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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocrine and local treatments | Experimental | Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer. Endocrine options included aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, fulvestrant, fulvestrant with CDK4/6 inhibitors, everolimus with exemestane, tamoxifen. For premenopausal women, agents for ovarian function suppression using GnRH agonists or surgical ovarian ablation including bilateral salpingo-oophorectomy are allowed. Local treatments for metastatic lesions will be added in this group. Local treatments include modalities described below: i) Surgical resection: the achievement of tumor-free margin is not obligatory. ii) Stereotactic body radiotherapy iii) Radiofrequency ablation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical resection | Procedure | Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
-ER-positive/HER2-negative in primary tumor
Exclusion Criteria:
Biologically woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Joon Jeong, Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | 135720 | South Korea |
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Endocrine therapy is a standard-of-care for 1st line treatment in the patients with ER+/HER2- metastatic breast cancer.
Local treatments for metastatic lesions will be added in this group.
All patients will undergo local treatments in addition to endocrine therapies.
Local treatments include modalities described below:
i) Surgical resection: the achievement of tumor-free margin is not obligatory.
ii) Stereotactic body radiotherapy
iii) Radiofrequency ablation
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| Stereotactic body radiotherapy | Radiation | 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). |
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| Radiofrequency ablation | Procedure | 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. |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |
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