Study of AZD9833 Alone or in Combination in Women with Advanced Breast Cancer. - SERENA-1

Study identifier:D8530C00001

ClinicalTrials.gov identifier:NCT03616587

EudraCT identifier:2018-000667-92

CTIS identifier:N/A

Recruitment Complete

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)

Medical condition

ER+ HER2- Advanced Breast Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus, AZD9833 with abemaciclib, AZD9833 with capivasertib, AZD9833 with ribociclib, AZD9833 with anastrozole

Sex

Female

Actual Enrollment

396

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 11 Oct 2018
Estimated Primary Completion Date: 16 Sept 2024
Estimated Study Completion Date: 16 Sept 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria