Radiation Therapy for ypN0 Breast Cancer

Study Overview
=================
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

Official Title
-----------------
Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Regional Nodal Irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm: A<br>regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation | Radiation: Regional Nodal Irradiation<br> <br> |
| No Intervention: Arm: B<br>chest wall or whole breast only irradiation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences ) | axillary, internal mammary or supraclavicular recurrences | time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free survival | local recurrence, regional recurrence, distant recurrence, contralateral breast recurrence and second primary cancer | Time from randomization until local, regional or distant recurrence, assessed up to 10 years | 
| Overall Survival | death from any cause | from randomization till death from any cause, assessed up to 10 years | 
| Local Failure | chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy | from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, regional nodal irradiation, preoperative chemotherapy