There is so much to say about the start of the phase 2 clinical trial earlier this week. I think it’s important to be as complete as I can on the main parts. I really want readers to get a sense of what it’s like to go through this and also what to expect if they decide to enter a trial themselves.
That said, it is obvious to me (and hopefully to you) that my experience is very unique. I have no earthly clue what other trials are like. I just want to make all of the disclaimers that I think you all know already: this is my experience only. If that helps in some way, great. But it can’t possibly tell you what another clinical trial might be like.
I still think it’s valuable. And I know I would have wanted to read posts like these a few weeks ago when I was signing up for the trial. So that’s my guide: if I think it would have helped me, I’m going to share it.
Twitter friends have been telling me that they are interested in five main topics: 1) what is the science behind this drug? 2) what does the treatment consist of/logistics 3) how did I choose this trial out of the ones available 4) side effects physically 5) effects emotionally. The last two will obviously be the ones we follow over time. I won’t be able to address all of those topics here but I’m getting a good jump on them.
This post is long. I’ve opted to just publish it and not divide it up. If you want to read it in chunks you can decide how to divide it up. If you want to skim the science parts, you’ll still have my report of my day at the end. I look forward to hearing your questions and comments. If you have questions I will try to answer them.
First, a bit about the drugs and the science behind them. My trial has me taking 6 mg of an investigational drug called GDC-0032 made by Genentech every morning. I receive two injections of a drug called Faslodex every month, with an extra dose halfway through the first month.
It is important to understand that these particular drugs for metastatic breast cancer are not traditional (cytotoxic) chemotherapy drugs. What I mean by that is that most people think about chemo as being drugs you receive, most often via IV, that makes you feel rotten and your hair fall out. That’s the type most people are familiar with and that class of drugs includes what I had when I had treatment for stage II breast cancer in 2007 (Adriamycin, Cytoxan (least creatively-named drug of all), and Taxol).
Those drugs are cytotoxic (cyto= cells, toxic= poisonous). So, the drugs kill the cancer cells but they kill other cells too. That’s why your hair falls out, you feel sick, your blood counts drop and a host of other issues.
With my kind of cancer (estrogen receptor positive, progesterone receptor positive, HER2 negative) there are other types of drugs to use to try to slow the cancer’s growth down. This is not the case for all types of breast cancer. With some you can only use traditional chemotherapy. In addition, and most importantly for this trial, my cancer shows a mutation in the Pi3k pathway. I know this is getting very science-y. But I’ll try to explain the rationale for this drug.
Many people with my kind of breast cancer (and other types of cancers, we’re learning) show a mutation in this pathway. You might have heard of genomic sequencing. It is testing the tissue of your cancer to see if your particular cancer has any mutations in its coding that facilitate the cancer’s growth (I’m oversimplifying here). This pathway, which is called the Pi3K/AKT/mTOR pathway, can become overactive and drive the cancer’s growth.
I have one mutation in the Pi3k section of the pathway. There are many forms of mutations in the Pi3k pathway. There can be other mutations in other areas as well. Mine is called a Pi3k-alpha mutation.
So what the investigational drug is targeted to do (hence the term “targeted therapy”) is to block this Pi3k/AKT/mTOR pathway that has been over-activated, potentially by this mutation.
This all sounds great. But it’s not so easy. It isn’t as easy as “find the mutation, create the drug, block the pathway, cancer goes away.” We don’t have indications it will ever be like that. The signaling pathways of cancer are highly complex, variable at any given point, and also change over time.
In addition, not everyone with the same mutation responds to the same drug. And combinations of drug seem to work better. Think about doing clinical trials of endless permutations of drug combinations with different mutations, different cancers, in different bodies… well, this is why science seems to move at lightning speed but our advances in treatment just don’t mirror that in all cancers. We have no way at the moment to predict what the best course of treatment is for any individual person. For now, you throw the pasta at the wall and see if it sticks. Unfortunately, our lives are the test cases.
