Radiation Therapy for ypN0 Breast Cancer

National Cancer Institute, Egypt

Status and phase

Unknown

Phase 3

Conditions

Breast Cancer

Treatments

Radiation: Regional Nodal Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT04240548

NCI-BC-1/2016

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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