OncoMatch/Clinical Trials/NCT06120283
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Is NCT06120283 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for advanced solid tumor.
Treatment: BGB-43395 · Fulvestrant · Letrozole · Elacestrant · Anti-Diarrheal Agent — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Tumor Agnostic
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression
HR+ breast cancer
Required: HER2 (ERBB2) wild-type
HER2-negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — advanced/metastatic disease or adjuvant
must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting
Must have received: CDK4/6 inhibitor — advanced/metastatic disease or adjuvant
must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting
Cannot have received: CDK4/6 inhibitor
must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease
Cannot have received: systemic therapy for advanced disease
must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation, or organ transplantation
Cannot have received: organ transplantation
Prior allogeneic stem cell transplantation, or organ transplantation
Lab requirements
Blood counts
Adequate organ function without symptomatic visceral disease
Kidney function
Adequate organ function without symptomatic visceral disease
Liver function
Adequate organ function without symptomatic visceral disease
Adequate organ function without symptomatic visceral disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute (Scri) At Health One · Denver, Colorado
- Florida Cancer Specialists and Research Institute · Lake Mary, Florida
- Karmanos Cancer Institute · Detroit, Michigan
- Washington University School of Medicine · St Louis, Missouri
- Duke Cancer Center · Durham, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06120283 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, systemic therapy for advanced disease, allogeneic stem cell transplantation disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages