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

Gangnam Severance Hospital110 enrolled

Overview

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

Local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. Stereotactic body radiotherapy is preferred as a radiation modality. Endocrine therapies with/without target therapy including CDK4/6 inhibitors or mTOR inhibitors are the mainstay of 1st line treatment for ER-positive/HER2-negative metastatic breast cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

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

Interventions

Surgical resectionPROCEDURE

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

Stereotactic body radiotherapyRADIATION

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).

Radiofrequency ablationPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: -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 Criteria: * De Novo metastatic cancer at initial diganosis * Recurrence-free inverval \< 1 year

Locations (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival

Failure: progression or death due to any cause

Time frame: From the date of registration to the date of first PFS failure or last follow-up; assessed up to 6 years; Median PFS of all registered patients will be over 30 months

Secondary Outcomes

Overall survival

Failure: death due to any cause

Time frame: From the date of registration to the date of death or last follow-up; assessed up to 10 years

Central Contacts

Sung Gwe Ahn, Ph.D.

CONTACT

82-2-2019-4402 asg2004@yuhs.ac

Joon Jeong, Ph.D.

CONTACT

82-2-2019-3379 gsjjoon@yuhs.ac

Data from ClinicalTrials.gov

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