Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 7:55 PM
Study NCT ID:
NCT04541433
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2020-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti- Tumor Activity of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. This study consists of 2 cohorts, Cohort1 and Cohort2. In cohort 1 (for tolerability evaluation), a minimum of 3, or up to 6, evaluable Japanese patients with ER+ HER2- breast cancer will be enrolled. In cohort 2 (for exploratory research), at least 6 to maximum 12 evaluable Japanese patients with ER+ HER2- breast cancer will be enrolled.
Detailed Description:
Objectives:
Primary objective:
To investigate the safety and tolerability of AZD9833 in Japanese women with ER+ HER2- advanced breast cancer
Secondary objective:
To assess the anti-tumor activity and efficacy of AZD9833
Exploratory objectives:
To investigate AZD9833 activity in tumor cells
Overall design:
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. Eligible patients will receive AZD9833. In cohort 1 (for tolerability evaluation), a minimum of 3 to maximum 6 evaluable patients will be enrolled.
For cohort 2, if paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
In cohort 2 (for exploratory research), eligible patients will receive AZD9833 once daily and at least 6 to maximum 12 patients will be enrolled. In cohort 2, paired biopsy sample will be collected from at least 6 and maximum 12 patients. If paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
Number of Subjects:
Maximum 18 evaluable subjects will be enrolled in this study.
Primary objective:
To investigate the safety and tolerability of AZD9833 in Japanese women with ER+ HER2- advanced breast cancer
Secondary objective:
To assess the anti-tumor activity and efficacy of AZD9833
Exploratory objectives:
To investigate AZD9833 activity in tumor cells
Overall design:
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. Eligible patients will receive AZD9833. In cohort 1 (for tolerability evaluation), a minimum of 3 to maximum 6 evaluable patients will be enrolled.
For cohort 2, if paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
In cohort 2 (for exploratory research), eligible patients will receive AZD9833 once daily and at least 6 to maximum 12 patients will be enrolled. In cohort 2, paired biopsy sample will be collected from at least 6 and maximum 12 patients. If paired biopsy after administration of the study drug becomes inoperable during administration of the study drug, additional subjects can be added to obtain an evaluable biopsy sample.
Number of Subjects:
Maximum 18 evaluable subjects will be enrolled in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: