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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT03455270). This is a study registration, not published results. Lead sponsor: G1 Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 107 participants (ACTUAL). Conditions: Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Stage IV Breast Cancer. Interventions: DRUG: G1T48; DRUG: Palbociclib. Primary outcome measures: Dose Limiting Toxicity , Cycle 1 Day -3 to Cycle 1 Day 28; Recommended Phase 2 dose , 12 months; Number of Treatment Related Adverse Event, including Abnormal Laboratory Events , 21 months. Brief summary: This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All 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, 184 patients may be enrolled in the study.