Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAstraZeneca

About this trial

Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.

Eligibility criteria

Qualifiers

BC patients, male and female,

18 years old and older,

Pre or post menopausal,

With HR+ (ER and/or PR positive) and Her-2 negative (confirmed centrally),

Disqualifiers

Patients WITHOUT HR+ (ER- and/or PR-positive)/HER2-negative disease,

Patients without radiological and/or pathological confirmation of locally unresectable and/or metastatic breast cancer,

Patients who are NOT candidates for further systemic treatment following a diagnosis of metastatic disease or disease progression,

Patients who have already started a CDK4/6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) for first-line metastatic disease (for Cohort 1);

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

170 Participants
are grouped into 3 trial groups

Locations

6
Ensino E Terapia de Inovação Clínica Amo - Ética41.950-640, SalvadorEstado de Bahia, Brazil
Irmandade Da Santa Casa de Misericórdia de Porto Alegre90020-090, Porto AlegreRio Grande do Sul, Brazil
Fundação Antonio Prudente - A.C. Camargo Cancer Center01.509-900, São Paulo Brazil
Instituto D'Or de Pesquisa E Ensino - São Paulo01401-002, São Paulo Brazil

Sponsors and collaborators

AstraZeneca

Lead sponsor