Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer
Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer
Breast cancer patients operated with modified radical mastectomy or breast conservative
 surgery will be randomized for either adjuvant conventional radiotherapy versus
 hypofractionated radiotherapy for chest wall and axilla or breast and axilla.

 The patients will be recruited for one year and will be followed for 5 years by monitoring
 local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.
The investigators hypothesize that hypofractionated radiotherapy in node positive breast
 cancer is equally effective and safe as conventional fractionated radiotherapy. Breast cancer
 patients with pathological positive lymph nodes (N1 - N2) operated with modified radical
 mastectomy will be randomized 1:1 and also those with breast conservative surgery with
 positive lymph nodes will be randomized 1:1 for receiving either adjuvant conventional
 radiotherapy 200cgy x 25 fractions with 200cgy x 5 fractions boost for those with intact
 breast versus hypofractionated radiotherapy 266cgyx16 fractions and 266 cgy x 4 fractions
 boost for those with intact breast. The patients will be followed for 5 years to monitor
 locoregional recurrence, cosmetic outcomes, ipsilateral arm lymph edema. Health economic
 perspectives will be monitored by calculating cost effective analysis for both treatment
 plans.
Inclusion Criteria:

 1. ECOG. (Eastern Cooperative Oncology Group): 0-2

 2. Histologic documentation of invasive duct or lobular adenocarcinoma of the breast

 3. If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following
 definitive surgery

 4. If neoadjuvant chemotherapy was administered, pathology from the definitive surgery
 must confirm pathologic T1-3, N1-2 disease and also meet one of the following
 criteria:

 Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at
 presentation (ie, before neoadjuvant therapy) based on any of the following: Positive
 fine-needle aspiration (FNA), Positive core needle biopsy.

 5. Complete resection of known breast disease by one of the following surgeries
 Lumpectomy with axillary lymph node dissection with no more than 12 resected lymph
 nodes.

 Mastectomy and axillary lymph node dissection with no more than 12 resected lymph nodes.

 5- ER(estrogen-receptor), PR (progesterone-receptor), and HER2(human epidermal growth
 factor receptor 2) testing performed on the primary breast tumor; when applicable, testing
 must have been performed before receiving neoadjuvant chemotherapy.

 6-Margins of the resected specimen must be histologically free of invasive tumor and ductal
 carcinoma in situ (DCIS) as determined by the pathologist.

 7-The surgical wound should be completely healed without any signs of infection.

 8-Interval between the last surgery for breast cancer or the completion of adjuvant
 chemotherapy and study enrollment must be ≤ 56 days (ie, a maximum of 8 weeks).

 9-If adjuvant chemotherapy is received there should be at least 10 days gap between the
 last day of chemotherapy and the enrollment in the study to avoid skin toxicity.

 10-Women of child-bearing potential must agree to use a medically accepted form of
 pregnancy prevention for the duration of study treatment 11-Ability to understand and
 willingness to sign the consent form written in Arabic

 Exclusion Criteria:

 1. Patients with surgical margins less than or equal to 2mm.

 2. Patients with axillary dissection of more than 12 lymph nodes due to high incidence of
 arm lymphedema.

 3. Women with Huge pendulous breast.

 4. Patients with bad breast conservative surgery ( Surgery that impair the cosmetic
 outcome before starting radiotherapy).

 5. T4 tumors including inflammatory breast cancer.

 6. Known definitive clinical or radiologic evidence of metastatic disease.

 7. Patients re operated for microscopic positive margins after definitive surgery.

 8. Previous radiation therapy for the currently diagnosed breast cancer prior to study
 enrollment

 9. History of ipsilateral or contralateral breast or thoracic radiotherapy for any
 condition

 10. History of ipsilateral or contralateral axillary surgery for any condition

 11. History of lymphedema involving the ipsilateral or contralateral arm at present or at
 any time in the past

 12. Active collagen vascular disease, specifically dermatomyositis with a creatine
 phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus
 erythematosis, or scleroderma.

 13. Pregnancy or breastfeeding

 14. Second primary cancer.