Evaluating Clinical Trials in Triple-Negative Breast Cancer


Kristie L. Kahl: Why is it important for patients to consider joining a clinical trial?

Dr. Ogori Kalu: Well, you know, in particular, for triple-negative breast cancer, we do know that it is the one form of breast cancer that currently standard of care treatment is not necessarily a targeted therapy. Well, maybe what I mean (by) targeted therapy is something that is specific for the triple-negative breast cancer. So that's kind of also what contributes to the higher mortality rates because we do not have targeted therapies. And that's where clinical trials come in, there are a number of clinical trials across the country and around the world that are occurring right now for triple-negative breast cancer from the earliest stages through to metastatic or recurrent triple-negative breast cancers. So I think it's very important for women who are diagnosed with a smaller cancer to investigate because the standard treatment option that we have right now, it's good, it's all we have. But there are things that are on the cutting edge that might be of more benefit to these women and contributing to the clinical trials, which of course, could benefit that patient as well as other patients in the community.

Kristie L. Kahl: If a patient is interested in joining a clinical trial, how can they learn more or even find out if they're eligible for one?

Dr. Ogori Kalu: Well, first, we can always start with their provider. Once they're diagnosed, I'm sure they will be referred to a medical oncologist and that medical oncologist would be the one who would actually know whether that patient is eligible for one if there's one within their community or one within a local institution itself or a local cancer center within their region. For the patients who may not have a medical oncologist who might have that connection into clinical trials, you can always go online. The National Institutes of Health has the clinical trials.gov online, which has a whole host of hundreds of clinical trials that are available to people and you can skim through that website. Honestly, the website is a bit daunting even for myself as a professional. So there are some more user-friendly, patient-friendly websites that are available for patients with triple-negative breast cancer. One of them is citizen.com, where the patient is allowed to just plug in their demographics, their information, what their type of cancer is, and then the program will just sort of show them which clinical trials they're eligible for around the country. The same for another website, called centerwatch.com. They do the same thing. It's more user-friendly, it's easier for the community to go in. And so there are a host of different resources that patients can go online, and they can have clinical trials that there actually are eligible for made available to them and see if they actually can become a part of it.

Kristie L. Kahl: Why is it important that patients talk to their doctor about potentially joining a trial?

Dr. Ogori Kalu: So clinical trials basically are trying to investigate some sort of new treatment for cancer, for a particular kind of cancer, particular kind of ailment that could benefit that patient's disease process in a better way than the standard treatment they already have. So it's always best to first go to your provider to actually know whether or not considering whatever clinical stage you are, wherever you are in your process and treatment, that it's appropriate for you to pursue a clinical trial, because of course, as a patient, your provider knows your health history the best. They know what's going on with you. They know what would be most appropriate and most beneficial for you. And they would be the first people you asked that question about clinical trials. They may not have all the information.

So the second tier, of course, is to do your own research. Because, you know, we can't deny that there are some parts of this country where access to aspects of more elaborate cancer care or more in depth cancer care may not be easily there for them. So sometimes, unfortunately, the onus is on the patient themselves to do that investigation. But always bring it to your physician first and ask those questions. Especially before pursuing any other kind of treatment than you're already provided with at that time.

Kristie L. Kahl: Can we also negate some of the misconceptions that we have about clinical trials?

Dr. Ogori Kalu: Only going to receive a placebo, the whole idea of the sugar pill, meaning really nothing, you know, for a person who has cancer, or any sort of life-threatening ailments. There are rules and laws surrounding medical ethics and the basic laws provided around a clinical trials that say we cannot put someone in a trial and not offer them treatment for whatever it is that they're going through. It's ethically unsound to do that. So the patient has to be reassured that whatever they're on the trial for, it will not take away from their primary treatment. So you'll either be in the arm where you're getting this or you're getting a new one, because it's always connecting, or comparing standard treatment to this new treatment that they're investigating. And that's one myth.

The other myth, of courses, (is that researchers) just want to experiment. This isn't of any benefit. It's just an experiment. Before trials get to the point of being used on human beings, they go through different phases and different approvals. It goes through different tiers before it actually gets to (the point where) we need patients to come in and actually participate in trials to see if it's effective. Again, there are rules or regulations that are governing clinical trials, so patients should not be (afraid) that (it) is just an experiment. I would get no benefit from this. Ultimately, there is a chance that this clinical trial medication won't be as effective than the traditional treatment that's offered. And that's something that you discuss with your provider or whoever is running that clinical trial prior to starting, whether you want to take that chance of taking on this treatment that hasn't been fully analyzed, compared to what we know has some benefits. But we have to reassure patients that a clinical trial does not mean you will go without any treatment for your cancer.

Kristie L. Kahl: Are there any clinical trials that are in progress that we can tell our patient audience more about?

Dr. Ogori Kalu: Like I said, there are literally hundreds. Good question. Very loaded question. So for me to single out just one it just doesn't do it any justice compared to the others that are out there. But for the most part, I think in general, a lot of these trials are trying treatments that are more targeted therapies specific for the cancer that these patients are suffering through. Triple-negative breast cancer, we found is not just one form of cancer in and of itself. There are multiple different aspects, or mutations, within the cancer that designate a triple-negative breast cancer and all these different molecular mutations are potential targets for treatments. And they're all being entertained or investigated as possible treatment options for patients. So, you know, just to let the public know, hundreds are being tried right now. And I firmly believe within the next few years, we're going to have a significant breakthrough in regards to treatment, medical treatment for triple-negative disease.

Kristie L. Kahl: To bring it all together, what would you say is your biggest piece of advice for a patient who might be considering joining a trial?

Dr. Ogori Kalu: I definitely encourage it. I believe that we should all try and do our part in contributing to science and in contributing to finding basically a cure for this disease process. And part of our contribution is joining clinical trials. If you're interested in pursuing one, my first and most important thing for any patient to do is to write out a list of questions. Constantly ask questions, Never go into a clinical trial blindly and say, “Okay, I'll do whatever you say.” Always be prepared or try and prepare yourself on what to expect. Ask the person who's organizing the trial, what are the expectations? What could possibly be the adverse reactions? And how long will I be on this trial? Is this trial something my insurance covers? Or is it something that they're covering as far as the institution who's running the trial? Those sort of important questions. Because you don't want to get caught within the trial, and all these things happen and you're like, “Oh, wait a second. I didn't know this is something I have to think about.” So I think patients should just be fully informed before starting any clinical trial. And of course, you know, don't be afraid because it's your right as the patient to have all the information upfront before joining in but I wholeheartedly encourage women who are eligible to enroll in a clinical trial if possible, especially when it comes to triple-negative breast cancer.

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