory but my next treatment was Abraxane because the bone mets were moving north very aggressively.
I missed out on a trial for Verzenio but my third line was Afinitor and Aromasin. That was in 2016 and I’m still on Aromasin. Early failure doesn’t necessarily mean that your next drug won’t be effective for many years and hopefully that’s the case for you whether it’s a trial or not. Generally you stay on a trial drug for as long as it works as I understand it.
The doctor who interviewed me for admission to the clinic advised me about the trial and he said that the monitoring received in a trial was much better than what is done in general so I definitely concur with Best521 even though ultimately I wasn’t able to go on the trial. Although to be honest, I’ve been more than satisfied with the level of monitoring I get. It’s been reduced to every six months but the March scan concerned the radiologist so a follow up was ordered for May and that was ok. The only thing is that with a trial you usually get genomic testing which in Australia means sending a biopsy to America and the cost is about $7,000 I think (with the current exchange rate it’s probably closer to $10,000 at the moment!) and I would have gotten that done for free if I’d been willing to wait for six weeks. At the time I decided that a bird in the hand was worth two in the bush and I’d rather start a new treatment straight away after Abraxane. As it happened that trial was a Pik3a trial and it was a bust anyway so I only missed out on finding out what my tumour mutations are. I checked your trial name and I’m not eligible for it anyway!
If you do decide to do the trial Jody then let me thank you in advance. All those people who choose to take the drugs that very few others have are heroes to those of us who can’t or won’t for whatever reason. 🫶 Although I would go on a trial, I’ve been told I’m ineligible for most now because of the treatment path I have taken. There’s very few done at my clinic anyway. The last one was in 2015 as far as I know.
All the best
Kerry
Thank you so much for this information!! I appreciate your response and I’m praying you will continue on a path for continued success in your treatment, as well!! ♥️
CT Girl, i think trials are a good choice . At a certain point if a patient has had too many lines of treatment they aren't eligible for trials . That said, I would want new genomic testing done to rule out any newly acquired mutations. Has your oncologist talked about a new biopsy or does that happen as part of the trial ?
The trial covers everything, including genomic testing. I’m doing a lot of reading. Yale gave me a ton of information on it. Thank you for reaching out!!
I did a trial for my second line after Ibrance/Letrozole failed. I was only on it for 6 months before progression but it was an easy treatment and the other options are all still available afterwards. Definitely worth thinking about.
Jackie x
Hi Jody, it’s good that you’re reaching out and asking this question because opinions and experiences with clinical trials can vary. I’ll just share my thoughts based on our experience.
If there’s an FDA approved treatment that your oncologist (and you) feel you would be a good candidate for, that’s almost always the best and most predictable route. If the remaining FDA approved treatments are not a good fit for you due to lack of efficacy for your particular cancer or due to intolerable side effects and quality of life issues, thats usually when trials come into play.
However, there are a few things I would suggest you just keep in mind. Getting into trials can be difficult. It takes time. They need to normalize all participants so they may need to do additional testing you may not have had in the past (i.e: genomic profiling, additional scans, etc). This generally can’t be done by your oncologist, you need to go to the nearest trial sponsor location, which may not be close.
Additionally, a challenge that we encountered was the need to establish “measurable disease”. There are formal guidelines that define measurable disease (tumor size, etc), and this is necessary so they can monitor efficacy. My wife’s cancer had spread to the lining of her lungs and her bones. This did not meet the measurable disease requirements. The cancer in the lining of her lungs could not be measured and they would not accept analyses of her pleural effusions. They also required “tissue” samples of tumors that met the sizing requirements. While bone is technically considered to be tissue they would not accept a bone biopsy, they insisted on soft tissue. So while we were having supplemental scans at the trial sponsors request we found that her cancer had spread to her liver. We were able to get a biopsy of a tumor in her liver that barely met the sizing requirements that did show cancer. In most cases the measurable disease requirement will not be an issue but my wife’s case was unique.
