Here we are again. A crossroads.
The third of many we will have.
I’ll give a bit of a recap. I know it gets quite technical but documenting the details is important for those who also have metastatic breast cancer.
It’s almost one year to the day that I was diagnosed with metastatic breast cancer in my bones and lymph nodes. I started on the cytotoxic daily drug Xeloda first (in addition to monthly infusions of Zometa) which gave me six months of success, shrinking the amount of cancer evident on PET scans.
In April 2013 when my tumor markers started rising I started on the hormonal combo of Aromasin and Afinitor (and also switched from Zometa to Xgeva because of difficult side effects I was having). I started on a 5 mg/day dose of Afinitor with a 25 mg dose of the Aromasin. I gradually increased the Afinitor dose to 7.5 mg/day, and then when my markers began to rise again a few weeks ago, I started on 10 mg a day.
It has now been five months on this combo (in all of its different dose strengths) and my markers are rising. This chemo is no longer working. So, it’s time to decide what to do next.
Regular readers will know that this is typical of metastatic breast cancer: some therapies may not work at all while some will work for a while. Ultimately, though, the cancer becomes resistant to each of these treatments and will progress. Sometimes you get a great response and can reduce the amount of cancer that is present. Oftentimes you settle for the success of “stability” where the cancer isn’t reduced, but it also isn’t growing. It’s often referred to as hanging out with “Stable Mable.” This is still a good response in most people’s books.
Especially when your cancer is still confined to your bones and lymph nodes, stability has the added feature of being life-saving: as long as the cancer is in those places it cannot kill you. Only once it metastasizes to organs can breast cancer kill.
So… now it’s time to decide what to try next (this part gets technical). Right now it’s looking like I’m headed to a clinical trial of a drug that has shown promise in breaking the resistance of hormone sensitive breast cancers especially in people like me whose cancer displays a Pi3k mutation (40% of people with ER+ breast cancer have one of these mutations). This experimental drug would be in combination with a drug commonly used for my kind of cancer (Faslodex). I’ve enrolled with the clinical trial team. This is a Phase II trial so I would be guaranteed to get the experimental drug.
What does this mean? In simple English, it means I’m trying a new drug that’s designed to break the resistance of this particular kind of cancer to treatment. It seems to be especially effective for those with the type of cancer mutation that I have (Pi3k-alpha). If this drug makes the cancer susceptible to therapy, then the other drug I’m taking can do its work. This class of drugs is at the forefront of where cancer research trials are right now.
I’ve been pre-screeened and have a few more hurdles to clear: scans, bloodwork, and a three week “washout” period where I must be chemo-free to allow any residual effects of my current treatment to clear. Am I nervous about a period with no safety net? Yes, a bit. But I also am curious how my body will react to having current chemo clear my system. I’ve had a lot of trouble with things like high blood pressure, high cholesterol, rapid heart rate, shortness of breath, and headaches in the past few months. I’m interested to see how many of these will improve.
The new drugs will have their own series of side effects, some of them might be similar and a few may be different and more serious. So this three week period sits okay with me because if my current treatment isn’t doing anything anymore, it’s of no use anyway.
There will be so much to share about being involved in a clinical trial. And I will share that with you, should I make it through the final screening process. I am learning so much as I go and I think there is a real chance here to inform others about the experience. Trials are as varied as can be. Each has criteria that must be met. Sometimes you end up on the good side of these and sometimes you don’t.
My oncologist looked at a host of trials before we chose this one. I was ineligible for many of them because of the drugs I have already tried, my particular features of my cancer, what cities the trials were offered in, when they were enrolling patients, etc. Some were not attractive to me because of the phase of trial that it was (I’ll explain in a separate post the differences between Phase 1, 2 and 3 trials). I am glad to be in a trial where a drug has already passed initial safety standards and will also be given to every patient in the group (there are no placebos in this phase of trial).
It’s important to note that a clinical trial should not necessarily be viewed as a “Hail Mary” meaning it’s the last remaining hope. In reality, my sense is that this is very rarely the case, at least with Phase 2 or 3 trials. They can only establish true efficacy in people who are still at certain phases of the disease process and haven’t had too many chemotherapy agents already.
To me the key was to find a trial that had a good scientific basis for success, was currently enrolling patients and was within commuting distance. In addition, I think it’s best if the standard of care drug is one you would already be considering using at this point in your treatment. There is a database at www.clinicaltrials.gov where you can search for trials.
