Clinical trial · Interventional
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
NCT03750396CI-TRIAL-00037076CLEARunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen Receptor Positive Tumor | — | UNRESOLVED | — |
| Her2-negative Tumor | — | UNRESOLVED | — |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endocrine and local treatments
- description
- 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
- interventionNames
- Procedure: Surgical resection
- Radiation: Stereotactic body radiotherapy
- Procedure: Radiofrequency ablation
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.