Keep in mind also that trials generally have two or three “arms”. One group gets a placebo, one group gets standard of care (whatever FDA approved treatments are generally given to someone in your situation - whether or not it’s a good fit for your particular circumstances) and the other group gets the trial drug. Sometimes this is a “double blind” thing, neither you nor the provider actually knows what you’re receiving. If you’re on the placebo or standard of care arm and start to show progression, they will transfer you to the trial drug arm.
We went through the trial qualification process several months ago. It was daunting if your struggling with fatigue and weakness and rapid progression. She was ultimately qualified but unfortunately she was randomized to the the standard of care group and no one felt that would work for her. So we dropped out and fortunately the FDA had just approved Orserdu so she’s been on that for the past 3 months .
The trial sponsor handles your care after you enter a trial, not your oncologist (unless your practice is participating in the trial). This may require quite a bit of back and forth lengthy travel, but as others have mentioned the monitoring and care is typically at a higher level.
And one last important note, keep in mind there are different trial phases. Phase I trials involve new drugs that showed promise in animal trials but have never been used on humans before. We would not consider a Phase I trial unless the animal trials looked amazing and there were no other options. Phase II trials are for drugs that performed well in Phase I trials, and Phase III trials are for drugs that performed well in Phase II trials. So if there are equally promising drugs in various stages of trials, you would generally want to look for a drug in Phase III trials.
You can search for clinical trials at clinical trials.gov. Type in Metastatic Breast Cancer and enter your state and you’ll see what’s available in your area. Once you or your oncologist find a trial that’s you feel is worth considering, I would encourage you to find and read any available results or papers on the drug’s performance in earlier trials. Be your own advocate as to whether it would be a good fit for you, there’s a lot of info out there.
I hope this helps a bit and I wish you the best of luck in charting a path forward. It can definitely be overwhelming, just take it one step at a time.
Thank you! And yes, this is overwhelming!! I’ve not tried anything else besides my first line of treatment. Lots of questions to ask my doctor.
I’m fortunate to be at a cancer center that does this particular trial, so distance isn’t an issue.
You gave me lots of food for thought and I thank you from the bottom of my heart! ♥️
My experience with a trial was very different from what you are describing. I think CTGirl's will be more like my experience, because she is at Yale and I was at Columbia. My oncologist was running the local trial at Columbia. I got in immediately and did not need genomic testing (I got that done after that med failed) and all my treatment was from the same people in the same building. The difference was that I dealt with research nurses. They were great! So accessible. I had their cell numbers and could call them for anything, even getting a message to the oncologist. Also, I went to an oncology research clinic instead of the usual place for testing. That made no difference. Just a different floor. More testing than usual, and more rigidity. I had to see them on a particular date, monthly, no flexibility, so that messed up my vacation. All they did was count the pills and give me new pills.
The one thing you mention that will apply is the phase of the research. I am wary of Phase I, because they are testing for toxicity, so they will try to max out the dosage. I was in Phase Ib, however. I don't understand it, but they were not testing dosage. There were two treatment arms -- both got the medication they were testing. One was with Ibrance and one without. I automatically went to the arm with the treatment med only, since I had already failed on Ibrance. No random assignment, no placebo arm. I had a year on the medication before I was tossed out, regrettably, because I had barely detectable progression.
Getting in should be easy. Random assignment to conditions may determine whether she wants to proceed -- but it may be double blind....
Agree my experiences on my recent trial and upcoming trial have been very positive. Yes there is a time commitment and additional tests. However the additional testing gave me more insight into my overall health. Fortunately I live near the cancer treatment center, but I am also willing to travel. The trial team and my oncologist pulled me from the recent trial immediately upon progression. I was receiving the standard of care combined with the investigational drug or placebo. Ironically because I was in the trial, the progression was caught earlier than if it would have been under standard care. I take calculated risks and would consider a Phase 1 trial if offered. My care team would never knowingly put me in harm's way; I don't think anyone treating cancer would.
Hello CT Girl,I was on Ibrance/Letrozole for 6½ years, followed by Faslodex/ Xgeva for 1 year and now starting on Xeloda. Too soon to tell if Xeloda is working, my next step may be a clinical trial also. Genetic mutation negative for me too.
Wishing you the very best and please keep us updated.
