NCT07701070Not yet recruiting
SHIELD: Surveillance of HR+/HER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC
A Multicenter Study to Describe the Frequency and Emergence of ESR1 Mutations in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer Receiving First-Line Endocrine Based Therapy
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Mar 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07701070
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 30 Sept 2026 to the primary completion date, 30 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of disease progression during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy, based on investigator assessment.
Other
- Known ESR1 mutation status at study entry.
Who the study is looking for
- Age 18 years or older at the time of informed consent and willing and able to provide informed consent before any study-related procedures.
- Histologically- or cytologically-confirmed hormone receptor-positive (ER- and/or progesterone receptor-positive), human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer.
- Receiving first-line therapy with an aromatase inhibitor in combination with a CDK4/6 inhibitor for at least 6 months and no more than 18 months, with no evidence of disease progression at study entry, as assessed by the investigator.
- Able and willing to provide a blood sample for circulating tumour DNA testing for ESR1 mutation assessment at approximately quarterly intervals.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.