Postoperative radiation therapy for intermediate-risk breast cancer
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer: A Multicenter Prospective Randomized Phase III Trial and Cohort Study.
This study is testing if a specific type of radiation therapy after surgery can help people with intermediate-risk breast cancer have better outcomes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3142 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06757621 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of postoperative regional nodal irradiation (RNI) in patients with intermediate-risk breast cancer. It aims to determine whether RNI improves patient outcomes and to evaluate the efficacy and toxicity of two different radiation regimens: 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy. The study is designed as a Phase 3 interventional trial, focusing on patients who have undergone breast-conserving surgery or mastectomy with axillary lymph node dissection. The research addresses a gap in evidence regarding the benefits of RNI for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 and older with intermediate-risk breast cancer who have undergone surgery with negative margins.
Not a fit: Patients with low-risk breast cancer or those who have not undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for improved survival outcomes in patients with intermediate-risk breast cancer receiving postoperative radiation.
How similar studies have performed: Previous studies have shown safety and efficacy in similar radiation approaches, but this specific investigation into intermediate-risk patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥45 years old 2. Receiving breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy 3. Negative surgical margins 4. Tumor staging： A. patients without neoadjuvant chemotherapy: pT1-2N1M0, axillary lymph node dissection with 1-3 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) B. patients without neoadjuvant chemotherapy: pT1-2N1M0, sentinel lymph node biopsy with 1-2 metastatic lymph nodes, at least 1 lymph node with macroscopic metastasis, and a score of 0-2 according to the following risk factors: ≤40 years of age (1 point), tumour located in the inner quadrant (1 point), 2-3 lymph nodes positive in the axilla (1 point), presence of choroidal tumour thrombus (1 point), and restaging according to the 8th edition of the staging criteria (IB-IIA 1 point, and IIB-IIIA 2 points) C. patients with neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0, requiring positive clinical lymph nodes with pathological confirmation, receiving ≥6 cycles of neoadjuvant chemotherapy, and ≥3 sentinel lymph nodes detected for those with simple sentinel lymph node biopsy 5. Signed informed consent Exclusion Criteria: 1. Distant metastases 2. Metastasis to ipsilateral internal breast, supraclavicular or subclavicular lymph nodes 3. Previous radiotherapy to the chest 4. Bilateral breast cancer 5. Pregnancy, breastfeeding 6. Previous or concurrent other malignancy with tumor-free survival \<5 years (but excluding skin cancer with non-malignant melanoma, papillary/follicular thyroid cancer, cervical carcinoma in situ)
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Danqiong Wang
- Email: wdq1217ella@163.com
- Phone: 086-13535684351
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.