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Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

NCT05814224 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-04-14

No results posted yet for this study

Summary

The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.

Conditions

  • Hormone Receptor Positive Breast Carcinoma
  • Breast Neoplasms
  • Neoplasms, Breast
  • Breast Diseases
  • Antineoplastic Agents
  • Aromatase Inhibitors
  • ESR1 Gene Mutation

Interventions

DIAGNOSTIC_TEST

Liquid biopsy and CT scan

CT scan and liquid biopsy blood sample are performed at baseline, after 8 weeks from baseline and, then, every 12 weeks. Between two subsequent CT scan another liquid biopsy blood sample is performed. CEA and CA 15.3 will be performed at baseline and then concomitantly to the radiological evaluation

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    lead OTHER

Principal Investigators

  • Fabio Puglisi, MD · Centro di Riferimento Oncologico - Aviano

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814224 on ClinicalTrials.gov