NCT03750396

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-07-31
• Completion: 2025-07-31
• First posted: 2018-11-23
• Last updated: 2019-02-15

Locations

1 site across 1 country: South Korea