Namaste 💮
Oh, this is a Phase III. All arms will get the med they are testing except for one. Those without PIC3 mutation, like you. That is a reasonable next step for you, anyway. Phase III they already know the tolerable dose. Go for it. My onc is always looking for trials for me. I got an extra year NEAD with a trial.
That’s wonderful!!! Congratulations and this gives me hope. 🙏🏻
Thank you and I wish you continued success on your treatments. 💗
Sorry, left out the one arm that does not get the med they are testing. That arm will get fulvestrant alone. I meant that is a reasonable option for you in any case.
I hope your scans show stability rather than progression! One thing to keep in mind is that we each have our own unique cancer cells, and our own response to treatment! I'm a long timer with MBC (19+ years since diagnosis, with mets from the get go) and one of my biggeest ways of coping has been to learn all I can: reading, conferences, second opinion from a bc onc at a major cancer center, support group for MBC in the city where I go for treatment & onc appts. Letrozole was my first treatment, with Zometa for the bone mets. I got almost five years from the Letrozole, and then over 9 years from Faslodex (aka fulvestrant). an injected drug given once a month if I remember right. I was also on Ibrance for a short time in 2016 when it was new, but it did permenant damage to my lungs. I've met quite a few women who've gotten longer from Faslodex than from an initial AI like Letrozole. Kinda interesting! I've ruled out phase I trials...maybe I'll change my mind in the future if I've run out of other options.... I got around 4 years from Exemestane, another AI. Zometa was switched to Xgeva when it became FDA approved as I was allergic to Zometa and had to have a lengthy protocol for getting it. I'm on so many other meds, too, for allergies, heart, lungs, skin, arthritis, hypo-thyroid, urinary issues, plus Effexor for hot flashes, Rx ointments for dry itchy skin, Rx mouthwash for ONJ (mild, caught early just a few months ago), and I've probably forgotten a few, lol. I see so many doctors, cardiologist, pulmonologist, primary care, allergist, dermatologist, dental surgeon, urologist, neurologist, surgeons, opthomologist, orthopedist, podiatrist. I got to drop one, the gynocologist I've seen for years as she retired and having my primary care doc take care of that for me was suggested by her. LOL, the things I'm grateful for! I'm on my first real chemo, Xeloda, as my cancer cells changed from E + to triple negative a few months ago. I have the hand-foot syndrome alot get on it, but I also have neuropathy in my hands, arms, feet and legs from spinal stenosis. My balance is wonky, and I have little feeling in my hands and feet. One of the things I think is really critical for our quality of life (QOL) is finding ways to keep csncer in perspective and not get obsessed with fear/anxiety/anger/other negative feelings. Enjoying whatever we can, keeping our sense of humor, staying close to family and friends. I miss gardening alot, and going for walks in the woods. I know I'm really lucky to have supportive family, friends, doctors, pets I enjoy, great medical insurance and a more than adequate income. And to still be here! Doing well for a year is a great start for you and may very well bode well for your future! Hang in there and keep us posted!
Thank you so much! You’ve been through the wringer, but I, like you, have a GREAT ATTITUDE and I live my life like I’m “normal”. I enjoy my margarita on Friday nights and try never to get anxious.
I just have too much living to do!! 🥳🥳🥳
So happy to hear you are a longtime survivor!!!
I get all the doctors, as well!! My first go round 13 years ago…so many issues because of the chemo and radiation, but I made it through!! I’ll do it again!! I’m very hopeful!! ♥️
you guys are amazing and a great inspiration!
I’m sure you’re JUST AS AMAZING!!! 💗💗💗
so nice of you!
Dana Farber has a great presentation on Trials by two Oncologists who give an excellent overview. Phase 1 trails can be first in human trials or combinations of existing drugs being paired together for the first time. My 1st trial was a Phase 3, my next trial is Phase 2. Safety is always the top priority. I liked what the Oncologists said "The best treatment is the one that is working", "Trials are no longer thought of as the last resort". "Some of the most exciting new compounds are found in the Phase 1 and Phase 2 trails".
The presentation below is a great overview of all the considerations for anyone interested:
They are a great alternative and I trust my doctor completely. She is candid and thorough!!
I’m really considering this and it’s in Phase III now.