To return to the science, I’ve already tried an mTOR inhibitor in my last treatment phase. That was called Afinitor (combined with another drug called Aromasin). But that targeted a different end of the pathway, and not the mutation. The problem with all of these right now is that the cancer figures out a way around the blockages. It develops feedback loops. If you’ll allow me to anthropomorphize cancer for a minute, it says, “Hey, okay, so you want to block the road? I’ll just detour and still get the end point. I’ll get fuel to the cancer somehow. If you block me, I’ll just keep finding a new way to deliver the goods.” And that’s why metastatic breast cancer is incurable. It keeps finding a way to find fuel and becomes resistant to each thing you throw at it. I became resistant to that Aromasin/Afinitor combination after about six months.
In terms of side effects, unlike traditional IV chemo, with this investigational drug you don’t “feel rotten” right after treatment. It can take weeks and potentially months for side effects (especially some of the serious ones) to take hold. So that’s one way this differs from what people might think. My phone has been buzzing non-stop since Monday: “How do you feel? How do you feel?” I will have some effects from the injections (which are hormonal agents, this one is an estrogen receptor agonist) quickly. I already have some of those. Other side effects from the pills (the GDC-0032) will come later.
So… here we go.
Monday was Cycle 1, Day 1.
If you are interested, my trial protocol is here (I am in the phase II group). This tells you exactly what this study is. If you want to read a bit about the early results of this drug in phase 1 trials you can see that here.
On day 1 I received my GDC-0032 pills for the month (and took the first dose), received two injections of Fulvestrant (Faslodex), and had about 8 vials of blood drawn.
The logistics of getting to the city were a bit of a challenge this week given fatigue and the lingering pleural effusion. The train, subway, and walk were tough but I always try to push myself. Knowing I’d be stuck inside for a few hours definitely had me enjoying the cool crisp fall air on the walk to the hospital.
Because of train times I arrived one hour early for my appointment. I wasn’t sure if I was doing this blood draw before seeing the doctor or after so I settled in. After only a few minutes I was surprised to be called back to an exam room. There I had a long meeting with research nurse whom I’ve spoken with by phone but not met in person. It was an extremely thorough meeting. She answered questions, reviewed the protocol, went through my current medications again, noted all physical symptoms I’m having now. We also discussed my most recent bloodwork (my lipids changed drastically during the 3 week washout period. My prior chemo had raised my cholesterol significantly. My LDL dropped a whopping 100 points in a two week period once I stopped the old chemo, for example). Blood pressure, pulse, oxygen saturation, height, weight. Other research assistants on the protocol come in and talk to me, discuss things, physical exam, as eventually does the Principal Investigator (the doctor in charge of the trial).
It took about two hours to complete these meetings, exams, tests, questions, medication review, etc. Everyone was very thorough and I was offered every opportunity to ask questions about not only the trial but also about any symptoms I was having and how they could be helped.
They also stressed how important it is to call with any and all side effects. As the more serious side effects become more possible/likely, it’s important to report any issues right away so they can be managed before they get too serious. Communication is key in clinical trials. I’ll talk about the side effects more in the future.
For some questions about side effects we needed to refer to the protocol of the trial (Can I get radiation to a bone if my bone pain continues: Yes, but not within the first two weeks of the trial start. Can I get the fluid around my lung tapped if it becomes too troublesome: Yes, at any time).
We also discussed a port for my blood draws/access for radioactive dye injections for CT and bone scans that I will need to have done every 8-12 weeks on the trial. I am still undecided about the port. We agreed to see how it goes in the next few weeks with the blood draws. I can only use my right hand which doesn’t allow for easy access or many misses. They tell me there is a “three miss rule.” If they can’t get the blood they need within three tries, they stop. I have a terrible feeling this rule will come in handy.
At the end of the meetings they handed me many sheets of paper.
First, I received a medication diary where I need to document the time I stop eating every night and the time I take my GDC-0032 pills (the “investigational drug”) the next morning. The pills must be taken on an empty stomach one hour before food, with a full glass of water at approximately the same time every day.
Second was a list of drugs and supplements I cannot take while I am on this protocol.
Finally, there was a schedule for the next 8 weeks of what will happen at each appointment, what tests and drugs I will receive, what I need to do to prepare, and what I need to bring to each appointment. The pills are given in quantities of 30 but I will probably be at appointments every 28 days. The surplus pills must be traded in and counted before I can receive the next month’s supply. Though it is only one drug it is dispensed in two capsules, one dark red, one pine green. One is a 5 mg, one is a 1 mg for a total of 6 mg.
