Breast Cancer
Conditions
Keywords
Breast Cancer, intermediate-risk
Brief summary
The research hypothesis is that the tumor-free survival rate of intermediate-risk breast cancer patients exempted from RNI is not inferior to that of those receiving RNI. Patients with intermediate-risk breast cancer have a relatively low local-regional recurrence rate whether they undergo RNI or not.Patients were randomly assigned to the RNI group and the non-RNI group.After radiotherapy,the patients are followed the efficacy and toxicities of radiotherapy are evaluated.
Interventions
RADIATIONRegional nodal Radiotherapy
postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
RADIATIONNon-Regional nodal Radiotherapy
conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 or above * Undergo breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy * The surgical margin was negative * Tumor stage:Patients who receive direct surgery : pT1-2N1M0, with at least one lymph node having macrometastasis and a tumor risk score of 0-2.For those who underwent surgery after neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0 (cN+ with pathological confirmation), neoadjuvant Chemotherapy for ≥6 cycles.
Exclusion criteria
* distant metastasis * metastasis of ipsilateral internal mammary, supraclavicular or subclavian lymph nodes * Had received chest radiotherapy in the past * Bilateral breast cancer * Pregnancy or lactation period * Other malignant tumors in the past or at the same time, and the tumor-free survival time is less than 5 years (excluding non-malignant melanoma skin cancer, papillary thyroid carcinoma/follicular carcinoma, cervical carcinoma in situ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor-free survival rate | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| localregional recurrence | 5 year |
| overall survival | 5 year |
| acute toxicity | 6 months |
| late complication | 5 year |
Countries
China
Contacts
CONTACTShu-Lian Wang, M.D.
Outcome results
None listed