Radiation therapy tailored to tumor biology for advanced breast cancer
Official title: Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
Run by Samsung Medical Center · NCT05896865 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 16, 2023 |
| Main results expected | March 16, 2028 |
| Study ends | March 16, 2030 |
| Registry record updated | June 29, 2025 |
| Trial ID | NCT05896865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with distant metastasis or a history of radiation therapy to the chest will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on radiation therapy in breast cancer, this specific approach of dose adaptation based on tumor biology is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Capecitabine for MRD-positive, resected ER+/HER2-negative breast cancer
This Phase 2 trial tests whether taking capecitabine can help people with resected, ER-positive/HER2-negative breast cancer who still have molecular residual disease after standard therapy.
-
Biobran (rice bran arabinoxylan) supplement to support breast cancer chemotherapy
This will test whether taking 3 grams daily of Biobran for 24 weeks helps women with stage I–III breast cancer tolerate paclitaxel and doxorubicin chemotherapy and have fewer side effects.
-
Meaning-Centered Therapy for Latinos for adults with advanced cancer
This study tests whether Meaning-Centered Psychotherapy for Latinos (MCP-L) can reduce anxiety and depression and improve quality of life compared with CBT in Spanish-speaking adults with advanced cancer.
-
SBRT with intratumoural pembrolizumab before neoadjuvant chemotherapy for high-risk breast cancer
This study will test whether a short course of focused radiation plus two injections of pembrolizumab into the tumor before chemotherapy helps people with high‑risk invasive breast cancer respond better to treatment.
-
Predicting how hormone therapy before surgery affects breast cancer
This study is testing how hormone therapy before surgery can help people with early-stage breast cancer and what it means for their tumors.
-
Meal timing during cancer treatment for Alaska Native and American Indian patients
This test will see if an 8-hour time-restricted eating schedule during neoadjuvant or adjuvant therapy helps Alaska Native and American Indian adults with rectal or certain breast cancers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.