Clinical Trial: NCT03616587
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-18 |
Study Overview
Brief Summary
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
Official Title
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1)
Conditions
ER+ HER2- Advanced Breast Cancer
Intervention / Treatment
- Drug: AZD9833
- Drug: AZD9833
- Drug: AZD9833 with palbociclib
- Drug: AZD9833 with palbociclib
- Drug: AZD9833 with everolimus
- Drug: AZD9833 with everolimus
- Drug: AZD9833 with abemaciclib
- Drug: AZD9833 with abemaciclib
- Drug: AZD9833 with capivasertib
- Drug: AZD9833 with capivasertib
- Drug: AZD9833 with ribociclib
- Drug: AZD9833 with ribociclib
- Drug: AZD9833 with anastrozole
- Drug: AZD9833 with anastrozole
Other Study ID Numbers
- D8530C00001
- 138396
- 2023-506890-37-00
- 2018-000667-92
- 2018
- 2023
Start Date (Actual)
2018-10-11
Primary Completion Date (Actual)
2024-09-16
Study Completion Date (Estimated)
2027-06-24
Enrollment (Actual)
396
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-18 |
Study Overview
Brief Summary
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
Official Title
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1)
Conditions
ER+ HER2- Advanced Breast Cancer
Intervention / Treatment
- Drug: AZD9833
- Drug: AZD9833
- Drug: AZD9833 with palbociclib
- Drug: AZD9833 with palbociclib
- Drug: AZD9833 with everolimus
- Drug: AZD9833 with everolimus
- Drug: AZD9833 with abemaciclib
- Drug: AZD9833 with abemaciclib
- Drug: AZD9833 with capivasertib
- Drug: AZD9833 with capivasertib
- Drug: AZD9833 with ribociclib
- Drug: AZD9833 with ribociclib
- Drug: AZD9833 with anastrozole
- Drug: AZD9833 with anastrozole
Other Study ID Numbers
- D8530C00001
- 138396
- 2023-506890-37-00
- 2018-000667-92
- 2018
- 2023
Start Date (Actual)
2018-10-11
Primary Completion Date (Actual)
2024-09-16
Study Completion Date (Estimated)
2027-06-24
Enrollment (Actual)
396
Study Type
Interventional
Phase
Phase 1