NCT03616587

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a multicentre dose escalation and expansion, first-in-human study designed to evaluate the safety and tolerability of AZD9833, alone (Parts A and B), or in combination with palbociclib (Parts C and D), or in combination with everolimus (Parts E and F), or in combination with abemaciclib (± anastrozole) (Parts G and H), or in combination with capivasertib (Parts I and J), or in combination with ribociclib (± anastrozole) (Parts K and L), or in combination with anastrozole (Parts M and N) in women with endocrine-resistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent.

Conditions

• ER+ HER2- Advanced Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-11
• Primary completion: 2024-09-16
• Completion: 2027-06-24
• First posted: 2018-08-06
• Last updated: 2026-01-28

Locations

17 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study