Breast Cancer
Conditions
Keywords
breast cancer, mastectomy, one to three positive nodes, radiotherapy
Brief summary
The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.
Detailed description
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
Interventions
RADIATIONradiation
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
RADIATIONno radiation
no radiotherapy
Sponsors
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Ipsilateral histologically confirmed invasive breast cancer * Undergone total mastectomy and axillary dissection * T1-2 and one to three axillary lymph nodes positive * A minimum of 10 axillary nodes dissected * Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation * Written,informed consent
Exclusion criteria
* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * Previous or concurrent malignant other than non-melanomatous skin cancer * Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 10 years |
Secondary
| Measure | Time frame |
|---|---|
| loco-regional recurrence | 5 years |
Countries
China
Outcome results
None listed