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
This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants 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), female or male participant 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.
• Measurable disease as defined by RECIST v1.1.
• Considered to be eligible to receive sacituzumab govitecan-hziy treatment, in the Investigator's judgment.
• Participants must have received 2 or more prior lines of systemic therapy, at least one of them in the metastatic setting.
• Radiation therapy for metastatic disease is permitted as long as the participant has at least 1 measurable lesion that has not been irradiated. Participants should be sufficiently recovered from the effects of radiation as determined by the Investigator but must have completed radiotherapy at least 2 weeks prior to enrollment.
• 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 × 10\^9/L;
⁃ Platelet count ≥100 × 10\^9/L;
⁃ Estimated glomerular filtration rate ≥30 mL/minute/1.73 m\^2;
⁃ 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.
• Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1 (except alopecia or peripheral neuropathy that may be Grade 2 or less).
⁃ Predicted life expectancy of ≥3 months.
⁃ Contraceptive use by men or women should be consistent with local guidelines regarding the methods of contraception for those participating in clinical studies.
⁃ Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.