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Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer

NCT03750396 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-02-15

No results posted yet for this study

Summary

Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

Conditions

  • Breast Cancer
  • Recurrent Breast Cancer
  • Stereotactic Body Radiotherapy
  • Estrogen Receptor Positive Tumor
  • Her2-negative Tumor
  • Surgery

Interventions

PROCEDURE

Surgical resection

Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.

RADIATION

Stereotactic body radiotherapy

Deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Total radiation dose and fractions are various according to metastatic lesions (57\~97.5Gy/6\~10 Fraction).

PROCEDURE

Radiofrequency ablation

RFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃. The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating. This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis.

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Joon Jeong, Ph.D. · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-07-31
Completion
2025-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03750396 on ClinicalTrials.gov