Open Actively Recruiting

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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 were administered):
    • 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.

Exclusion Criteria:

  • 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

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Study Stats
Protocol No.
21-002028
Category
Hematology-Oncology
Oncology
Contact
Monica Rocha
Location
  • 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
For Providers
NCT No.
NCT05113966
For detailed technical eligibility, visit ClinicalTrials.gov.