Breast Cancer, Estrogen Receptor Positive Tumor, Her2-negative Tumor, Recurrent Breast Cancer, Stereotactic Body Radiotherapy, Surgery
Conditions
Keywords
Oligometastasis, Local treatments
Brief 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.
Interventions
PROCEDURESurgical resection
Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.
RADIATIONStereotactic 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).
PROCEDURERadiofrequency 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.
Sponsors
Severance Hospital
Samsung Medical Center
Asan Medical Center
Gangnam Severance Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 | Failure: progression or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the date of registration to the date of death or last follow-up; assessed up to 10 years | Failure: death due to any cause |
Countries
South Korea
Contacts
Primary ContactSung Gwe Ahn, Ph.D.
Backup ContactJoon Jeong, Ph.D.
Outcome results
None listed