Being in a Metastatic Breast Cancer Clinical Trial

Welcome to The Breastcancer.org Podcast, the podcast that brings you the latest information on breast cancer research, treatments, side effects, and survivorship issues through expert interviews, as well as personal stories from people affected by breast cancer. Here's your host, Breastcancer.org Senior Editor, Jamie DePolo. 

Jamie DePolo: Hello. I’m Jamie DePolo, senior editor at Breastcancer.org. I’m podcasting live from the 2023 San Antonio Breast Cancer Symposium. My guest is Dr. Kelly Shanahan, an OB/GYN who has been living with metastatic breast cancer for 10 years. I’ve spoken to Kelly in the past and she always talked about how much she wanted to be in a clinical trial. She is now, and she’s going to tell us about that experience.

So, Kelly, how did you come to be in a trial?

Dr. Kelly Shanahan: Thanks, Jamie, for that question and the opportunity to speak with you and the listeners today. So, I was super lucky person who went many, many, many, many years without any progression, and then had my first progression. And I always talked to my brilliant MBC expert oncologist about trials that I might qualify for. But when I had that first progression two years ago, we decided to go on standard-of-care treatment with fulvestrant and palbociclib [brand name: Ibrance], which I did well on for, you know, 18 to 24 months, but started having little areas of progression.

And it was like, okay, now it’s time for a clinical trial. And I have the privilege of knowing oncologists all over the country through my advocacy work and I spoke to some other oncology friends across the country, and there were a couple of trials that looked interesting, but it would have required me to move, you know, out of California for a couple of months.

And my brilliant super MBC expert oncologist and I came up with a trial in San Francisco, a phase I trial that looks very promising. I reviewed all the data that’s published on anything they had done before and decided to enroll in this trial.

Now, it’s a phase I trial.

Jamie DePolo: Yeah, tell us what that means because I’m not sure everybody’s going to be familiar with that.

Dr. Kelly Shanahan: So, trials are different phases. There’s phase I…well, first there’s something called first-in-human which is usually super small numbers to make sure like, the medicine’s not going to kill you or turn you purple or something immediately. And then there’s the traditional phase I or Ib trial where they’re looking at…they’ve already figured out a dose they want to use from the very, very first-in-human stuff and animal model studies, and they administer this often with standard of care or, you know, occasionally it's you’ve been on one therapy and then they switch to this to see if it works well, and then they’ll move on.

So, often they’ll test the drug by itself, the investigational drug by itself, and then they might do another phase I trial in combination with an existing medication. 

And then it goes to phase II which is higher numbers of people. A phase I trial might have dozens of people enrolled, a Ib may have a few dozen people enrolled. A stage II, a phase II trial might have, you know, 100 people enrolled, and then when you get up to the phase III, the ones that are done in order to get the drug approval through the FDA, it’s hundreds or maybe even a thousand or so people.

So, I am in a trial where they combine the investigational drug with standard of care, either ribociclib [brand name: Kisqali], one of the CDK4/6 inhibitors, or alpelisib [brand name: Piqray], which is a PIK3CA-directed therapy that’s got some gnarly side effects. And even though I personally have a PIK3CA mutation, my brilliant oncologist and I were like, yeah, we’re not doing that. 

So, I am on an arm of the investigational drug which originally was called OP because of the name of the pharmaceutical company, OP-1250. They’ve now given it a name, palazestrant…

Jamie DePolo: That sounds fun to say.

Dr. Kelly Shanahan: Yeah. Which is not the brand, you know, obviously it’s not but if it’s approved it’ll eventually be the brand name, but so, I’m doing that in combination with ribociclib. I have completed two cycles and it’s interesting because I’m like, yeah, I want to do a trial, I want to like, participate, I want access to cool new stuff. I want to help other people that follow me, that’s really big for me, personally. But man, the logistics of being in a phase I trial.

