NCT06559696 Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy
| NCT ID | NCT06559696 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 722 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2032-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 722 participants in total. It began in 2024-07-15 with a primary completion date of 2032-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.
Eligibility 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
Contact & Investigator
Yong Yang, M.S
PRINCIPAL INVESTIGATOR
Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT06559696 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06559696 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 722 participants.
Is NCT06559696 currently recruiting?
Yes, NCT06559696 is actively recruiting participants. Contact the research team at dr_yangyong1983@163.com for enrollment information.
Where is the NCT06559696 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06559696 clinical trial?
NCT06559696 is sponsored by Fujian Medical University Union Hospital. The principal investigator is Yong Yang, M.S at Fujian Medical University Union Hospital. The trial plans to enroll 722 participants.
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