Breast Cancer
Conditions
Keywords
breast cancer, positive sentinel lymph nodes, axillary radiotherapy
Brief summary
This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
Detailed description
Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.
Interventions
RADIATIONaxillary radiotherapy
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female * 18\ 70 years old * Pathologically confirmed invasive breast cancer * A clinical T1-2N0M0 tumor * Treated with breast conserving surgery and sentinel lymph node biopsy * 1\ 2 positive sentinel lymph nodes, including micro-metastases or macro-metastases. * ECOG score 1\ 2 * Written informed consent
Exclusion criteria
* Patients underwent complete axillary lymph node dissection * Patients underwent mastectomy * Patients underwent neoadjuvant therapy * Clinically node positive pre-operative * Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years * Previous radiation therapy of breast or thorax * Medical contraindication for radiotherapy * Prior axillary surgery or radiotherapy * Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axillary recurrence | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Local-regional recurrence | 5 years |
| Disease free survival | 5 years |
| Overall survival | 5 years |
| Complications | baseline，1，2，3，4，5 years |
Countries
China
Contacts
Primary ContactXiaoli Yu, MD.PhD
Backup ContactZhaozhi Yang, MD.PhD
Outcome results
None listed