SERENA-8
Research type
Research Study
Full title
SERENA-8: A Randomised, Multicentre, Open-label, Phase III Study of Camizestrant + Capivasertib Versus Fulvestrant + Capivasertib in Patients with Estrogen Receptor-positive, HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer With one or More PIK3CA/AKT1/PTEN Alterations Whose Disease has Progressed on Treatment With an Aromatase Inhibitor + CDK4/6 Inhibitor
IRAS ID
1010202
Contact name
Sam Ringle
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-510859-35
Research summary
The purpose of this study is to demonstrate the superiority of camizestrant + capivasertib as compared to fulvestrant + capivasertib in participants with ER+/HER2- ABC with one or more PIK3CA/AKT1/PTEN alterations whose disease has progressed on treatment with AI + CDK4/6i.
Participants will be randomised in a 1:1 ratio to either Arm 1 (Camizestrant + capivasertib) or Arm B (Fulvestrant + capivasertib). Study intervention will be continued until disease progression per Blinded Independent Central Review assessment, unless there is evidence of unacceptable toxicity, or if the participant requests to stop the study treatment.The total study size will be approximately 554 randomised. The study duration is estimated to be approximately 76 months from first participant randomised.
The visit frequency for study assessments during the study treatment phase will be 3 times during the first 28-days cycle, once every cycle from cycle 2 and beyond. Additional visits can occur per investigator’s discretion and local SoC.
After study intervention discontinuation, all participants will undergo an EoT visit. They will be followed up for safety assessments at least 30 days after their last dose at the safety follow-up visit and will be followed up in relation to survival status every 12 weeks from the date of the safety follow-up visit.
Participants who have discontinued study intervention in the absence of RECIST v1.1 defined radiological progression criteria confirmed by BICR, will be followed up with tumour assessments according to the SoA until RECIST v1.1-defined PD confirmed by BICR or death regardless of whether or not the participant started a subsequent anticancer therapy, unless they have withdrawn all consent to study related assessments.
All participants will be followed up for survival status and PFS2 after their last dose of treatment every 12 weeks from the safety follow-up visit until death, withdrawal of consent, or the end of the study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0135
Date of REC Opinion
5 Aug 2025
REC opinion
Further Information Favourable Opinion