Irradiation of internal mammary lymph nodes in high-risk breast cancer patients after chemotherapy
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial
This study tests if adding radiation to the internal mammary lymph nodes can help high-risk breast cancer patients who have already had chemotherapy live longer without their cancer coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 722 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06559696 on ClinicalTrials.gov |
What this trial studies
This phase 3 trial investigates the effects of internal mammary nodal irradiation (IMNI) on disease-free survival in high-risk breast cancer patients who have undergone neoadjuvant chemotherapy. Participants with axillary lymph node-positive or supra/subclavicular lymph node metastasis are randomly assigned to receive either IMNI or no IMNI in addition to standard breast or chest wall irradiation. The study aims to determine if adding IMNI improves outcomes for these patients compared to those who do not receive this treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed invasive breast cancer who have undergone neoadjuvant chemotherapy and have specific lymph node involvement.
Not a fit: Patients with distant metastases or those who have not received neoadjuvant chemotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve disease-free survival rates for high-risk breast cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific intervention is novel and aims to provide new insights into treatment efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed invasive breast cancer * Underwent neoadjuvant chemotherapy * Eastern Cooperative Oncology Group Performance Status Scale 0-2 * ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy * No distant metastases * No internal mammary nodes metastases based on images before system therapy * Willing to follow up * Written,informed consent Exclusion Criteria: * Without neoadjuvant chemotherapy * Distant metastases * Simultaneous bilateral breast cancer * Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy * Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Yong Yang, M.S — Fujian Medical University Union Hospital
- Study coordinator: Yong Yang, M.S
- Email: dr_yangyong1983@163.com
- Phone: 18813019084
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.