I was then sent to do scheduling for my next appointments. I will need to return in two weeks (plus or minus 2 days) to do vital signs, exam, fasting blood draw (but this time it must be done twice: before taking my pills and then again 4 hours after), and my two injections.1
I then went to the hospital pharmacy to collect my pills. They are labeled with my name, the drug name, instructions, and so on, just like a regular prescription. The protocol number is labeled on the bottles too. The bottles also say “Cost $0.00” on them.
This drug is provided free of charge to me but my insurance company is billed for the injections of Faslodex, lab work, and all scans. Trials differ in what is covered. In this case, only the investigational drug is provided free of charge. The rest of the expenses including the visits with the doctors are not provided for free. I am fortunate. My insurance will help pay for those things. Your care is not necessarily fully covered when you are in a trial, contrary to popular belief.
The pharmacy cashier placed the two bottles (one bottle of the 5 mg, one bottle of the 1 mg) in a brown paper lunch bag and handed it to me. In that moment I feel like I have something very valuable and secret in my possession, perhaps even magical. I don’t know if these pills will do anything for me. They could do me more harm than good. They could do nothing. But they might buy me time. Those are, for now, mysteries.
The brown paper bag with the drug bottles inside seems very wrong, far too flimsy for the weight of the hope that lies within.
I then left the pharmacy and headed upstairs to the chemo floor where I had my fasting bloodwork done (by now it was past 11 AM and I was glad I started early. I really don’t mind not eating, it’s the lack of coffee that gets me. Also, the longer I wait the harder the blood draw is likely to be).
In this room I will also receive my two injections. As I enter the room, I’m wondering about those and anxious. The number of needles I have in a month is astounding sometimes. I was the girl so afraid of shots as a kid I once ran into the parking lot to try to run away to avoid getting a vaccination at a pediatrician’s visit.
One chemo room is dedicated to this trial. I have gone to the same room each time so far. The trial tech doesn’t even try to draw my blood. He calls in the reinforcements. Eight or so vials of blood are taken by a nurse who goes after my hand vein with a vengeance. Unfortunately I receive a call the next day that two of the vials are unusable (hemolyzed). This happens sometimes when large blood draws require a lot of work (suction) to get. I was able to go locally the next day to have the two vials redrawn.
After the blood draw it was time for the “standard of care” drug. This is part two of my clinical trial protocol. The “standard of care drug” means I am given not just the experimental drug, but also a drug that is a reasonable option for treatment for this stage of my disease.
On its own (“single agent”) Faslodex works for some people but seems to have a better track record when combined with another agent. My trial is one that combines Faslodex injections (standard of care) with the GDC-0032 (the investigational drug). There is no placebo. This is a phase II trial. I will get both. We will see if taking the GDC-0032 provides a better result than the historical success rate of those who have received the Faslodex injections alone. There will be 60 people nationally doing this combo, about 10 of them at Sloan-Kettering. I am the fourth person, I believe, to get started on it (the trial just opened a few weeks ago at Sloan).
Faslodex is given by injection, intramuscularly, in your rear. No fancy fun way to say it. You drop your trousers and they have syringes that are over 4″ long (can’t find any literature that states exact measure. I’m going to ask to measure it after my shots next round. I confess I saw them when we were done and they made me a bit nauseated and I didn’t want to be precise!). The needles are thick because the liquid that has to be inserted is very viscous and doesn’t go into the muscle easily. I was fortunate and the nurse did a great job. I tried to remember the tip to keep your muscles relaxed during an intramuscular injection, but it’s hard when you know the size of the needle that’s taking aim for your ass.
The first injection really wasn’t worse than a regular shot. The second one hurt more than the first but still less than I had expected. I opened my bottles of pills, took out one of each, drank my water as directed. I noted the time in the diary.
At this point I was free to go. The injection sites were not immediately painful and I was sent on my way.
Everything was incredibly efficient and while I was exhausted, I was relieved. I kept thinking to myself: “Once again after three weeks of not being actively treating my cancer because of the mandatory ‘washout’ period, I am doing all I can. Action feels good.”
I celebrated getting through day 1 by having lunch with my friend Julie Klam which was such a luxury after the poking and prodding of the morning. I took the train home and felt a sense of accomplishment.
