DR LOVE: Could you talk a little bit about the just-published, so-called MINDACT study looking at the 70-gene signature, what they looked at there and what you think it means?

DR GOETZ: Yes. So the MINDACT obviously was an important study that looked at this issue of so-called clinical high risk and genomic low risk versus the opposite — that is, genomic high risk and clinical low risk. And, obviously, in this particular study one of the things that they wanted to identify is whether those patients that are genomically low risk but clinically high risk could avoid chemotherapy.

And so, as you know, this particular study offered patients who were clinically low risk and genomic low risk endocrine therapy. And those patients that were clinically and genomic high risk received chemotherapy. And it was those patients where there was a difference between those 2 or, if you will, a discrepancy between those — that is, clinically high risk and genomic low risk or vice versa — who were randomized to receive chemotherapy or not.

And the primary endpoint of the study was just to be able to identify those patients that were genomically low risk but yet clinically high risk that they actually had a distant disease-free survival that was acceptable. And the primary endpoint of the study was met.

Now, I think that, interestingly, about this particular study — and that is obviously, the Recurrence Score is something that we’ve gotten and we’ve become quite accustomed to use here in the US. And I think the question, as I talk to my colleagues about these data, is, will these data really change our practice such that we’ll begin to use the 70-gene assay over and above the Recurrence Score?

And most people that I’ve spoken to have suggested that probably at this point that although these data are important — they are clearly Level A or Level 1 data — that they’re probably not enough in their minds to change what they’ve been using already, which is the Recurrence Score. But, clearly, there are enough data that I would say that if a clinician wanted to use the 70-gene assay that this would clearly be acceptable and would be supported by the data that was published.

DR LOVE: So in terms of the way you saw those data, I guess one of the questions is, are they able to identify patients with, quote, high-risk disease clinically, which really to a great extent means node-positive, whose prognosis is so good that really you couldn’t improve it that much with chemotherapy? I guess maybe in the range of 5% recurrence or not. Do you think that they demonstrated that?

DR GOETZ: Yes. I think that, as you know, in that particular study, there was still a small benefit of chemotherapy even in these clinically high risk, genomically low risk. But the delta, or the absolute benefit, was actually quite small. And I think that these data will need to be placed, obviously, into the context of the upcoming — or the data that have not been published, but we’ll hopefully have soon from the RxPONDER study. The interesting thing about the MINDACT trial was, they included both the node-positive and node-negative patients. And so we can clearly now say that there are Level 1 data for this group of patients.

Early-stage breast cancer (BC) in the adjuvant and neoadjuvant settings

Genomic assays and (neo)adjuvant treatment decision-making

Management of metastatic BC (mBC)

CDK4/6 inhibitors for the treatment of BC

Novel approaches under investigation in BC