Radiation therapy tailored to tumor biology for advanced breast cancer
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
This study is testing if adjusting radiation therapy based on how well tumors respond to earlier chemotherapy can help people with advanced breast cancer live longer and feel better after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05896865 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of postoperative radiation therapy in patients with Stage III breast cancer who have metastasis to internal mammary or supraclavicular lymph nodes. It aims to adapt the total radiation dose based on the tumor's response to prior neoadjuvant chemotherapy. Key outcomes include 5-year disease-free survival, overall survival, locoregional recurrence rates, adverse events, and quality of life assessments using validated questionnaires. Participants will undergo thorough evaluations before and after treatment to assess their disease status and quality of life.
Who should consider this trial
Good fit: Ideal candidates are females aged 19 or older with Stage III breast cancer and metastasis to specific lymph nodes who have undergone neoadjuvant chemotherapy.
Not a fit: Patients with distant metastasis or a history of radiation therapy to the chest will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with advanced breast cancer.
How similar studies have performed: While there have been studies on radiation therapy in breast cancer, this specific approach of dose adaptation based on tumor biology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female with age 19 or older * Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy * Underwent neoadjuvant chemotherapy * Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy * Eastern Cooperative Oncology Group performance status 0-2 * Informed consent Exclusion Criteria: * Previous history of radiation therapy to the chest * Distant metastasis
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Haeyoung Kim, MD, PhD — Samsung Medical Center
- Study coordinator: Haeyoung Kim, MD, PhD
- Email: haeyoung0131.kim@samsung.com
- Phone: 82-2-3410-2612
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.