I have reserved my spot in this trial. If I meet the testing criteria I will be one of 60 patients nationwide on this particular protocol, about 10 at my particular location. I view it as an opportunity. It is well-suited for my cancer at this time in treatment. It’s using the newest thinking in targeted therapy based on genomic analysis.
It’s scary, yes. But if it doesn’t work I still have standby treatments to go to (and other trials by that time that I hopefully would be eligible for). I know there is no cure. But maybe this one will give me a chunk of time.
I won’t go into details here but I know people will ask what’s involved. The treatments will be injections (Faslodex is two big intramuscular injections in the butt every month after doses every 2 weeks the first month) combined with daily oral capsule (the experimental drug). I will also continue to get an Xgeva injection in the arm each month. There will be a strict schedule of fasting bloodwork in NYC every two weeks and scans every 8 weeks to monitor the cancer’s growth. I’ll have to keep a medication diary. I’ll let you know how everything else works once I am underway. It’s a lot of work, especially in the first two months including all of the meetings and tests just to get started.
There are so many questions I know people will have. If you post your questions in the comments I will do my best to answer them in future posts if I can. You may post them anonymously if you like. For now I’m not going to state the name of the drug (actually just a string of letters and numbers) until I’m actually enrolled.
It was quite devastating to get the news that the current chemo isn’t working anymore. It always feels like the rug being pulled out from under me. I always cry. I always feel like I’m falling.
But plans are my safety net. Options are my lifejackets.
I leap from treatment to treatment on my tippy toes, knowing if I place too much weight I will sink.
This is the dance I do now. Forever.
Link to Twitter
I am relieved that there is a Phase II clinical trial that is well suited to where your cancer is at the moment. Having participated in a clinical trial myself (for a fertility medication), I know that qualifying can be rigorous as can monitoring, but the medication I took went on to be FDA approved and has helped other infertile women undergoing IVF. So, it helped me and helped others which I saw as a win-win.
Buying time is what this is about and I will be looking forward to your updates.
Fight on, Lisa, fight on.
So glad to know what’s going on and what’s next. So sorry (as always) you have this dance to do. xo
Hoping and hoping.
We haven’t met but words can’t express my gratitude for your work.
Wishing you every positive this next treatment could possibly bring you.
p.s. That sweet pup of yours is adorable.
As always, thanks for offering such a clear-eyed glimpse into the factors you’re experiencing and considering. And as always, I’m sending all the good energy I’ve got in whatever form works for you, Lisa #1.
Lisa, we look at the world similarly and I so appreciate the clear view I have of the world of metastatic breast cancer through your wonderful writing. It is as complex as it is tragic. Thank you for your honesty and I am rooting for you and hoping that you will be educating us for years to come!
I am glad that you found a trial that is (hopefully) a good match for you. I hope the break from the current chemo gives you some break from the headaches you’ve been getting and you’re able to manage the new side effects well once you start.
Lisa-
thanks for sharing the information on clinical trial protocols. Your blog is so incredibly educational and for that i am grateful.
Warm fuzzies to you
This trial sounds very promising, Lisa.
Wishing you every possible positive effect from this new course of chemo.
xoxo
Thanks for your thorough explanations. You really allow us a look inside your head :-).
The trial sounds like a good option at this stage of your treatment. It is starting in the Netherlands soon, but I am not eligible (having been on Faslodex before). Besides, my tumour doesn’t have this specific pi3k mutation (though I am ER+, like you are).
Faslodex was the best hormonal therapy I’ve had: no side effects and no daily tablets (just this monthly injection).
I hope it buys you time!
What an amazing amount of research to find a trial that’s a good match for you.
“I view it as an opportunity”, says so much about you, your indomitable spirit, and the support you’ve gathered all around you to keep moving forward on tippy toes. From the bottom of my heart, I wish you the very best at this time and always.
Lisa, I love this informative post, especially all the considerations that go into whether to enter a clinical trial. I have been on my trial at Stanford for ten months. So far, my cancer has been stable, so I cling to that. The trial has at least extended my life such that I could witness my son’s wedding last Saturday. He’s the first son to marry, so it was very exciting and emotional. We just keep on truckin’, don’t we? Here’s hoping that you make it into this trial and it does wonders for you. Life is precious. Thanks for your writing. You encourage us all. xox
Brave bold helpful amazing Lisa….thank you for continuing to share your journey with us.
