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Clinical Trials for Triple-Negative Breast Cancer

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Published on October 12, 2020

What Clinical Trials Are Available For Triple-Negative Breast Cancer Patients?

How can triple-negative breast cancer (TNBC) patients find clinical trials? What trials are available for early-stage TNBC patients? How do you know which trial is right for you? What are the differences between trials and standard care? Watch as TNBC survivors Ricki Fairley and Moira Quinn get trial updates from Dr. Sara Tolaney of the Dana-Farber Cancer Institute.

This is Part 3 of a four-part series. Watch Part 1 (Treatments for Early-Stage Triple-Negative Breast Cancer (TNBC)), Part 2 (Triple-Negative Breast Cancer Treatment Options By Subtype ) and Part 4 (Managing the Side Effects of Triple-Negative Breast Cancer) for more information.

This program is supported by an educational grant from Daiichi Sankyo. This organization has no editorial control. It is produced by Patient Power and Patient Power is solely responsible for program content. 

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Transcript | Clinical Trials for Triple-Negative Breast Cancer

What Trials Are Available For TNBC, Including Early Stage TNBC?

Moira Quinn:
What about women or maybe men, I guess, who are in very early stage triple-negative disease. What kinds of treatment options would you suggest they consider discussing with their doctors?

Dr. Tolaney:
There are lots of clinical trials in that setting for patients who are getting chemotherapy prior to surgery. Most of these trials are looking at either adding on a drug to the standard or substituting one of the standard drugs for something else. For example, Trodelvy (sacituzumab govitecan-hziy) is currently being studied in a preoperative trial for triple-negative breast cancer in a trial called the NEOSTAR study. That's an example of trying to substitute standard chemo with a novel drug, but I will say there are also a number of clinical trials in this setting as well looking at whether a different drug instead of Xeloda (capecitabine) should be utilized or even sequentially after Xeloda to give additional therapy and there're vaccine studies, there're novel immunotherapies, so lots of trials that are being done in women who have cancer that was left behind after surgery.

I think all of these things are very important to discuss with your oncologist in terms of, are there clinical trial opportunities for me and what would be the standard treatment? What would be the side effects from that standard treatment? How would the clinical trial differ if I did that and would there be additional side effects that could occur? You really have to weigh the risks and balances of each approach.

How Do I Know If A Clinical Trial Is Right For Me?

Ricki Fairley:
Doc, you've talked a lot about clinical trials and a lot of the research that's going on. How do you decide if you're going to go into a trial, do you ask your doctor, does your doctor tell you, how do you know about what's good for you? I know for African American women, it's very difficult decision to go into a clinical trial. There's a lot of fear about it. How do you know what's right for you and what to do about that?

Dr. Tolaney:
Yeah, no, I think it's really a very important discussion with your oncologist because I think you have to understand... In my mind, I think you have to understand what's the standard. If I didn't do a clinical trial, what would your doctor recommend in that situation? And what would be the side effects?

Ricki Fairley:
That would be what people would call a placebo, right? There's no placebo, like, you're not going to get a glass of water. You're going to get something. Right. 

What Are The Differences Between Trials And Standard Care?

Dr. Tolaney:
Right. You definitely will get treated. There's not that we won't give anything. You definitely... you want to know what's the standard treatment and then you want to know on the clinical trial, how does it differ from what the standard is? Are you substituting something in the standard regimen or are you giving me something extra? And then what is that extra drug going to do? What do they think the benefit will be from it? And what do they think the side effects could be from it? And then I think sometimes clinical trials involve a few more hoops to jump through outside of just the standard treatment.

Sometimes there can be a few extra visits. Sometimes there are required biopsies. Sometimes there are required research blood collections. You really have to understand what it is involved. For a lot of my patients can come from far distances, and so if there are more visits from doing the trial compared to the standard of care, sometimes that influences them. If they're going to have to drive into Boston multiple more times than they would have if they didn't do the trial, I think you want to understand kind of what the difference will be on your impact on your quality of life from doing the trial versus not. 

Generally speaking, though, I think a lot of trials offer access to drugs at an earlier time point than we can give them before they get FDA approved. For example, if you think about all the immunotherapy trials that have been done over the last few years, they've been giving a drug that's likely going to become a new standard of care for patients and so that gave them access to that drug before it would become a standard. There definitely are some significant advantages to doing trials, but there also can be some disadvantages, again, sometimes more visits. Sometimes there are required research biopsy.

Sometimes this can add financial costs because if you're driving into Boston, let's say more times and you're paying for parking more times or your transportation is costing you to come back and forth. That can add cost, and so I think you have to factor all of these things in when making these decisions.

Excellent question. I will say it's very much dependent on the specific trial and setting of the trial. Some studies will say, you cannot have had another cancer in the last three to five years. Some studies take into account what kind of cancer it is and sort of based on the risk of that particular cancer, and some trials will be okay with it. Again, depending on the type of cancer and the timeframe. It is a specific question to a specific trial.


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