A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Conditions

PD-L1-negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative setting

Brief summary

PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death (whichever comes first).

Detailed description

OS is defined as the time from the date of randomization until death due to any cause., ORR is defined as the proportion of patients who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first) as assessed by BICR per RECIST Version 1.1., TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST Version 1.1., Incidence of treatment-emergent AEs (TEAEs) and clinical laboratory abnormalities., Mean change from baseline in the physical functioning domain of the EORTC QLQ-C30 at Week 25, TTD of fatigue domain of the EORTC QLQ-C30 is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (ie, ≥ 10 points worsening from baseline in the fatigue domain) or death

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Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGPaclitaxel 6 mg/ml concentrate for solution for infusion

DRUGCarboplatin 10 mg/ml concentrate for solution for infusion

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

DRUGGemcitabine 38 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death (whichever comes first).	—

Secondary

Measure	Time frame
OS is defined as the time from the date of randomization until death due to any cause., ORR is defined as the proportion of patients who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first) as assessed by BICR per RECIST Version 1.1., TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST Version 1.1., Incidence of treatment-emergent AEs (TEAEs) and clinical laboratory abnormalities., Mean change from baseline in the physical functioning domain of the EORTC QLQ-C30 at Week 25, TTD of fatigue domain of the EORTC QLQ-C30 is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (ie, ≥	—

Measure

Time frame

OS is defined as the time from the date of randomization until death due to any cause., ORR is defined as the proportion of patients who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST Version 1.1., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first) as assessed by BICR per RECIST Version 1.1., TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST Version 1.1., Incidence of treatment-emergent AEs (TEAEs) and clinical laboratory abnormalities., Mean change from baseline in the physical functioning domain of the EORTC QLQ-C30 at Week 25, TTD of fatigue domain of the EORTC QLQ-C30 is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (ie, ≥

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Countries

Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain

Outcome results

None listed