TROPiCS-02 Study Overview and Patient Baseline Characteristics
Dr Tolaney discusses the TROPiCS-02 study design and comments on the key baseline characteristics of the patients with HR+/HER2- mBC who were enrolled in the trial.
Dr. Sara Tolaney: Because there was some original data in the phase 1 basket studies suggesting that Sacituzumab not only had benefit in triple-negative disease but actually also had benefit in hormone receptor-positive breast cancer, this study TROPiCS-02 was conducted really to look at the efficacy of Sacituzumab in pretreated metastatic hormone receptor-positive patients. It was for patients who had metastatic disease, had two to four prior lines of chemotherapy in the advanced disease setting. Again, very pretreated, they were required to have had prior taxane, prior endocrine therapy and prior CDK4/6 in inhibition and then got randomized to get Sacituzumab or to treatment of physician's choice therapy, where you can see the choices included, eribulin, capecitabine, gemcitabine or vinorelbine. The primary endpoint of this study really being progression-free survival. What we saw was that this did in fact enroll very heavily pretreated patients where in fact, again, you could see that these patients had received multiple lines of prior chemotherapy. In the metastatic setting, it was actually a meeting of three prior lines overall, and again, all patients had received prior CDK4/6 and almost all patients had visceral metastases. Here you can just see again that the number of lines of therapy in the metastatic setting, again, the median in the metastatic setting was three where you see about 60% of patients had had that.
