Phase 2
Completed N=135
A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
Source: ClinicalTrials.gov NCT04588298 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Percentage Change From Baseline in Estrogen Receptor (ER) Expression Between Pre- and On-treatment Tumour Samples (Primary Analysis) — -62.7; -62.8; -67.1; -66.9 Percentage change from baseline
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Estrogen Receptor (ER) Expression Between Pre- and On-treatment Tumour Samples (Primary Analysis) |
-62.7; -62.8; -67.1; -66.9; -65.0 | — |
| PRIMARY Percentage Change From Baseline in ER Expression Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis) |
-62.1; -62.3; -66.6; -66.9; -65.0 | — |
| SECONDARY Percentage Change From Baseline in Progesterone Receptor (PgR) Expression Between Pre- and On-treatment Tumour Samples (Primary Analysis) |
194.8; -3.0; 170.3; -24.2; 463.8 | — |
| SECONDARY Percentage Change From Baseline in PgR Expression Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis) |
-35.2; -44.0; -36.7; -61.8; -55.0 | — |
| SECONDARY Percentage Change From Baseline in Ki-67 Labelling Index Between Pre- and On-treatment Tumour Samples (Primary Analysis) |
-40.3; -79.4; -78.2; -73.0; -77.5 | — |
| SECONDARY Percentage Change From Baseline in Ki-67 Labelling Index Between Pre- and On-treatment Tumour Samples (Sensitivity Analysis) |
-49.3; -81.3; -78.9; -81.7; -81.9 | — |
| SECONDARY Number of Patients With Adverse Events (AEs) |
9; 17; 9; 11; 19; 4 | — |
| SECONDARY Plasma Concentrations of AZD9833 |
50.712; 122.134; 180.773; 46.939; 120.516; 58.304 | — |
Eligibility Criteria
Inclusion criteria
- Provision of written informed consent prior to study entry
- Female participants aged at least 18 years
- Post-menopausal status defined as meeting at least one of the following criteria:
- Have undergone a bilateral oophorectomy
- Age ≥ 60 years
- Age ≥ 50 and 470 msec; resting heart rate of < 50 bpm for stages 1 and 2 at screening;resting heart rate <60 bpm at screening for Stage 3; any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; any factors that increase the risk of QTc prolongation or risk of arrhythmic events; known left ventricular ejection fraction < 50%; significant cardiovascular procedure or event within the last 6 months; uncontrolled hypertension or symptomatic hypotension
- Inadequate bone marrow reserve or organ function
- Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833
- History of hypersensitivity to active or inactive excipients of AZD9833
- Previous randomisation in the present study
- Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements
Data sourced from ClinicalTrials.gov (NCT04588298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.