Breast Cancer Clinical Trial
— CLEAROfficial 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
NCT number | NCT03750396 |
Other study ID # | CLEAR |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | July 31, 2025 |
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gangnam Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital | Asan Medical Center, Samsung Medical Center, Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Failure: progression or death due to any cause | 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 | |
Secondary | Overall survival | Failure: death due to any cause | From the date of registration to the date of death or last follow-up; assessed up to 10 years |
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