Courtney Collen (Host): Welcome to this episode of the One in Eight podcast by Sanford Health. We are continuing an important conversation about breast cancer as one in eight women will be diagnosed with breast cancer in her lifetime.
Sanford Health has a new option for patients diagnosed with breast cancer, the I-SPY 2 trial, which is being called the most efficient clinical trial platform available. Today, I’m joined by Dr. Amy Sanford, a medical oncologist and hematologist who specializes in caring for patients with cancer and blood disorders. She’ll tell us more about this trial.
Dr. Sanford, welcome.
Dr. Amy Sanford: Thank you.
Courtney Collen (Host): Thank you for being a part of this conversation. What is the I-SPY 2 clinical trial?
Dr. Amy Sanford: So I-SPY 2 is a unique trial design. It is a phase II platform trial that is studying drugs in the neoadjuvant setting for patients with locally advanced breast cancer. Essentially what a platform trial is, is it looks at multiple different drugs all at the same time in parallel. Most standard trials look at one drug at a time. And so this is really unique in that it can study up to six different drugs all at the same time.
Courtney Collen (Host): Wow.
Dr. Amy Sanford: Yeah. And so the, you know, the unique part of that is we can look at different drugs in the neoadjuvant setting, which is essentially chemotherapy before surgery. So women present with locally advanced breast cancer. The standard of care is to give them chemotherapy first to try and shrink that cancer and then take them to surgery. And the ultimate goal is for there to be no cancer at the time of surgery. And so on this trial women have the opportunity to see multiple different drugs with the hopes of achieving that kind of zero residual cancer.
Courtney Collen (Host): Let’s talk about who can participate in this specific trial.
Dr. Amy Sanford: So this trial is for men or women. Obviously we see more women, anyone 18 years of age, who has an invasive breast cancer. That’s at least 2.5 centimeters in size is a stage two or three. And there are some additional features of the individual breast cancer itself that we have to meet criteria for, so, larger locally advanced breast cancers.
Courtney Collen (Host): How can one of those patients enroll or get connected into this trial?
Dr. Amy Sanford: So anyone who has interest in any trials, especially I-SPY, should contact Sanford Health. You can schedule with one of our medical oncologists. You can self-refer; if you’d like you can have your primary care doctor refer. If you have questions just about the trial itself, whether or not you’d qualify, you can contact our research team and they can go through some of your specific cases, some of your specific details and make sure that you would be eligible for the trial.
Courtney Collen (Host): Let’s say I’m a patient who is interested in this trial and I qualify. Walk me through the steps, what I can expect from start to finish.
Dr. Amy Sanford: On trial there’s you know, different steps that we take. Obviously we need the original biopsy that confirmed your cancer. We need imaging including a breast MRI for this trial, because that’s how we look to see how the drugs are working. Each MRI along the way is measured to see how much residual cancer burden is there based upon imaging. So we do MRIs. There’s additional biopsies on the clinical trial. And then once we get all of that information, we determine whether or not you’re eligible. Then you get randomized to one of the arms and then we start chemotherapy as you would normally.
Courtney Collen (Host): Wow, okay. So talk about the impact now and the impact you hope for future generations of patients.
Dr. Amy Sanford: So the impact of the trial, you know, it’s potentially huge. As we talked about, it’s a platform trial, which studies multiple drugs at the same time. This in particular is a randomized adaptive trial. And so in real time, these drugs are being studied, we can measure the tumor shrinkage on MRI and at the time of surgery, we can see how much cancer remains or if there’s no cancer. That information is fed into the trials’ randomization engine and women have a higher chance of receiving one of the drugs that is doing better. And so women on the trial have a better chance of receiving drugs that are currently working better at eliminating breast cancer. And so that’s huge, you know. You have a better chance of getting a drug that works better than what we have now as standard of care.
Courtney Collen (Host): Is there any reason a patient wouldn’t or shouldn’t enter or be a candidate for this trial?
Dr. Amy Sanford: There are always personal reasons why people don’t want to enroll in clinical trials. You know, sometimes people worry that they’re being experimented on, which is not the case. You know, medically, there’s a few reasons why we don’t think people are eligible for trials. But aside from those very specific cases, you know, we welcome all participants on trial because this is not just how we learn in medicine, but this trial in particular actually gives each participant, you know, a chance of having a better outcome than they would standard of care.
Courtney Collen (Host): And being a part of medical science and research and improving care for the future.
Dr. Amy Sanford: Absolutely. Yeah.
Courtney Collen (Host): Incredible. As a physician, a medical oncologist hematologist, what is this like for you to be able to offer this type of trial here at Sanford?
Dr. Amy Sanford: So I-SPY is actually a huge opportunity for Sanford. Until very recently there were no community oncology centers that had this trial open. This is a larger trial across the country, really only opened in academic centers. They are now adding a few more community oncology sites, but Sanford has been – up until now – one of the few community sites that had the trial open. And so for women to receive cutting edge, you know, clinical trial care at home, you know, is huge for them.
Courtney Collen (Host): Is there anything else that you would want folks listening to know? Maybe they’re on the fence about participating or they’re just looking to get more information. What would you want them to know to maybe encourage them to be a part of this?
Dr. Amy Sanford: We’re always looking for better drugs and this is what that trial, you know, really gives women a chance to have access to better drugs, a chance, you know, even for future generations to receive less drugs. That’s what clinical trials are all about. We provide the same care for women on trial or off trial. There’s really no reason in my opinion, to be scared of a trial. You just have access to great drugs, potentially. A lot of trials, we can never tell individual participants you know, that they themselves would gain any benefit from it. You know, a lot of trials we study really for future generations. I-SPY is really for the individual woman, you know, who’s on the trial, there is a chance that they will benefit from the drug. And not obviously we learn always from what happens now on a clinical trial, but patients themselves can benefit from this trial, too.
Courtney Collen (Host): Is there anything else that you wanted to add?
Dr. Amy Sanford: No. I mean, if you have questions, concerns, certainly give us a call here at Sanford and we’re happy to see you.
Courtney Collen (Host): Dr. Amy Sanford, thank you so much for this information and a little bit more insight on the I-SPY 2 Trial here at Sanford Health. So lucky to have this as part of our care, and of course you on the team as well. Thank you so much.
Dr. Amy Sanford: Thank you.
Courtney Collen (Host): Thanks for being here. Stay well.