So, when you have a new drug you have to see like, how quickly do levels go up? Do they stay up? How, you know, do they drop off at 12 hours? Do we need to give it twice a day? And then when you add another drug into it, you got to see if there’s any interaction. So, it’s called pharmacokinetics and so, it’s a blood test to look at these levels of the drugs, but they’re done frequently at a couple points. And when you’re in a clinical trial, there’s usually some very young person who’s the clinical trial coordinator that’s, you know, working with the clinical trial team at your institution to help you, the patient, negotiate and navigate all the stuff. 

Well, when your clinical trial coordinator graduated from college a couple months ago. You know, and again, this is institution to institution, may be very well-trained in oh, this trial we have to do EKGs, here’s how you do an EKG and they’re trained on that. Here’s everything involved in the trial, they’re trained on the protocol. They’re not often trained on the practicality. 

So, for example, the very first day I was going to take the drugs, you know, I had to go for a visit. I had to have fasting labs done, check cholesterol, check fasting blood sugar, check a whole like, seven tubes worth of stuff. 

Jamie DePolo: And this is a 12-hour fast when you say fasting?

Dr. Kelly Shanahan: Yes, a 12-hour fast. Okay, so, fine. I’ll go in at 7:30 in the morning, no biggie. But they can’t discuss the medication until I see the doctor. So, she’s like, oh, I got you your first, you know, first, you know, day one, and you’re going to see your brilliant MBC expert oncologist at one o’clock in the afternoon. And I went, um, so, I’m going to have to be fasting, get fasting labs done right before I see her. You do the first, you know, the EKG before I’ve taken anything. I then have to wait to see her before pharmacy will release the drug to me, and she’s never on time.

Jamie DePolo: And wait, this whole time you can’t eat either, right?

Dr. Kelly Shanahan: I still can’t eat. I’m like, do you want to be fasting from midnight until two o’clock in the afternoon? And then with this particular drug, it has to be taken on an empty stomach so, I can’t eat for an hour after I take it. 

Jamie DePolo: Oh, gee.

Dr. Kelly Shanahan: And then I said, Ann, do you really expect anybody from the lab to be there at oh, I don’t know, eight o’clock at night, to draw, because I had to have this pharmaco, the drug level pharmacokinetic test done before I took the drug, 30 minutes after, 60 minutes after, two hours after, four hours after, and six hours after. And she, poor girl, nothing like, having a doctor as probably the first person you’ve ever put on a clinical trial, and I’m like, yeah, I didn’t think so.

So, you know, next thing I know I’m like, first appointment of the morning, and we do this, getting all my blood drawn, and at the four-hour, right after they drew the four-hour mark, she comes in. She goes, the Biobank where we have to take these research specimens, they close at 3:30. 

Jamie DePolo: Oh, no.

Dr. Kelly Shanahan: And I’m like, soooo…and she goes well, you can leave now, and I’m like, yeah, I just got stuck again for nothing.

And you know, we found out that Biobank will stay late if you give them notice. So, you know, things are a learning process, but I do think that can make it, you know, why people may not want to do a trial. Also, I don’t live in San Francisco. I live Lake Tahoe, 200 miles away. 

Jamie DePolo: So, how does that work? Do you go in for like, a few days or…?

Dr. Kelly Shanahan: So, I’m very lucky. I have family members and friends that live in the San Francisco Bay Area so, I can stay with one of my friends. And I’ll go down the night before my visit, and then I’ll do the visit, and you know, sometimes I’ll stay two days if it’s like, we have to do another blood test the next day. But I have to go down once a week.

Here’s another thing about clinical trials. Most sponsors, i.e., pharmaceutical companies, will pay expenses like gas, like, if you’re flying in, your plane ticket, they’ll put you up. But they put that in really teeny, tiny print buried in the 40-page, you know, document you get. I knew this, but it was like, so, how do we do this? Like, how do we do this?

And so, you know, I’m fortunate, I’m privileged enough that I can pay for all this stuff up front. You know, 400-mile round trip, I live in the mountains, I have an SUV, 20 miles to the gallon, $5 a gallon. You know, it’s a hundred bucks every time I go down there. 

Jamie DePolo: And I want to back up just one second. You said the way it works where you have to pay up front and then get reimbursed? The sponsor does not provide you that cash up front?