Thank you for the link!! ♥️
When l failed that same treatment l was started on monthly faslodex injections and continued xgeva. No progression past 11 months. (I did have a tiny brain tumor but it's not a reason to discontinue faslodex because faslodex like most other treatments don't reach the brain). I do think going to faslodex should be a reasonable next step for you. I personally wouldn't think of going to a clinical trial unless there was a compelling argument to do so. I wish and pray the best for you. Let us know how you are doing and what your next treatment will be. ❤️🌺❤️
Just for some additional perspective, 5% or less of all oncology drugs that enter Phase I clinical trials ultimately receive FDA approval. Roughly 1/2 fail to show adequate efficacy and the rest generally do not progress due to toxicity or lack of funding.
The trial that my wife was qualified for but decided not to enter since she was randomized to the control group was subsequently terminated by the trial sponsor due to lack of funding.
The above statistic is a moving target of course as the oncology field is always changing (improving), just like the 5-year MBC survival rates. So it’s a rear view mirror viewpoint that may not accurately reflect current day trends, but it does offer some perspective.
Despite these less than exciting statistics my wife would not hesitate to try to qualify for clinical trials in the future, but there are obviously a host of considerations involved in those difficult decisions.
There are so many options!! Sometimes my head spins just reading up on everything. I read so much and am optimistic that I will survive a long time!! The world isn’t ready for me to leave yet!! 🙏🏻💗🙏🏻
Thank you so much for your reply!
Hi fellow Aussie 
I dont have time to read other replies right now but I would start with a search of "what to know about going on a trial" with a reputable organization. There are many factors to understand before deciding if a specific trial sems apporportae for you at the point of your journey, and a good way to develop a list of questions to ask them before proceeding. I was on a trial recently for my 3rd line since mets dx. It was good in that the team were wonderful and looked after me well, but in my case involved too much travel in the end (2 hrs each way) and costs not-covered by either my insurance or the trial, which was NOT expected!
I di find this fabulous write up about your trial, including a bit of historical references about it too. It could be a good one! - and Stage 3 means they've passed the dosing part of it, which is a good thing too. IMO one thing to lessen the risk with this trial is you would be getting Faslodex instead of letrozole (which migth've been what failed), many or may not get ibrance which you already know you can tolerate, and the new drug which does sound quite promising. Biggest question perhaps is, would this trial cancel out opportunities for other trials ahead if you go on it. Keep us posted about what you decide!
onclive.com/view/fda-grants...
Hi 13plus! Thank you so much!! First, I’m not an Aussie, but my dog is!! 😁 I live in the USA. I would love to visit Australia some day!! My niece lived there for a while and decided to come back (reluctantly) when those bad fires were happening. She absolutely loved it!! ♥️
I was given a huge packet to read about this trial and am compiling a bunch of questions.
The question you posed was not on my list, but it is now!! Thank you and I wish you continued good health!! ♥️
😂 now that’s funny! So when I looked up the trial it took me to a Melbourne, Australia location so I that’s why I figured you must’ve been in Australia. So it’s obviously an International trial! It sounds quite promising - glad I could help a teeny bit And thanks for bringing this drug to our attention to watch!
I thought you were adorable!! I have an Australian Shepherd (although they’re not Aussies), but close enough!!!
I’m feeling so much better after reading all the responses!!
I’ll keep everyone posted!! 🙏🏻
I am a 22 yr survivor. I took Aromason and Zometa IV for 7 yrs. I couldn't tolerate Ibrance's fatigue. Now I am on Kisqali and Faslodex. Still struggling with fatigue around the end of week 3. May your scans show improvement.
Thank You!! ♥️
hi! for what it's worth my FIRST line of treatment is a trial -
Awesome!! I wish you a lifetime of success!! 🙏🏻♥️🙏🏻
Hi everyone!!!
As promised…I’m back and my news is AWESOME. My scans showed STABLE!! No new growth and no new cancer anywhere!!!
So this means NO CLINICAL TRIAL for now. I feel so much better knowing I don’t have to stop my current meds and start something new. The trial will be there for a while if I need it someday!!
Thank you all for helping me with my anxiety. I appreciate you all!!!
Jody
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