Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYeon Hee Park

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sacituzumab Govitecan with pegfilgrastim

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yeon Hee Park

Lead sponsor

Samsung Medical Center

Sponsor institution