Dr. Kelly Shanahan: Most sponsors don’t, but I listened to a webinar several weeks ago, a couple months ago, a researcher, I think at University of Alabama-Birmingham, who has got funding to do a study of people in clinical trials and giving them a stipend up front. And it’s a really interesting design because what she’s doing is like, we’re going to start off giving people $1,000 a month. And we’re going to query them on was this enough, was it not enough, and then after I don’t know, a month or I can’t remember the timeframe, we’re going to lower it a little bit, from $1,000 to maybe $800, until we find the point where the majority of people say, this is enough for me to participate in a trial without causing an economic burden. And I’m like, that is brilliant. 

Jamie DePolo: Yeah, that’s a great idea. So I have to ask, phase I trial, sounds like, the logistics are a little bit tricky. Are you still happy you’re on a trial, are you still as enthusiastic about trials as you were?

Dr. Kelly Shanahan: I think I’m even more enthusiastic about trials. I’m also really enthusiastic about setting up a meeting with the clinical trial training people at my institution.

Jamie DePolo: I bet.

Dr. Kelly Shanahan: And you know, helping them work through how to make it as patient-friendly as possible. How to make it easy. You know, to think about these logistical things which, you know, it’s true. I mean, until you do something, you don’t understand how the process works, and I don’t care whether it’s, I don’t know, sewing a dress for the first time or making, you know, veal cordon bleu or whatever. Until you do it and you walk through the process, you may not have an understanding, and that’s true whether it’s a researcher or a clinical trial coordinator or actually the patient. 

Jamie DePolo: Sure.

Dr. Kelly Shanahan: Yeah. 

Jamie DePolo: Yeah. Okay. I have one last question, then, too. To you, clinical trials are important. Tell me why everyone should think clinical trials are important.

Dr. Kelly Shanahan: So, none of the drugs that we currently take, including over-the-counter stuff like, aspirin, would be here if people hadn’t agreed to try this out in the first place. Also, if we don’t get enough people to enroll in trials quickly, it could be the most promising thing on the planet Earth, but they don’t get enough people enrolled and they have to stop that trial, that drug’s never going to make it to market. None of us are ever going to benefit from it.

And if only middle-aged white people participate in trials, we don’t know how the drug works or what side effect profile it has in Black people or, you know, Asian people or, you know, people of the diverse racial and ethnic backgrounds. We don’t know how it works in old people, and man, these clinicals need to stop defining old as 65 and older. The closer I get to that number I’m like, that’s not old. 

Jamie DePolo: Exactly. Yeah. No, everything you’ve just said is so true, and especially about the age because I know people think about ethnic-racial diversity in trials, but nobody really thinks about age, but yet, especially with breast cancer, you know, we’re talking 65 to 80-year-old, mostly women, and if those drugs aren’t tested on them, how do we know that the side effects are the same?

Dr. Kelly Shanahan: And how do we know that they work in conversely, the younger populations? You know, if you’re in a trial like, the one I’m in and you, you know, you know, you have metastatic disease, you have metastatic breast cancer, and you have a young family, and maybe you’re still working because you’re doing okay. Maybe you’re having some progression and it’s time to think about…it is always time to think about a trial. First line of therapy it’s time to think about a trial. Fifteenth line of therapy is time to think about a trial. 

You know, we have to make trials more accessible to people. You know, I understand that with what I’m doing that they have to do these very, very specialized, you know, pharmacokinetic tests that can’t be done at your local, you know, Labcorp or Quest. But I have talked to people enrolled in trials where they have to have a CBC, I mean, a complete blood count, anybody can do that. But the institution or the sponsor will not let them get it done locally, they make them have to go. Or, you know, you have to have imaging, and okay, you know, maybe your radiologists are better, but can’t we electronically send the images done locally and have it reviewed by a radiologist at the Mecca, you know?

Jamie DePolo: Yeah. Yeah. All very important points. Dr. Kelly Shanahan, thank you so much. It’s always a pleasure to talk to you, and I wish you much success on your trial.

Dr. Kelly Shanahan: Thank you, Jamie. Always love seeing you and talking to you at the best breast cancer conference in the world.

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