A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Summary
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Timeline
- Start
- 2021-01-28
- Primary completion
- 2026-06-26
- Completion
- 2029-02-01
Outcome
Missed primary endpoint
release “SERENA-4 trial did not meet primary objective of statistically significant improvement in progression-free survival, however a numerical improvement was observed” astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Camizestrant | Other / unclassified | 75 mg | Oral |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |
| Background | Leuprolide | Other / unclassified | — | Subcutaneous |
| Background | Palbociclib | Small molecule | 125 mg | Oral |