Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages 20-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
ECOG. (Eastern Cooperative Oncology Group): 0-2
Histologic documentation of invasive duct or lobular adenocarcinoma of the breast
If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 followingdefinitive surgery
If neoadjuvant chemotherapy was administered, pathology from the definitive surgerymust confirm pathologic T1-3, N1-2 disease and also meet one of the followingcriteria: Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement atpresentation (ie, before neoadjuvant therapy) based on any of the following: Positivefine-needle aspiration (FNA), Positive core needle biopsy.
Complete resection of known breast disease by one of the following surgeriesLumpectomy with axillary lymph node dissection with no more than 12 resected lymphnodes. 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 growthfactor receptor 2) testing performed on the primary breast tumor; when applicable, testingmust have been performed before receiving neoadjuvant chemotherapy.
6-Margins of the resected specimen must be histologically free of invasive tumor and ductalcarcinoma 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 adjuvantchemotherapy 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 thelast 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 ofpregnancy prevention for the duration of study treatment 11-Ability to understand andwillingness to sign the consent form written in Arabic
Exclusion
Exclusion Criteria:
Patients with surgical margins less than or equal to 2mm.
Patients with axillary dissection of more than 12 lymph nodes due to high incidence ofarm lymphedema.
Women with Huge pendulous breast.
Patients with bad breast conservative surgery ( Surgery that impair the cosmeticoutcome before starting radiotherapy).
T4 tumors including inflammatory breast cancer.
Known definitive clinical or radiologic evidence of metastatic disease.
Patients re operated for microscopic positive margins after definitive surgery.
Previous radiation therapy for the currently diagnosed breast cancer prior to studyenrollment
History of ipsilateral or contralateral breast or thoracic radiotherapy for anycondition
History of ipsilateral or contralateral axillary surgery for any condition
History of lymphedema involving the ipsilateral or contralateral arm at present or atany time in the past
Active collagen vascular disease, specifically dermatomyositis with a creatinephosphokinase (CPK) level above normal or with an active skin rash, systemic lupuserythematosis, or scleroderma.
Pregnancy or breastfeeding
Second primary cancer.
Study Design
Study Description
Connect with a study center
Mahmoud Ellithy
Cairo, Abbasia 14031
EgyptActive - Recruiting
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