Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2016-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm: A
regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
Regional Nodal Irradiation
Arm: B
chest wall or whole breast only irradiation
No interventions assigned to this group
Interventions
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Regional Nodal Irradiation
Eligibility Criteria
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Inclusion Criteria
* Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis
* Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan
* Pathologic confirmation using, FNAC, core biopsy or excisional biopsy
* ER, PR, Her2 neu and Ki67 status should be available for all patients
* All patients should have received standard preoperative chemotherapy prior to surgery
* At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla
* Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization
Exclusion Criteria
* Definitive clinical or radiologic evidence of metastatic disease
* T4 tumors including inflammatory breast cancer
* N3 disease detected clinically or by imaging
* Patients with histologically positive axillary nodes after preoperative chemotherapy
* Positive surgical margin after definitive surgery
* Previous ipsilateral or contralateral breast cancer
* Previous chest wall or breast irradiation
* Second primary cancer
* Active connective tissue disease
18 Years
70 Years
FEMALE
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Rimoun Ramsis Anis Boutrus
Lecturer of Radiation Oncology
Locations
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National Cancer Institute
Cairo, , Egypt
Countries
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Other Identifiers
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NCI-BC-1/2016
Identifier Type: -
Identifier Source: org_study_id
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