No enrollees in clinical trials, no cure anytime soon
Or maybe I should have titled this "Too Few Enrollees, No Cure Anytime Soon."
Every drug that is currently available has undergone rigorous testing on clinical-trial volunteers. If cancer patients don't volunteer to participate in trials, there will likely not be a cure for any of the many types of cancer anytime soon. But according to the National Breast Cancer Coalition, less than 3% of the population of active cancer patients do enroll.
http://www.breastcancerdeadline2020.org/breast-can...
It is important for everyone to understand - especially "newbies" - that your oncologist will not necessarily recommend a clinical trial for you.
Many oncologists just administer standard-of-care treatment, which is pretty much the same across the country (surgery, AC+T chemo, radiation), and that's it.
Sure, if there is some trial going on at the clinic or hospital where you are being treated, then he or she may suggest it for you. That's in house.
But it's very unlikely you will be directed to a clinical trial at a cancer center across town or in another town or in another state. Cancer is a retail business. Your oncologist is probably not interested in sending you, the customer, elsewhere.
Plus, sadly, many oncologists are 9 to 5 'ers. They don't really understand the science and don't really care to. They don't make sure to stay informed about the hundreds of breast cancer trials going on around the country. All they have to do is follow the ASCO guidelines for standard of care. And when treatments are no longer working, they say, "Sorry, there's nothing more we can do." (Not all - some are great and really interested in the science of cancer and in scientific advancements. And some really do fight for the survival of all their patients rather than just writing them off when treatments stop working.)
If you are interested in participating in a clinical trial, either to advance science or to try to give yourself a better chance of surviving, in addition to asking your oncologist if they know of any trials that would be good for you, you might also want to read up on available trials, find a trial that might be good for your situation, pick up the phone, and make the call to the trial contact yourself.
It will not mean that you cannot still be under the care of your current oncologist. You just might want to inform him or her that you are doing a trial and and keep him updated. (Or not.) And you don't have to be a patient at a clinic to enroll in a trial that that clinic is offering.
You can do standard of care with your oncologist and then go elsewhere to get on a trial that might help prevent recurrence. Or you can find a trial that includes standard-of-care treatment (plus more new therapies) from the get-go.
Clinical trials are not for everyone. It's a personal decision. Not everyone has the time and resources I know. And trials are not always without risk, especially phase 1 trials, which are small trials that test new modalities and therapies for safety, side effects, and for dose escalation. However, in the U.S. in particular researchers and doctors take the "do no harm" mantra extremely seriously. It's one reason progress has been so slow.
I personally wouldn't hesitate to enroll in a phase 1 trial if I found the right trial at the right time. (I've already participated in one vaccine trial. But I'm currently in treatment with my oncologist and I want to give what we're doing a shot so I can't do anything else right now. But I keep an eye on the trials all the time.)
http://www.futureofpersonalhealth.com/education-an...
Phase 1 trials are very small (under 20 people usually) and testing for safety, side effects, and dosages. Usually offered at only one location.
Phase 2 trials are bigger (but still under around 50-75 people?) and are designed to test for response in humans with cancer to a therapy. They usually have a placebo arm. So half the people get the therapy and half don't. Still usually offered at only one location I think, or by one clinic with multiple locations (such as Mayo Clinic with its three locations).
Phase 3 trials build on phase 2 trials. They seek to enroll hundreds or thousands of patients. Sometimes they tweak the therapy or the patient population to optimize results, based on what they learned in the phase 2 trial. Also usually or often has a placebo arm. Usually offered at many locations and clinics across the country.
If you are a cancer patient and you can enroll in a trial and it's something you are interested in, I encourage it. You will be helping to advance science in a way that no one else can. And you might even be helping your own cancer case or even saving your own life! Think of the people who volunteered to test Herceptin many years ago.
Mainly I want especially newly diagnosed patients to understand that you can't rely on your oncologist to get involved at this level. It came as a bit of a shock when I figured this out near the beginning of my journey. You have to be your own advocate.
Edited to add: Several people mention out-of-pocket costs or insurance costs to the patients of clinical trials. My vaccine trial was totally free to me. No one asked me for any payment of any kind for any part of it. I admit I always assumed all or almost all trials are free to the patients because the trial leads typically have to gather funding in advance. Or many trials are initiated and funded by pharma companies.
I guess if you inquire about a trial it's a good idea to ask if it's going to cost you anything or if your insurance will be billed for anything. I don't know what percentage of trials incur charges to the patients but I'd love to know. It's something you don't hear much about. But please don't assume it will cost you anything out of pocket.
