Status:

UNKNOWN

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

Lead Sponsor:

Gangnam Severance Hospital

Collaborating Sponsors:

Severance Hospital

Samsung Medical Center

Conditions:

Breast Cancer

Recurrent Breast Cancer

Eligibility:

FEMALE

20-75 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality. ...

Eligibility Criteria

Inclusion

  • ER-positive/HER2-negative in primary tumor
  • Oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant LNs)
  • Recurrent cancer after completion of primary treatment (RFI≥1year)
  • Metastatic lesions are feasible for resection or radiotherapy (Size≤3cm)

Exclusion

  • De Novo metastatic cancer at initial diganosis
  • Recurrence-free inverval \< 1 year

Key Trial Info

Start Date :

August 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2025

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT03750396

Start Date

August 1 2018

End Date

July 31 2025

Last Update

February 15 2019

Active Locations (1)

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1

Gangnam Severance Hospital

Seoul, South Korea, 135720