So, in case it wasn’t clear, my next appointment will be two weeks after my start date (“Cycle 1, day 15 +/- 3 days” in protocol speak.).
I think the word that most defines metastatic breast cancer to me is “uncertainty.” You have to figure out a way to live with it. My coping mechanisms are research and action. I can only hope these will serve me well.
I thank you for your support and encouragement this week.
- I also will be continuing to get a monthly injection in the arm of Xgeva, a drug which helps to strengthen my bones [↩]
Link to Twitter
Such an informative and interesting post. I appreciate that you are sharing everything about what a trial is about. Sending lots of love…and TLC for your sore tush:)
Thank you so much for putting all this information together with such clarity.
Wishing you the very best results from this combination of drugs.
xo
Thank you for sharing. I love to know what other women are doing for their metastatic breast cancer. Wishing you the best.
Gina
Excellent synopsis of the trial and your first visit. Only wish oncologists could be as clear in their explanations. Why such a limited enrollment in the trial? Sixty seems like a fairly small sampling.
Wow. Read it all. You are so educated on this. I’m sure you’d rather not be….supporting you every step of the way. Hugs.
Thank you for posting this, Lisa. It really paints the picture quite well. Best to you moving forward.
I read every word and am so happy to know the (or some of the) details, as I’ve been thinking about you so much since Monday morning. Knowledge is power. Lots of uncertainties still as you say, Lisa, but wow are you a perfect person for this trial– you’ll be helping others greatly because you are so precise in following your required protocol actions and in your reporting back to the PI team. And let’s hope fervently the trial helps you too.
Whew.. what a lot for you to digest, both mentally and physically. My own experience with CLL, admittedly a day at the beach compared to yours, is that being actively involved and intellectually engaged with your treatment and your doctor and if it makes sense at all, being professional about being the patient, has a lot to do with your own mental health, and you are the prime example of that.
I am continually astounded by your clear and concise explanations of your physical and emotional trials. Hooray for action and hope!! I wish heartily that this treatment lasts a long, long time and helps you feel better. Much love to you. xo
Thank you for being the constant educator. You’ve really done an amazing job of explaining things, Lisa.
Action is good! Yes. Go get ’em, Lisa.
hugs, hugs, hugs…
P
Thanks Lisa for using your precious energy to share your experiences.
so thankful that of all the things you could be doing, you spent your time putting this together for us. know that i appreciate every word of every post and every tweet. let the action begin!
xoxo.
Great article! I have been taking faslodex alone for about 3 years now! It is working good for me. Good luck to you in your trial. Stay positive!
I read this all with great attention. It is not lost on me that even though I don’t know you, I feel intertwined with your story, your life, and all you are doing to buy time and combat this dreaded disease.
I feel such a kinship to you, a sisterhood, which is not uncommon in the blogosphere. I lost the two most important female mentors of my life to cancers (one was 42 and one 56) and, as crazy as this might sound, your fight and your writings make me feel closer to them (I guess in a way that I better understand in broad terms what they were likely going through now better than I did all those years, decades ago).
I hope, hope, hope this trial in beneficial for you.
Thanks for this very informative post. I should have posted more about my clinical trial experience, so am grateful that you are going into so much detail. I do hope this trial really works for you. Uncertainly certainly sums up metastatic breast cancer. We just have to take each day at a time. Brava! xo
Such pragmatic, careful communication. Thank you.
So glad to hear all about this. I have great hope and much love to send you.
Very, very interesting; and I can see why it took a couple of days to get it all down for us. Thank you for doing so. And thank you for erring on the “extensive” side rather than the abridged version (although, I’m sure we all appreciate the…how did you put it?…”oversimplifying” in some spots). This is a world I’m so very sad I have a window into … I wish so badly this blog could go back to “only” being about Tristan and your dear MIL and reflections on the past hurt of cancer. I know that does no good, though…either for me or for you.
