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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03750396
Other study ID # CLEAR
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2018
Est. completion date July 31, 2025

Study information

Verified date February 2019
Source Gangnam Severance Hospital
Contact Sung Gwe Ahn, Ph.D.
Phone 82-2-2019-4402
Email asg2004@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date July 31, 2025
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (4)

Lead Sponsor Collaborator
Gangnam Severance Hospital Asan Medical Center, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival Failure: progression or death due to any cause 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 Overall survival Failure: death due to any cause From the date of registration to the date of death or last follow-up; assessed up to 10 years
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