Radiation Therapy for ypN0 Breast Cancer
Radiation Therapy for ypN0 Breast Cancer
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
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