CLEAR: Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer
Study Details
Study Description
Brief Summary
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endocrine and local treatments 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 |
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).
Other Names:
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gangnam Severance Hospital | Seoul | Korea, Republic of | 135720 |
Sponsors and Collaborators
- Gangnam Severance Hospital
- Severance Hospital
- Samsung Medical Center
- Asan Medical Center
Investigators
- Principal Investigator: Joon Jeong, Ph.D., Gangnam Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLEAR