A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer (SERENA-3)
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- STATUS
- Recruiting
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- days left to enroll
- 39
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- participants needed
- 92
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- sponsor
- AstraZeneca
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.
Description
The study will be conducted in approximately 20 study centers across 3 countries and will be conducted in two stages (stage 1 and stage 2). 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 may include participants across up to 3 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
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
Details
| Condition | HER2-negative Breast Cancer |
|---|---|
| Treatment | fulvestrant, AZD9833 |
| Clinical Study Identifier | NCT04588298 |
| Sponsor | AstraZeneca |
| Last Modified on | 4 October 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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