Thank you so much for the education you have provided to me and to others and G-d bless you as your continue on your path to wellness.
Thanks for sharing the information on the trial. Wishing you much success with this trial.
Hoping the best for you, for you to qualify for the trial and begin, that you find success on the trial, and that you can “enjoy” the 3 week reprieve such as it is.
I came across your blog while researching for a Pinktober post. ( I want to be very, very careful to have all my facts straight) I hope this trial works for you, and when it stops that the next one will as well. You’ve done a huge service to the BC community by sharing your story!!
I feel the same way, Lisa. I am thinking of you as I am also leaping treatment to treatment. How is Xgeva working for you? I just started this injection due to mets to the right hip
Thank you for taking the time to give us all of this information. It’s overwhelming what you must go through at this stage of the game. This is all incredibly useful information for those of us considering clinical trials. I know there are some clinical trials for triple negative breast cancer that I probably ought to look at. While I have the luxury of time to consider them, you do not, and it must be sort of scary to be thrust into that world all of a sudden. You are brilliant and so well-informed and I admire your ability to tackle this. I will be waiting for the sample Lisa Adams Clinical Trial Notebook!
I so hope you get in this trial.
love you,
Amy
I hope the trial works out and gives you a very long dance before you have to switch partners again.
Sending you love and courage. Neither one of us ever thought we’d be reading about trials with baited breath. I’m with you every step of the way.
xxoo
jody
Lisa, thanks for such a well-thought-out explanation of what your trial will involve. Even though my cancer is radically different than yours, it is still good to learn about these things. Keeping you in my thoughts all the time.
Here is an account of my experience with a clinical trial:
http://everydaymatters.typepad.com/every_day_matters/2012/03/trials-and-tribulations.html
thanks for this post. these fact-based updates are exactly what my brain likes to crunch on…also probably they make me less weepy! hanging on every word, know that you are in my thoughts so often. miss you. xo
Thanks for sharing all this information. I’m not entirely familiar with the vocabulary, but what I understand sounds well planned. Thinking of you and your delicate dance always.
I too am in a clinical trial, which is attempting to demonstrate that everolimus (affinitor)– as you know well, already approved for your cancer– is useful to delay progression in my kind of cancer, so it can get approved for other patients like me to use. It’s a Phase III trial. There’s a 1/3 change I am on the placebo. It’s this one http://clinicaltrials.gov/ct2/show/NCT01524783 (Don’t read that too closely, there’s discouraging numbers built in to the drug company’s expectations.)
I am so looking forward to what you write about the experience of being a science project. Most of my friends don’t really get what ‘clinical trial’ means, but like me you are committed to approaching disease with the mind of peer-reviewed science. @mir_b
Thank you for the update. I wish you and your body only the very best as you enter this clinical trial. Much love to you and your family.
Your ability to retain clarity, to explain in a way that is easy to grasp, and to share information is to be admired. I get so emotional reading your posts, but it is a good emotional: full of admiration, gratefulness for your generosity in sharing, and hope. I have come to care so much for you and your family. This is good, important work you are doing. And you are in my prayers (not that I am some holy-roller church-going religious person – just a person who would like to believe in a loving God/Goddess/Source/Creator/Essence and who figures praying can’t hurt and it might help). Keep up the good work, but always remember to take care of yourself, be gentle with yourself, rest, and enjoy. Peace!
Your ability to maintain clarity, to explain information in a way that others can understand and learn, and your generosity in sharing your story amazes me. I always get emotional when reading your posts – but it is good, it is a feeling of appreciation for your openness, and a sense of connection. You are doing important and much appreciated work. I have come to care for you and your family. You are in my prayers (not that I am a religious holy-roller, just a person who wants to believe in a God/Goddess/Source/Essence of love, and thinks that praying can’t hurt and might help). Know that your writing helps others. Take good care of yourself. Peace, baby!