Edited to add: http://www.medicalnewstoday.com/articles/304607.ph...
An estimated one-fifth of cancer therapy trials fail to enroll enough patients and are halted as a result. Also, patients who are involved in clinical trials have better outcomes.
Comments
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Could not agree with you more. I would shout this from the cancer centers' rooftops if I could.
I am in 3 clinical trials. I will always do what I can to participate not just for my health but for others to come.
My thoughts and feelings have always been if it weren't for the women before me who participated in the Herceptin trials would I even be here today?
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One of the big issues with clinical trials is out of pocket expenses; there may or may not be expenses and it's hard to know exactly how much they will be. Many insurers do NOT cover experimental treatments.
I am in a clinical trial at this time. My insurer has refused coverage (through 3 appeals, which was wearing and discouraging) so we do have on-going out of pocket expenses. I'd LOVE to see groups such as the ACA or Komen help cover expenses for women in clinical trials but am not holding my breath!
PS - I'm not stage III so apologize for intruding on your forum but the topic is one I have (too much) experience with and feel strongly about.
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Yes, I'm all for clinical trials. I am starting my second one soon. I like the frequent follow-ups and my MO and clinical oncs are communicating so I appreciate the input from both to better treat me.
Hopeful, I did not know that there were some out of pocket expenses for some clinical trials. I thought they were funded. Well, I learn something new from you ladies everyday! And yes, thanks again to the Herceptin ladies who particiapted in the early trials!!!
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Sorry but unless someone comes up with a way to fund living expenses for us to enroll in trials then the bottom line is there will never be enough patients to enroll. No one would like to see a cure more than we Stage IVs but we're tapped out and many of us have been tapped out for years - all this "pink" fundraising money is going into a black hole because there is no funding available.
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Clinical trials are not the only things we can volunteer for. I'm currently taking part in a nurses study at Vanderbilt tracking those who do and do not experience lymphedema after treatment of BC. Many teaching hospitals have studies going on. Mine requires filling out a survey several times a year and having detailed measurements taken regularly. The nurses doing the study have told me they have problems getting enough people to volunteer and to stay with the study, especially those not experiencing problems. It is kind of a pain, mostly I just want to leave after my doctor appointments, not stick around to see the "lymphedema girls" but hopefully their study will lead to a better understanding of lympedema, who gets it, why and how to best manage it.
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They have a similar lymphedema study under way at the teaching hospital where I am being treated. Since the docs are almost always running behind schedule they send patients to take measurements before doctor appointments. It only takes 2-3 minutes.
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I am a 2x breast cancer survivor and a patient advocate. So much so that I have dedicated myself to learning more and educating myself as well as other survivors about what treatments are or should be available to patients. There is a whole world out there of studies going on that I feel doctors are not supporting or telling us about. We have to stand up and do the work, for us and those that cannot or are to sick to. I am now working for a tech company that is helping patients find and connect with trials - I feel I have to do this - I have to get active and do it for me, for my children and for you. After all we have to be our own best advocates who else will watch out for us if not ourselves.
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And don't forget to enroll in the Army of Women. Here's a thread from 2008 (when the "Army" was started). There always seem to be breast cancer-related studies that can't reach the level of significance because they don't have enough study participants. The Army addresses that need.
The idea is that a pool of women (both with and without breast cancer) are willing to receive emails about the need for volunteers for screened research studies. When you receive an email, it tells you what's needed and where. If it's a study that you'd be interested in, then you reply to the email and they give your contact details to the researcher.
It's something we can do (and that our family & friends who don't have BC can do) to help advance BC research. I've been getting their emails since 2008...it isn't oppressive, since the studies are "approved" by the Dr. Susan Love organization before they are sent.
They were (are) looking for a million members. They're still under 400,000. We can boost that number!
Are you currently a member?
LisaAlissa
PS: Here's a list of (now closed) studies that the Army and supplied participant names for...interesting to see the sorts of studies that they send emails about.
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I was able to be assigned to a Clinical Trial "navigator" much like a Nurse navigator. I found mine by inquiring about studies related to Lobular treatment at University of Pittsburg - a leading research facility for Lobular breast cancer.
Thanks to this website and other sources, I rejected Standard treatment beyond surgery and Femara. Research shows little benefit for TAC chemo, and Lobular cancer metastasizes so how effective is radiation? Radiation also causes cancer.
