Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
NCT03616587 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 396
Last updated 2026-04-30
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)
Conditions
- ER+ HER2- Advanced Breast Cancer
Interventions
- DRUG
-
AZD9833
Part A: AZD9833 monotherapy dose escalation.
- DRUG
-
AZD9833
Part B: AZD9833 monotherapy expansion.
- DRUG
-
AZD9833 with palbociclib
Part C: AZD9833 in combination with palbociclib dose escalation
- DRUG
-
AZD9833 with palbociclib
Part D: AZD9833 in combination with palbociclib expansion
- DRUG
-
AZD9833 with everolimus
Part E: AZD9833 in combination with everolimus dose escalation
- DRUG
-
AZD9833 with everolimus
Part F: AZD9833 in combination with everolimus dose expansion
- DRUG
-
AZD9833 with abemaciclib
Part G: AZD9833 in combination with abemaciclib (± anastrozole) dose escalation
- DRUG
-
AZD9833 with abemaciclib
Part H: AZD9833 in combination with abemaciclib (± anastrozole) dose expansion
- DRUG
-
AZD9833 with capivasertib
Part I: AZD9833 in combination with capivasertib dose escalation
- DRUG
-
AZD9833 with capivasertib
Part J: AZD9833 in combination with capivasertib dose expansion
- DRUG
-
AZD9833 with ribociclib
Part K: AZD9833 in combination with ribociclib (± anastrozole) dose escalation
- DRUG
-
AZD9833 with ribociclib
Part L: AZD9833 in combination with ribociclib (± anastrozole) dose expansion
- DRUG
-
AZD9833 with anastrozole
Part M: AZD9833 in combination with anastrozole dose escalation
- DRUG
-
AZD9833 with anastrozole
Part N: AZD9833 in combination with anastrozole dose expansion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Richard Baird, MD PhD FRCP · Breast Cancer Research Unit, University of Cambridge
-
Justin Lindemann, MBChB MBA · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-11
- Primary Completion
- 2024-09-16
- Completion
- 2027-06-24
- FDA Drug
- Yes
Countries
- United States
- Spain
- United Kingdom
Study Locations
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