Considerations for Enrolling into a Clinical Trial


Valerie Frank and Sara M. Tolaney, MD, MPH, share advice for patients on managing treatment with antibody-drug conjugates and the importance of participating in clinical trials for HR+/HER2- metastatic breast cancer.


Valerie Frank: So then we made this change and then that's when we started talking about this trial. And so it's for Sacituzumab and immunotherapy. And I placed a lot of my hopes on the immunotherapy. And I really wanted it and I knew I had to be in the trial to get it. And I had to go through a liver biopsy to qualify for the trial and do a whole bunch of other things that I can't remember because I was stressed out and then I did not get it, I did not randomize into the arm with the immunotherapy and it happened in a kind of dramatic fashion because I was really waiting for the call to be told whether or not I got randomized in and I was in a waiting room to have like my hair shaved off because it was starting to you know, fall out I was basically getting my hair cut super short so that I could start this sacituzumab and I got the call when I was in the waiting room of the hair place and I fell on the floor like I had just been told the worst news of my life. I mean, I was in a heap on the floor crying when I found out that I didn't get the immunotherapy and I called the hospital and I wanted Dr. Tolaney to call me in to talk about it. And, you know, she called me and told me she says she was mad. It's a really good drug even without the immunotherapy. And this is, you know, you're getting good, good medication. But I was I was really, really devastated. I was angry not at any one but at the situation. And, and I just felt like

I could cry right now thinking about how bad it was.

Dr. Sara M. Tolaney: I mean, it's nice to be able to kind of hear your take on it. Because I think this comes up a lot when we do clinical trials, particularly when they're randomized, where it's out of all of our hands. Anyone is going to get in, I think as a patient to get told you're getting one arm versus another, I think is obviously very difficult in this case, just so that people are listening understand. This is a randomized trial of Sacituzumab and with or without pembrolizumab and the idea. The question that (gets asked) is if you add the immunotherapy is that going to make the sacituzumab better? And Valerie's case reason we were also so interested in immunotherapy.

I think why it was particularly hard when Valerie found out about the randomization was that her tumor also has a high tumor mutation burden. And so it made us think that there, you know that the immunotherapy really could work and it could add, you know, we did discuss it, we certainly could give immunotherapy by itself. But I liked the idea of trying to give it with something to make it work potentially better. And so like both Valerie and I were hoping for the combination arm and so I think it was, I think very difficult.

I think the other thing is, Valerie has beautiful hair, and very, very beautiful. And she knew it was a big change because we were going from you know, hormone therapies to Xeloda where she didn't lose her hair. And then here, you know, she invested in going into trial where she knew, regardless of what arm she was on, that she would lose her hair too. And well, you know, she was OK with that and knew that was going to happen. I think it's still devastating when it does happen. And, you know, here she is going to get her hair cut short to undergo hair loss and then being told that she didn't even get the arm of the trial that she wanted. And you know, it's hard and have evaluated persevere. She went on to decide she was debating truthfully if she wanted to continue on the trial or not. And after hearing that, because I think it's hard. It's a very hard adjustment. And, you know, I think we both decided that saskatoons was a good drug and we know it works and hormone receptor positive disease. We were just using it a little earlier than the approval currently is. It so she did start on it.

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