Description:
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
Clinical Trials /
Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer
NCT03750396
Related Conditions:
- Breast Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer
- Official Title: Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial
Clinical Trial IDs
- ORG STUDY ID: CLEAR
- NCT ID: NCT03750396
Conditions
- Breast Cancer
- Recurrent Breast Cancer
- Stereotactic Body Radiotherapy
- Estrogen Receptor Positive Tumor
- Her2-negative Tumor
- Surgery
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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 |
Eligibility 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
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression-free survival |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Failure: progression or death due to any cause |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | From the date of registration to the date of death or last follow-up; assessed up to 10 years |
| Safety Issue: | |
| Description: | Failure: death due to any cause |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Gangnam Severance Hospital |
Trial Keywords
- Oligometastasis
- Local treatments
Last Updated
February 15, 2019
