Clinical Trials /

Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer

NCT03750396

Description:

Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

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

NameTypeDescriptionInterventions
Endocrine and local treatmentsExperimentalEndocrine 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) Palliative radiotherapy iv) 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