Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
- Adult ( ≥18 years of age), fFemale or male patient with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC
- Documentation of histologically or cytologically confirmed ER-negative, PR-negative, and HER2-negative tumor per the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (ASCO/CAP) criteria.
- Patient must have had documented disease progression during or after 2 lines of
systemic chemotherapy treatment for unresectable, locally advanced or metastatic
breast cancer (these regimens will qualify regardless of TNBC status at the time they
- One prior line of chemotherapy treatment could be in the neoadjuvant or adjuvant setting if progression occurred within 12 months of completion of chemotherapy;
- Patients must have prior taxane treatment in either the neoadjuvant, adjuvant, or advanced/metastatic setting OR patients must have demonstrated contraindications or are intolerant to taxanes;
- PARP inhibitors may meet the criteria for one of two lines of therapy if patient has documented germline BRCA1/BRCA2 mutation.
- ECOG performance status of 0 or 1.
- Adequate organ function as demonstrated by the following laboratory values:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1.5 × 109/L;
- Platelet count ≥100 × 109/L;
- Estimated glomerular filtration rate ≥30 mL/minute/1.73 m2;
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
- ALT and AST ≤3 × ULN in the absence of liver metastasis or ≤5 × ULN in the presence of liver metastasis.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload.
- Patients with known brain metastasis at enrollment.
- Patients with known Gilbert's disease or known homozygous for the UGT1A1*28 allele.
- Patients with bone-only disease.
- Malignancies other than TNBC within 3 years prior to enrollment.
- History of clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of enrollment.
- Receipt of any high dose systemic corticosteroids within 2 weeks prior to the first dose of study treatment.
- Current use of immunosuppressive medication.
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association functional classification system).
- History of stroke or cerebrovascular accident within 6 months prior to first dose of study treatment.
- Serious active infection or severe infection within 4 weeks prior to enrollment.
- Prior hematopoietic stem cell or bone marrow transplantation.
- Pregnant or lactating women
Join this Trial
- TRIO-US - Bakersfield
- TRIO-US - Hollywood FL
- TRIO-US - Las Vegas
- TRIO-US - Orlando FL
- UCLA Burbank
- UCLA Laguna Hills
- UCLA Parkside
- UCLA San Luis Obispo
- UCLA Santa Monica
- UCLA Westlake Village