NCT04588298

A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer

A Randomised, Open-Label, Parallel-Group, Pre-surgical Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2-negative Primary Breast Cancer (SERENA-3)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, open-label, parallel-group, pre-surgical study aimed to investigate the biological effects, safety, tolerability, and pharmacokinetics (PK) of different doses of oral AZD9833 in post-menopausal women with primary breast cancer

Detailed description

The study will be conducted in approximately 20 study centers across 3 countries and will be conducted in three stages (stage 1, stage 2 and stage 3). After the screening visit and confirmation of eligibility, evaluable participants will be enrolled across treatment groups. In stage 1, up to 24 evaluable participants across two treatment groups will be enrolled. A Safety and Data Monitoring Committee will convene to review stage 1 data and decide whether further treatment groups are required in stage 2. Stage 2 will include participants across up to 3 treatment groups. Stage 3 will include two treatment groups: Stage 1 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily Stage 2 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily Group 3: AZD9833 Dose C once daily Stage 3 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily Adverse events and concomitant medications information will be collected throughout the study. Thereafter there will be 28-day follow-up visit after discontinuation of study treatment

Conditions

• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	AZD9833	AZD9833 tablets will be administered orally.

Timeline

• Start date: 2020-11-02
• Primary completion: 2023-06-19
• Completion: 2023-06-19
• First posted: 2020-10-19
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

12 sites across 3 countries: Georgia, Mexico, United Kingdom