SHIELD: Surveillance of HR+/HER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC

Sponsor
AstraZeneca
Study ID
NCT07701070
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood sampling — OTHER
    Blood sampling for ctDNA-based ESR1 mutation testing, which are associated with minimal additional risk and burden compared with routine clinical practice

Study Details

This is a multicountry, multicenter, observational study in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer receiving first-line endocrine-based therapy with an aromatase inhibitor in combination with a CDK4/6 inhibitor. The study aims to describe the prevalence of ESR1 mutations at baseline and the emergence of ESR1 mutations over time using circulating tumor DNA testing in routine clinical practice. Patients receiving first-line treatment for at least 6 months and no more than 18 months, without evidence of disease progression at study entry, may undergo baseline ESR1 mutation testing. Patients with a negative baseline result may undergo longitudinal monitoring approximately every 3 months, for up to 18 months or 6 testing timepoints, to assess emergence of ESR1 mutations. The study will also describe mutation subtypes, testing methods used in routine practice, selected clinical characteristics, and treatment patterns across participating countries.

Key Dates

First listed
Jul 14, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Mar 30, 2029
Completion
Mar 30, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Participants with HR-positive, HER2-negative advanced breast cancer
    Adults with HR-positive, HER2-negative advanced breast cancer receiving first-line therapy with an aromatase inhibitor plus a CDK4/6 inhibitor for 6 to 18 months without disease progression at study entry. Participants undergo baseline ESR1 mutation testing using circulating tumour DNA; those with a negative baseline result may undergo follow-up testing approximately every 3 months for up to 18 months.

Primary Outcome Measure

Prevalence of ESR1 mutations in circulating tumour DNA [ Time Frame: At baseline, approximately 3, 6, 9, 12, 15, and 18 months after initial testing ]

Central Contacts

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