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About
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.
Enrollment
Sex
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Inclusion criteria
Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin
Patients must satisfy 1 of the following criteria for prior therapy:
For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
For Part 2, measurable disease as defined by RECIST, Version 1.1
ECOG performance status 0 to 1
Adequate organ function
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
102 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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