Radiation therapy for high-risk breast cancer patients
Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
This study tests if adding radiation to the lymph nodes along with chest and whole breast radiation can help women with high-risk breast cancer live longer without their cancer coming back after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1355 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05976412 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of regional lymph node irradiation combined with chest and whole breast radiation on improving the 5-year disease-free survival rate in patients with high-risk pN0 breast cancer. It is a non-blind, randomized controlled trial that includes female patients over 18 who have undergone radical surgery for breast cancer. The study aims to determine if this combined radiotherapy approach can significantly enhance patient outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 years old with high-risk pN0 breast cancer who have undergone radical surgery.
Not a fit: Patients who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved long-term survival rates for patients with high-risk breast cancer.
How similar studies have performed: Similar studies have shown promise in improving outcomes for breast cancer patients through targeted radiotherapy, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Voluntarily participate and sign an informed consent form; Age\>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors \[tumor size (\>2cm), tumor site (medial and central quadrants), Ki-67 level (\>14%), and vascular status (positive)\]; KPS ≥ 80, estimated survival time \>5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study Exclusion Criteria: Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dan Ou, MD
- Email: od12341@rjh.com.cn
- Phone: 8618801970632
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.