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sacituzumab govitecan (n=267) vs. Standard of Care (SoC) (n=262)
randomized controlled trial
Sacituzumab govitecan
10 mg per kilogram of body weight intravenously on days 1 and 8 of each 21-day cycle
single agent chemotheraopy of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)
eribulin (1.4 mg per square meter of body-surface area in North-America or 1.23 mg per square meter in Europe, IV on days 1 and 8 of a 21-day cycle), vinorelbine (25 mg per square meter IV on day 1 weekly), capecitabine (1000 to 1250 mg per square meter orally twice daily on days 1 to 14 of a 21-day cycle), or gemcitabine (800 to 1200 mg per square meter IV on days 1, 8, and 15 of a 28-day cycle)
single-agent chemotherapy of the physician's choice (for comparator group)
mBC-Triple negative (TNBC) - 2nd Line (L2)
Patients with stable brain metastases for at least 4 weeks before treatment were eligible for the trial but were excluded from the primary end-point analysis.
open-label
88 sites in 7 countries (North America and Europe)
P3 / a hierarchical testing procedure (gatekeeping) will be implemented for testing the endpoints of PFS and OS in BM-ve population (without brain metastasis) then, in all population, in this order: - PFS in BM-ve (two-sided, at 0.05), - then if significant, OS in BM-ve (two-sided, at 0.05) ;- then if significant PFS in all pop (two-sided, at 0.05),- then if significant, OS in all pop (two-sided, at 0.05)
Even though, PFS and OS (both were part of the plan statistical analysis) were significantly longer in the sacituzumab govitecan group, in patients without brain metastases. However, the study was ended in March 2020, before the scheduled end date, therefore the results are not conclusive.
sacituzumab govitecan (n=235) vs. Standard of Care (SoC) (n=233)
randomized controlled trial
Sacituzumab govitecan
10 mg per kilogram of body weight intravenously on days 1 and 8 of each 21-day cycle
single agent chemotheraopy² of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)
eribulin (1.4 mg per square meter of body-surface area in North-America or 1.23 mg per square meter in Europe, IV on days 1 and 8 of a 21-day cycle), vinorelbine (25 mg per square meter IV on day 1 weekly), capecitabine (1000 to 1250 mg per square meter orally twice daily on days 1 to 14 of a 21-day cycle), or gemcitabine (800 to 1200 mg per square meter IV on days 1, 8, and 15 of a 28-day cycle)
single-agent chemotherapy of the physician's choice (for comparator group)
mBC-Triple negative (TNBC) - 2nd Line (L2)
Patients with stable brain metastases for at least 4 weeks before treatment were eligible for the trial but were excluded from the primary end-point analysis.
open-label
88 sites in 7 countries (North America and Europe)
P3 / a hierarchical testing procedure (gatekeeping) will be implemented for testing the endpoints of PFS and OS, in this order: PFS (two-sided, at 0.05), then if significant, OS (two-sided, at 0.05)
Even though PFS and OS (both were part of the plan statistical analysis) seemed to be significantly longer in the sacituzumab govitecan group, in patients without brain metastases. However, these results are not conclusive because the study was ended in March 2020, before the scheduled end date.
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