I think about you all the time. Chemo is making me weepy and fragile…I’m tired all the time and fall into sobs easily. You are not infrequently one of the causes. Strangely, though, it’s not because of some dreaded end I fear for you; it’s more because of the strength you must dig deep to find. I compare myself to you…my friends call me strong and a trooper and praise me for being so positive all the time, blah, blah, blah…they mean well, but I think, “They don’t know SHIT about strength!!” And neither do I for that matter!! No one can even fathom the depths to which you have dig every. single. day. The phrase, “I can only imagine” is silly in its inadequacy. I know you’d say that you’re just doing what you have to to survive, and that you have no choice; but I’m still in awe of you.
Do you ever get to be fragile? Do you know people who let you do that? Someone who you can crumble in front of? I hope so. I really hope so. That’s so important.
On a very practical note, I have on question: why the hesitation in getting a port? This post is hardly the first where you mention the difficulties in finding/accessing good veins…what’s the downside for you?
Lots and lots of love,
Laura
You amaze me. The clarity with which you outline the events is perfect. The fact that I am personally familiar with so many of those rooms brings me right beside you. Because my mom is on faslodex I completely understand how that goes.
I’m familiar with the pathway they are targeting (science geek) and I hope this is a breakthrough for you, Lisa.
Love,
AM
ps-IF IF IF your liver enzymes spike during the initial load period on the faslodex, please DO contact me…. there is an oncologist at MSK who can give them info. My mom had a problem but they returned to normal range.
Hope, perseverance, energy and love to you, Lisa.
N
Hope it turns out to be a great drug combo for you. And I hope you avoid the worst of the side effects. That said, get the port. It takes a few weeks to get used to but makes any blood draws or infusions so simple. Always in awe of your clear explanations and your clear emotions.
Lisa – this is a fantastic post, not only in the way you have detailed your experiences and demystified the clinical trial experience for many, but also how you have explained the complexity of cancer and why finding “the cure” is so difficult. Wishing you the best.
Lisa, Thanks as always for your skill in describing the details of a clinical trial. Couple that with your engaging way of telling what you are feeling physically and psychically through all this and you do us all such a service. Thanks for your strength and positivity.
Thank you for sharing your journey with such honesty.
I had a port for 6 months and while I didn’t like the door bell appearance, the chemo infusions (96 hours each time) and many blood draws went smoothly.
Wonderfully thorough. Love the science! Thank you.
Very interesting post. I am fascinated by the body and what it can do and I appreciated your taking the time to explain it all. Enlightening to say the least. I am a new follower so may I ask why you can only have blood drawn from your right hand? Maybe you’ve explained it before but I’m not sure where.
I wish you all the best in your new phase of treating your cancer! At the risk of saying one of those things you’re not supposed to say to a person with cancer, I have a friend who is stage IV metastic breast cancer and unlike you, she and her family don’t want to discuss it. I know each person’s experience is different but reading your posts helps me understand maybe just a little bit better what she may be going through. Thank you!
Hi… I’m glad it’s helpful to read the posts. I always say one of the reasons I do this is to help inform friends and families of those who may not be able to share or are not as comfortable with being open as I am. I think the more we explain what we are going through the more we are truly educating and accomplishing “awareness.”
As for the blood draws, I had a double mastectomy with lymph node removal on the left side in 2007. After those surgeries it is not generally recommended that you use the side you had nodes removed from for blood pressure or blood draws because they feel there is an increased risk of lymphedema.
That said, it seems they may be changing their thinking and only making this caution if the person had a large number of nodes taken (this was news to me but was discussed yesterday). They have been collecting data to see what the outcomes are. So it may be that I can use the left arm now that we are really needing it.
My right arm was used for IV chemo in 2007 so the big veins in the bend of my elbow are all shot as are many in the forearm. They’re still scarred and unusable.
You presented this information very clearly. Thanks for taking the time and effort to post. I am wishing the best for you.
Lisa, thank you for sharing this experience with us. It helps to read about the specific of a clinical trial–especially for those of us who are considering one! I feel your pain of getting shots in your butt! I get a shot every 28 days that is like hot molten sand with a really big needle! I’ve been told that it helps the pain if you lie down for the shots and since you’re getting two at a time, it might help you. I haven’t tried it yet as so far it hasn’t been too bad. The “after” pain is much worse for me on one side than the other for some reason.
I’m hoping that this trial works for you with little or no side-effects.
You have a gift for explaining complicated technical information. I read every word.
