SERENA-1b
Research type
Research Study
Full title
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)
IRAS ID
1013473
Contact name
Josh Simmonds
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
This is a study for women with advanced breast cancer that has progressed after previous treatments. The study aims to test a new combination of two experimental drugs (meaning they have not been approved by health authorities except in research studies like this one), camizestrant and atirmociclib. Each study drug has been shown to be safe when taken alone and when taken with similar types of drugs. This study tests whether camizestrant together with atirmociclib is also safe and whether this combination may slow or stop cancer growth. Researchers will carefully monitor participants to understand how the drugs work together and their potential benefits for patients with oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
Approximately 24 participants will be enrolled for this study globally and all participants will receive the study drugs camizestrant and atirmociclib.
The study drugs will be given in 28 day cycles. Participants will take standard doses of camizestrant (one 75 mg tablet once daily in a 28-day cycle) and atirmociclib (three 100 mg tablets twice daily in a 28-day cycle [600 mg in total each day]).
Participants will continue to receive the study treatment until their cancer progresses, they experience unacceptable side effects, they choose to withdraw from the study, or the study doctor determines it is no longer in their best interest to continue.
The study involves taking the oral study drugs at home, with regular study visits to monitor health and treatment response. During the study, participants will have specific blood tests and assessments (such as physical examinations, scans and heart tests) at the study hospital, some of these will be in addition or more frequent than standard care.
This study is organised and funded by AstraZeneca (AZ).REC name
North East - York Research Ethics Committee
REC reference
26/NE/0027
Date of REC Opinion
10 Mar 2026
REC opinion
Further Information Favourable Opinion