The ASCENT 3 Trial of Sacituzumab Govitecan for TNBC


An expert oncologist highlights the importance of discussing clinical trial options with patients and comments on the recent FDA approval of sacituzumab govitecan in triple-negative breast cancer based on the ASCENT 3 trial.

Aditya Bardia, M.D., MPH: In terms of making a decision, it’s good to have options. That’s the role of the provider, to help guide the patient through different treatment options. In your case, there were a couple of options. One option was a clinical trial with a drug called sacituzumab govitecan. At the time, it was not FDA approved. Now it’s FDA approved. The drug is called Trodelvy. So there was a clinical trial with that drug. There were also a couple of standard chemotherapy options available. Why did you decide to participate in a clinical trial in a new institution with a new provider versus receive standard chemotherapy closer to home?

Latasha Jordan: It was a hard decision. I am on this journey and I’m fighting this fight. I know I’m not alone. A lot of decisions I made had everything to do with my faith. I prayed a lot. “Where will you lead me?” Do you know what I mean?

Aditya Bardia, M.D., MPH: Yes.

Latasha Jordan: As I said, when I met you I didn’t have any worries. There was no reason for me to worry about anything. I trusted the first team I was with. I knew that team was not going to just hand me over to anyone. My doctor could’ve said there was nothing else they could do and left it at that. She didn’t do that. She handed me to you.

The work you do is great. When I was diagnosed a second time, I thought, “I have to run and fight even that much more.” Whether the fight is a day or a week or a month, no matter how long a person fights, if they are tired they can no longer fight that fight. I felt like I had all of that energy within me, and I had God standing beside me. So I felt like I could grab all these torches and run with them. Do you know what I mean?

Aditya Bardia, M.D., MPH: Yes.

Latasha Jordan: I felt like this journey is not just mine. It’s everyone’s. Even for people who passed on, their torches are still burning. You’re not forgotten. I don’t know who they are, but we’re all together. They’re running with me. I don’t even know how to explain it.

Aditya Bardia, M.D., MPH: You can see the path and the light. Let’s talk about the second diagnosis. It’s almost like deja vu. It’s similar to the post-traumatic stress disorder feeling, where things are coming back again. It’s a flashback. But you handled it very well. I think part of the reason you handled it very well was you had a clear idea of, “This is what I’m going to do. I’m going to go to MGH [Massachusetts General Hospital].” You took your time, but you came to MGH and met with the team and made the decision of, “I’m going to move forward with the trial.” In general, that’s why clinical trials are done, to improve the field and to provide access to therapies that are otherwise not available. In your case, you got access to a treatment that subsequently got approved. But you were able to get access to that drug even before approval because of participation in the clinical trial.

If we talk about management of recurrent triple-negative breast cancer, we would call it metastatic triple-negative breast cancer if the tumor is outside of the breast. In your case, it was in the lungs. Management depends on a couple of things. First is additional evaluation. Even triple-negative breast cancer has been divided into PD-L1 [programmed death-ligand 1]–positive and PD-L1–negative triple-negative breast cancer. PD-L1 is something we look at in the biopsy, because that can predict response to immunotherapy. If it’s present, we know that the tumors would respond to immunotherapy. But for the PD-L1–negative group, it’s usually chemotherapy.

Now we have another treatment option. This may be called an antibody-drug conjugate, or targeted chemotherapy, or smart bomb. These are all terms that are used. The idea is you have an antibody with chemotherapy linked to it. The antibody finds the cancer cells, gets attached to the cancer cells, and then, in a focused fashion, delivers chemotherapy to the cancer cells but not so much the normal cells. It’s a way of giving high doses of chemotherapy to the cancer cells but not the normal cells. So, you have better efficacy with this concept. Trodelvy is the first antibody-drug conjugate approved for patients with metastatic triple-negative breast cancer. In April of 2021, the FDA granted full approval to Trodelvy. That was based on the ASCENT trial and participation of women like you in clinical trials who had faith that this could be a good option. Many times, not only do you help yourself, but you help the next generation by advancing research and advancing the field.

In general, in terms of the management of metastatic triple-negative breast cancer, options include standard of care chemotherapy or clinical trials. We strongly encourage clinical trials, especially with novel therapies, because clinical trials provide access to drugs that are otherwise not available and may help advance the field. Latasha was able to get access to a drug called sacituzumab govitecan, or Trodelvy, which was not approved but was available in a clinical trial.

From a patient perspective, I think it’s important to discuss both standard of care and clinical trial options with the oncologist. Clinical trials need not be restricted to the trials that are open in one institution. Like in Latasha’s case, her doctor looked at all possible options and knew that sacituzumab govitecan was a drug that had shown promising results. There was a trial available at Mass General Hospital, so she referred Latasha to Mass General Hospital. I think that should be acknowledged. I think her doctor did the right thing by not restricting treatment options to one institution. “What’s best for Latasha? Let me see.” Then, “How can I provide Latasha access to that drug without the confines or restrictions of an institution?”

Transcript edited for clarity.

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