Thanks for this post, Lisa. I am a stage iv ovarian cancer patient and I always am moved and inspired by your posts. My advice to you is to get a port. I have a Power Port, and it makes draws, chemos, IVs soooo much easier. Good luck to you in these clinical trials!
You are the only person I know who could document a trial like with such clarity. You’re the only person I know going through a trial like this who could document with such clarity.
xo
Thank you. xo
Thank you for sharing all of this Lisa. Good luck with the trial, and I hope it has great results for you. I’ll be starting a trial in the new year… it is good to read about your experience, even though the drugs are different. ~Catherine
Thanks for such a clear explanation of the start of a trial. I never realized how much a person had to go through. Hoping only the best and that the trial works wonders for you. I have been on Faslodex since 2011 and X-geva since 2012. My side effects are very minor – wishing the same for you.
I’m totally in awe of your spirit. The fact that you are sharing your journey with us is so very kind & important. You are showing us there is always hope & teaching us to ask questions. I don’t know your reason for not already having a port, but will say it was one of my best decisions. Sitting thru the day long chemo sessions I saw many patients being poked & prodded while nurses searched for veins and I ached for them. While I realize they may not be for everyone, the port made my life much less painful for the infusions as well as the blood draws & left my veins in tact. Whatever you decide know that you have many, many friends out here praying & pulling for you to do well in this trial. May you be blessed.
Lisa, your posts are so inspirational…you have helped me to stay strong through my journey. Thank you so much for sharing yours!
Be well,
Vicki
2007: lumpectomy, Taxotere-Cytoxan
2009: mets mediastinum, Xeloda
2013: mets liver and bone, Gemzar, Zometa
Really excellent informative post. Your writing and handling of this whole experience continues to just blow me away. I don’t know that that is any consolation, but i think the effect you have on other people must be or else you wouldn’t do this. I’ll be thinking of you and keeping my fingers crossed.
thanks for the info, knowledge can be powerful. Good luck.
Terrific “awareness” for us all in a way only you, Lisa, can convey! Understandable scientific explanation with personal insights that can only come from an articulate patient. You are simply amazing on so many levels! There is not a big enough brown paper bag in the whole world to hold my hope for you! Much love and support…..
You should have been a science writer, Lisa. You make even the most obscure information accessible. Never stop.
I always appreciate your posts, Lisa. I’ve not commented before, but we’ve spoken on Twitter, and — you rock! I know you hate words like courage and bravery, but this clarity must take a deal of work. Well done.
Lisa, not only do you paint the picture of your experience in emotional terms, but you bring us all with you on the learning curve. Keep on writing, always – we are reading your words, hearing your voice and, of course, sending you hope and strength.
Thank you for being so explicit about your journey and for sharing comprehensive knowledge about the latest trials.
[…] it like to go through a clinical trial for a new cancer drug? Lisa Adams narrates her […]
It feels like such a privilege for you to let us into your most private thoughts and experiences. I love how you wrote about the mystery of what was held in the small brown paper bag. Through these next steps, I wish you the very best outcome and all the hope your heart can hold.
Kim
I’ve been thinking of you since I read this post last week and hope you are doing well. Just want to add to all the above wishes that this trial works for you and also thank you for the information about it all. Much appreciated. You are sent healing thoughts! (OK, and maybe a small prayer) Congratulations on the song too!!
My coping mechanisms are also research and action. Just read above that the tumor in my breast is the same morphology as yours Pr+ Er+ Her2-. At least when I go to the city I only have to ride in the car! Thank you for your blog, for your direct style. Thank you.
[…] York. Adams shared what it was like to go through the “washout” period leading into the trial, the science behind the compound, how she felt during and after treatment, and what it was like for her physically and emotionally […]
[…] York. Adams shared what it was like to go through the “washout” period leading into the trial, the science behind the compound,how she felt during and after treatment, and what it was like for her physically and […]
[…] of the scientific reasoning behind both her standard and experimental treatments. Start with “Clinical trial including GDC-0032: cycle 1, day 1” to follow one of her experiences throughout one trial, from beginning to […]
I had 21 lymph nodes removed along with my left breast april 1 2016. and my surgeon said if I let anyone do any blood pressure checks or blood draws on my left arm, she would sew the stuff back on. the lymphedema isn’t painfull at all. just inconvienent since I am left handed.