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Elacestrant / Advanced Breast Cancer / Metastatic Breast Cancer · Phase 1 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 1 dose-escalation and dose-expansion trial of BGB-43395, a CDK4 inhibitor, as monotherapy or combined with endocrine therapies in HR+ HER2− breast cancer and other solid tumors. The study is currently recruiting and has not yet reported results; primary endpoints are safety, adverse events, and identification of the recommended dose for expansion.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Ho…; age from 18 Years. Intervention: Dose Escalation; Safety Expansion; Dose Expansion Cohort 1; Dose Expansion Cohort 2; Dose Expansion Cohort 3. n = 399. 62 sites across 11 countries.
This is a registered Phase 1 dose-escalation and dose-expansion trial of BGB-43395, a CDK4 inhibitor, as monotherapy or combined with endocrine therapies in HR+ HER2− breast cancer and other solid tumors. The study is currently recruiting and has not yet reported results; primary endpoints are safety, adverse events, and identification of the recommended dose for expansion.
Phase 1 studies are designed for safety and dosing, not clinical benefit assessment.
The source did not state who this applies to in practice.
This is a Phase 1 dose-escalation and dose-expansion trial registration with no results posted; it is a first-in-human safety and tolerability study designed to establish dosing, not efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06120283). This is a study registration, not published results. Lead sponsor: BeOne Medicines. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 399 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast, HER2-negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Non-small Cell Lung Cancer. Interventions: DRUG: BGB-43395; DRUG: Fulvestrant; DRUG: Letrozole; DRUG: Elacestrant; DRUG: Anti-Diarrheal Agent. Primary outcome measures: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) , Up to approximately 60 months; Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 , Up to approximately 60 months; Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 , Up to approximately 60 months; Phase 1b: Objective Response Rate (ORR) , Up to approximately 60 months. Brief summary: This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
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