Thank you for the update, Lisa. Holding you in my thoughts and heart as you tackle this next chapter. I know you wish you didn’t have to do this dance. We all wish that for you and for all those doing the same.
xoxo
Hi Lisa,
I appreciate the opportunity to read your blog. I’m wondering if you ever connected with an oncology nurse who worked for the Afinitor drug company…
I was diagnosed with stage IV renal cell cancer with bone metastasis in April, surgery in May. I’m also on Xgeva and was on Sutent for
cont’d
I was on Sutent for 4 months. During that time, I received calls from that drug company’s oncology nurse as part of their phone support program…very helpful. When 2 new tumors showed up in my liver, I was switched to Afinitor 10 mg and am now ending my 2nd week on it. I was told that Afinitor has a similar nurse support program, but I’ve been unable to find information about it online. If you have any contact info for this program, i’d appreciate hearing from you.
I’m sending you all the best as you embark on this new phase in your journey.
Warm wishes… Nancy
Nancy, maybe these will help. If you google “Afinitor nurse support” there seems to be info including this from the company:
http://www.afinitor.com/advanced-breast-cancer/hcp/nurse-support-hotline.jsp
http://www.afinitor.com/advanced-breast-cancer/patient/nurse-hotline.jsp
Good luck, hope this helps!
Thanks, Lisa!
Sending you hugs and healing energy.
Hi Lisa! I’m Dana, I also am stage 4 breast cancer with mets to bone, lymph nodes and newly diagnosed new mets to the lungs. I just started aromasin & afinator. I am about a week in to those drugs. I had a good run of almost a year and a half just on femara and Xgeva shots! That was a blessing. Now the pet showed movement to the lung & I’ve started the new treatment. Dr also talked to me about Faslodex and clinical trial options. Not in detail yet. I was hoping you could shed some light on how long it took to enroll and how long it took your dr to find the “right” one to try? I’m scared. I can relate to your feelings as well. The rug feels like it gets pulled out from under me too. I feel time isn’t on my side and not sure this medication is for me. Side effects are plenty and the reward doesn’t seem good enough. Afinator is just supposed to try and slow things, not Even sure it will. How long did it work for you? Did you get mouth sores? Vomiting? Fatigue? I’m on 5mg and I feel all three symptoms after only a week.
Good luck to you! I’m happy I found you online! Sounds like we have similar paths. My dr is also in NY. Sloan Kettering.
Look forward to hearing from you,
Best!
Dana
It varies so much. The main thing is whether the trial is enrolling at the time you need. You need to meet the exact requirements, usually have a lot of testing done including scans, and then usually. 2-4 week washout period where you can’t be on any chemo.
I didn’t have any of those on Afinitor except brief mouth sores. It did not work for meg or long, about four months, but no way to know until you try. But sounds like toxicity will prevent you from getting a higher dose. I went up to 10 eventually.
Here are many different genomic subtypes and mutations so you can’t look at anyone else’s outcomes as predictive of your own…
I wish you the best and hope these will work for you. Finding the right trial is time consuming and you have to really balance if it’s worth the risk and if it offers you what you want. If so it can be a great opportunity. But always look at it carefully.
Thank you so much for the info Lisa! Since I last wrote you things have changed…I act silly did get bumped up to the 10mg evrolimus but then the heart and lung function became labored because of the toxicity of Evrolimus and also becaus Pet/ct scan after 5 months on the combo showed no improvement and actually more disease. I have a small spot on the liver now and have more bone lesions. So that treatment didn’t work to say the least. The GOOD news here is, I did get enrolled into a clinical trial named ARN-810 through my dr at Sloan! You were right…long process getting enrolled with all the rerequiste scans and testing and bloodwork ups. Hopefully this trial will work and slow everything down! I’m hopeful! Drs are too! They have had good results so far on the stats. So far I feel better. Started off very sick but side effects are under control now.
Thinking of you on your path….
Prayers are with you & thank you again for your input…sorey it took so long to respond…but now I got to tell you the good news of the clinical trial!
Xoxoxo
Best,
Dana
Hi! Sorry that the drug didn’t work for you. Would you do me a favor and let me know how you do on ARN-810? That’s one I’m watching closely as I have ESR1+. Is it a single agent trial (just the ARN) or is it with something? Want to keep track of how you do on it! Lucky you to get it. How ling until first scan? 8 weeks or 12? Good luck!! Is Dr Dickler the Principal Investigator on that one?
Lisa! Hiii! Happy to get your response!!!
