Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens
Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
Patients aged ≥19 years at the time of signing ICF.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of ≥ 12 weeks.
Prior treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
Received any prior treatment with a Trop-2-directed ADC.
Patients with carcinomatous meningitis.
Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
Single group
Sacituzumab Govitecan with pegfilgrastim
Drug▪ Sacituzumab Govitecan group \- Sacituzumab Govitecan 10mg/kg IV on CnD1 and D8 + Pegfilgrastim 6mg SC QD on CnD9
To evaluate the incidence of grade ≥3 neutropenia
Incidence of grade ≥3 neutropenia after 2 cycles of treatment
Safety and tolerability of the study regimen
Incidence of AEs
Objective Response Rate
The percentage of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1
Progression Free Survival
Overall Survival
The time until defined by date of all-cause mortality from the date of 1st infusion The time until defined by date of all-cause mortality from the date of 1st infusion
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Yeon Hee Park
Lead sponsor
Samsung Medical Center
Sponsor institution
