Breast Cancer
Conditions
Keywords
breast cancer, regional nodal irradiation, preoperative chemotherapy
Brief summary
This is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy
Interventions
RADIATIONRegional Nodal Irradiation
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* WHO performance status 0-1 * 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
* Poor performance status * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences ) | time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years | axillary, internal mammary or supraclavicular recurrences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free survival | Time from randomization until local, regional or distant recurrence, assessed up to 10 years | local recurrence, regional recurrence, distant recurrence, contralateral breast recurrence and second primary cancer |
| Overall Survival | from randomization till death from any cause, assessed up to 10 years | death from any cause |
| Local Failure | from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years | chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy |
Countries
Egypt
Outcome results
None listed