Yes, Dr. Dickler is the head Dr. On the trial…my main oncologist is Dr. Victoria Blinder, she recommended the trial for me thankfully!!! I literally hit the trial lottery opening because it was about to open around the same time as I was off the evrolimus to let my heart and lungs settle…I’m still in the first 2 weeks of ARN..I have my first 4 week scan coming up that will be an FES PT Scan and then in 4 more weeks my CT to monitor tumors…I had some stomach side effect issues in the beginning but were quickly resolved with meds..I’m doing and feeling great so far! Keep you posted!
Dr said I has the most amount of estradiol in my system out of anyone so far enrolled so they will be excited to see if the ARN works well on me!
Crosses fingers
Xo
Lisa!
It’s me Dana again…
How are you doing on your clinical trial? How are you handling the Faslodex?
I also have been on Xgeva shots every 4 weeks for the past 2+ years..
I posted about myself and the trial I am on and didn’t ask you about how you are doing? I really am curious..you posted this back in sept of 2013…almost a year ago…unless I am missing your updates, I haven’t seen one on how you are doing since the trial started…
How are you?
Xo
Thinking of you…
I really appreciate all the detailed information too. My mom has stage four breast cancer very similar to Dana’s. In fact sounds the same. My mom is 72 and was diagnosed with cancer the first time four years ago. She has been doing natural treatments along with the conventional. She’s been on herceptin and a bone strengthening drug since November 2013 every three weeks. She is also getting intravenous vitamin c every two weeks and getting mistle toe
(iscador) injections in her stomach three times a week. Her diet is very restricted but she’s really wanted to do it. I have to say that my mom hasn’ t thrown up, gotten any mouth sores or the fatigue that comes with chemo. I think it’s all the supplements and vitamin c and mistletoe that’s really helped. She has lost a lot of weight, but i think mostly because of her diet because even the day of chemo she eats great. The radiation has been the only treatment where I notice that her appetite is much less. I can send a detailed list of all the stuff she’s doing if anyone wants. Anyway, the herceptin has stopped working and now they are going to start her on xeloda and tykerb pills. I think this is the hardest thing I’ve ever had to go through with many layers of feelings and thoughts. The hardest part for me is just realizing that my moms life is coming to an end. I’m just trying to roll with the punches and enjoy each day, months or years that we have. Sending all of you lots of positive energy. Thanks, Juanita
I had breast cancer in 1996 and had surgery, chemotherapy and was put on Arimedex. My cancer is estrogen positive. Five years later it showed up again and I had surgery and radiation. In 2010 they told me I was cancer free and took me off Arimedex. In 2013 the cancer returned and I had more surgery and radiation plus I was put back on estrogen blocker. In 2014 a CAT Scan showed it in my bones. Now they have added Afinitor to block the mTOR. I have been on it for 2 weeks and have the mouth sores, loss of appetite and fatigue. Today I had my first blood test and find out the results tomorrow. I have tried to learn as much as I can about the drug and side effects. Does anyone know how long the drug works and do I need to be on it the rest of my life or does it kill the cancer in the bones? Thanks!
Lisa- First of all I want to thank you for sharing this information. Our stories almost parallel. In April it will be a year since I was diagnosed with stage IV breast mets. In bone, lymph nodes and in my case, the liver. This is my third rodeo with breast cancer. First diagnosed in 2003. Had a nice 8 year break with NED. Then in 2011, it was detected in other breast. Bilateral mastectomy especially and reconstructive surgery followed. Also found out at that time I have the BRCA 1 gene. I had 4 months of taxol followed by Aromasin. Aromadin now not working. (PET scan and tumor marker numbers show progression ). Dr. now wants to start me on Afinitor. We are survivor sisters. I will be praying for and thinking of you as you go into this trial. Keep the fairh. There is always something new around the corner to try. Thanks again for sharing. Kathy K.
I was told I would be on chemo and radiation, but I am on tamafloxin now. with a monthly xgeva shot. so far, I havnt had noticeable reactions to medications, and they seem to be working. the big surprise of the treatment was the 2500.00 co pay, with the insurance paying 1090.00. I asked about the possibility of a generic for the xgeva, and they cut down he cost to 250.00 per month. Maybe guys have different side effects and reactions to tamifloxin than gals. I also have a 90 day spaced flush of the “power port” that was installed for chemo when I had my mastectomy.