Actively Recruiting
Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer.
Led by AstraZeneca · Updated on 2026-03-19
70
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Observational study on prevalence of emerging ESR1 mutations in liquid biopsy in two cohorts of patients with breast cancer (with and without prior therapies in metastatic setting) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.
CONDITIONS
Official Title
Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer patients, male or female, aged 18 years or older, pre or post menopausal, with hormone receptor-positive (ER and/or PR positive), Her-2 negative locally advanced irresectable and/or metastatic disease confirmed centrally
- Confirmation of hormone receptor and Her-2 status by testing primary tumor or metastatic lesion (discordant results allowed)
- Candidates for CDK4/6 inhibitor therapy combined with endocrine therapy in the first line setting, with or without ovarian suppression
- May have received one prior chemotherapy line in metastatic setting but no endocrine therapy in metastatic setting
- May have received chemotherapy and/or endocrine therapy in neo/adjuvant settings
- May have received CDK4/6 inhibitor in adjuvant setting if still eligible for CDK4/6 inhibitor in metastatic setting
- Able to undergo liquid biopsy before starting first line treatment
- All patients must provide signed informed consent
- For Cohort 2: patients who progressed on CDK4/6 inhibitor combined with endocrine therapy in first or second line setting, meeting all other non-conflicting criteria for Cohort 1
You will not qualify if you...
- Patients with hormone receptor-positive and Her-2 negative disease not confirmed centrally
- Patients without radiologic or pathologic confirmation of locally irresectable and/or metastatic breast cancer
- Patients not candidates for further systemic treatment after metastatic diagnosis or progression
- Patients who have already started CDK4/6 inhibitor combined with endocrine therapy for metastatic disease in first line setting (Cohort 1)
- Patients who have started new treatment after progression on CDK4/6 inhibitor combined with endocrine therapy (Cohort 2)
- Patients unable to undergo liquid biopsy procedure
- Patients unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
São Paulo, Brazil, 04513-020
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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