Local treatment for ER-positive/HER2-negative breast cancer with few metastases
Local Treatment in Addition to Endocrine Therapy in ER-positive/HER2-negative Oligo-metastatic Breast Cancer (CLEAR): a Multicentre, Single -Arm, Phase 2 Trial
This study is testing if combining local treatments like surgery and targeted radiation with hormone therapy can help people with a specific type of breast cancer that has spread a little but is still manageable.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03750396 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of local treatments, such as surgical resection and stereotactic body radiotherapy, combined with endocrine therapy for patients with oligometastatic ER-positive/HER2-negative breast cancer. The study aims to provide a first-line treatment option for patients with limited metastatic lesions, focusing on those with a recurrence-free interval of at least one year. The interventions are designed to target metastatic lesions that are manageable in size and number, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with ER-positive/HER2-negative breast cancer who have up to two metastatic lesions and a recurrence-free interval of at least one year.
Not a fit: Patients with de novo metastatic cancer or those who have had a recurrence-free interval of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and prolong survival for patients with oligometastatic breast cancer.
How similar studies have performed: Other studies have shown promise in using local treatments for oligometastatic breast cancer, indicating that this approach is supported by emerging evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Joon Jeong, Ph.D. — Gangnam Severance Hospital
- Study coordinator: Sung Gwe Ahn, Ph.D.
- Email: asg2004@yuhs.ac
- Phone: 82-2-2019-4402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.