Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event. Distant metastasis will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years.

Defined as the interval from the date of randomization to any disease recurrence or death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

Defined as the interval from the date of randomization to death or last visit. It will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received and every year thereafter through 10 years

Late toxicity (development of sclerosis in irradiated area and ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment and every year through 10 years following the completion of radiotherapy

Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA before treatment and every year through 10 years following the completion of radiotherapy

Arm lymphedema defined as ≥10% increase in the treated arm circumference over baseline circumference compared to the contralateral arm. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be measured before treatment and every year through 10 years following the completion of radiotherapy at every time point

Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or Abduction. Shoulder movement (Range of motion of the shoulders) will be assessed before treatment and every year through 10 years following the completion of radiotherapy

Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT. It will be assessed before treatment and every year through 10 years following the completion of radiotherapy

Brachial plexopathy will be documented if damage to the brachial plexus is suspected and patients have symptoms of pain, paresthesia, numbness, or other symptoms. Suspected cases of brachial plexopathy will be subject to confirmation by neurophysiological assessment. Brachial plexopathy will be assessed before treatment and every year through 10 years following the completion of radiotherapy

For patients received mastectomy and reconstruction, the following complications will be assessed before treatment and every year through 10 years following the completion of radiotherapy: capsular contraction, partial or entire flap necrosis or loss, implant leakage and rupture, implant exposure, infection, hematoma/seroma and secondary surgical intervention

The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor; comparing the reconstructed breast to the control breast. Excellent, there is minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast. The cosmetic outcomes will be assessed before treatment and every year through 10 years following the completion of radiotherapy. The breast cosmetic outcome will be measured by Harvard 4 scale (poor, fair, good, excellent) evaluation system

Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy

Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23) before treatment, the end of treatment, and every year through 10 years following the completion of radiotherapy