Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

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.

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