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

  • STATUS
    Recruiting
  • End date
    Jul 16, 2024
  • participants needed
    45
  • sponsor
    G1 Therapeutics, Inc.
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Updated on 16 May 2022
See if I qualify
metastasis
HER2
triple negative breast cancer
erbb2
BRCA1
BRCA2
taxane
mammogram

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.

Description

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of the first dose of study treatment and completes at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy will be administered intravenously (IV) in 21-day cycles. Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first. The first Survival Follow-up assessment should occur approximately 3 months after the Safety Follow-Up Visit and will continue every 3 months until the end of the study (or death).

Details
Condition Triple Negative Breast Cancer
Treatment Trilaciclib, Sacituzumab Govitecan-hziy
Clinical Study IdentifierNCT05113966
SponsorG1 Therapeutics, Inc.
Last Modified on16 May 2022

Eligibility

 Yes No Not Sure

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 UGT1A128 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
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