NCT05963984

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Carrick Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Conditions

• Metastatic Breast Cancer
• Locally Advanced Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Samuraciclib	Samuraciclib tablet by mouth once a day
DRUG	Fulvestrant	Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-03-20
• Completion: 2025-08-28
• First posted: 2023-07-27
• Last updated: 2025-12-26

Locations

32 sites across 5 countries: United States, Hungary, Mexico, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study