NCT07427394

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Detailed description

This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib. The single-arm study includes: * Screening period * Atirmociclib single dose period * Doublet intervention period * Post-treatment follow-up period

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Camizestrant	Camizestrant will be administered orally.
DRUG	Atirmociclib	Atirmociclib will be administered orally.

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-12-03
• Completion: 2027-12-03
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

6 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study