I'd recommend to anyone to get their own clinical trial navigator. Large research facilities or the American Cancer society may be sources. I've finding being stage III frustrating, as most clinical trials want stage IV, so I feel I have to wait until a recurrence to get better medications. Once in a while a study does come along, and it helps to have someone besides your Oncologist looking out for you
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I'm involved in a couple clinical trials. This is great information. Thanks!
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I would love to participate in a clinical trial, but there is nothing here in central california
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As far as I'm aware there's never been a trial accepting stage 3 men.
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I think the sad part is when we are offered trials at early stages - we can take something that may have unwanted side effects or (?) when it's shouted from the rooftops how stage 1 is 90% "curable". I declined a trial because the drug (Xeloda) is known to cause diarrhea. Yes I was offered at stage 2b before neo adjunct chemo and after surgery restaged at 1b. Why take something that would impact my ulcerative colitis or shoot the rapids with a 90% plus cure rate. Well, there I was 3 years later in the bottom 10%.
Now after surgery, more chemo, arimidex, I still turned down Xeloda because it's 50/50 that BC it will come back vs. VERY likely + chance of my UC acting up and loosing my colon (I've had UC for 25 years with mostly good control over it). What? Lost my boobs, ovaries, uterus, hair, now I get to poop in a bag the rest of my miserable worried life? Pick your poison. Please don't scold us who have turned down trials! -
Thanks TS there has indeed been a tectonic shift in ungendered drug trial inclusions for late stage bc. Still looking for my study though.
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"Plus, sadly, many oncologists are 9 to 5 'ers. They don't really understand the science and don't really care to. They don't make sure to stay informed about the hundreds of breast cancer trials going on around the country. All they have to do is follow the ASCO guidelines for standard of care."
couldn't agree more.....I find I know more than most oncologists....being your own advocate is a necessity....not a maybe.
Jacqueline
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YATCOMW that is a scary thought. My guy is one of the top guys in the area, in on alot of research, committees etc. His personality is so so but I didn't hire him for that. He's adjusted some and so have we (my husband and I). I shudder at the thought of any 9 - 5 oncologist!
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And when family members/friends ask what they can do...one thing you can say is "Join the Army of Women and read the emails!" Many researchers have promising studies which have been approved, but they aren't able to get enough participants who fit their study design. So the research is never completed. The "Army of Women" is intended to help such researchers recruit sufficient participants to complete their promising research study! (You never know, maybe one of these will give us a huge advance?)
"Here's a link to their FAQ page" for more information.
Note several things:
There is no cost.
You'll get blast emails about pre-screened studies. If you see a study that you like, you can say you'd like to participate and be instructed how to get more info to see if you're a good match.
They need both healthy women and women with BC--so your family and friends can join.
They would also like men with BC or men who have had immediate relatives who've been diagnosed with BC (see the FAQ).
This is a way to make sure studies with promise don't fail for lack of participants.
Read...and join!
LisaAlissa
etc: link to their FAQ page, as the link address has changed.
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Thanks LA I signed up for AOW. Not thrilled that the site text pretty well ignores guys with the disease, but the FAQ says men are welcome.
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Clinical trials are a joke around here. None discussed with my wife. When I made inquiries with "Cancer Care Manitoba" about clinical trials, I got no reply. The Doctor in charge of a major clinical trial was in fact pessimistic on the outcome, and the trial of cdk4/6 inhibitors here never came to be. Pathetic.
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Husband11: Trials are a joke here in the US too. Cancer is BIG business dollar wise -- every form of it, therefore, we will probably never see a cure for any form of it anytime soon or even decades from now. Pathetic is the right word !
Even last year when my husband was undergoing treatment for lung cancer, the immunotherapy "Opdiva" is not effective when the patient has prior history of auto-immune disease. In his case he had diabetes and RA, so the treatments did nothing. I can't imagine that is the best they have even now.
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Clinical trials are not the only step in the research and development of treatments. They are a critical piece but not the only piece. Seeing progress and success are not guaranteed and this makes it very difficult and disheartening. Especially when you're loved ones or you are participants or hopeful recipients of the results.
I believe that by not trying to recruit participants for clinical trials, physicians are creating a disservice to their current and future patients. Hopefully people can be exposed to these opportunities through social and support networks. I was lucky enough to chose my care to be done through a research medical facility so opportunities for clinical trials were more available. But I know that others are not so I will continue to help try to promote threads like this and educate people on their opportunities.
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bumping. So important...
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