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

Breast Cancer Clinical Trial

— CLEAR  

Official title:

Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750396
• Other study ID #: CLEAR
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

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

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