Irradiation of internal mammary lymph nodes in high-risk breast cancer patients after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Yong Yang, MD — Fujian Medical University Union Hospital
• Study coordinator: Yong Yang, M.S
• Email: dr_yangyong1983@163.com
• Phone: 18813019084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.