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Clinical Research & Trials

uso 21448

A Phase 2, Single-Arm, Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients with Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting (G1T28-213)


Disease Types: Breast Cancer Research

Eligibility Requirements:

Locally advanced or metastatic triple negative breast cancer with disease progression during or after 2 lines of systemic chemotherapy, PARP inhibitors (Olaparib, talazoparib) count as line of treatment if BRCA1 or BRCA2 positive, must have had prior taxane treatment unless contraindicated or not able to tolerate
-No: prior treatment with trilaciclib, sacitizumab-govitecan, irinotecan, Trop-2 antibody drug conjugate; known brain metastasis; bone-only disease; history of clinically significant gastrointestinal bleeding, intestinal obstruction, gastrointestinal perforation; hi-dose systemic corticosteroids within 2 weeks of first dose; current use of immunosuppressive medication (topical, inhaled, intranasal, & local injection allowed); uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (NYHA class III or IV); history of stroke or CVA within 6 months prior to first dose of study treatment; known active infection including  HIV, Hep B, Hep C, or tuberculosis; prior stem cell or bone marrow transplant

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