Radiation Therapy for ypN0 Breast Cancer

Phase 3

• Conditions: Breast Cancer
• Interventions: Radiation: Regional Nodal Irradiation

• Registration Number: NCT04240548
• Lead Sponsor: National Cancer Institute, Egypt

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm: A	Regional Nodal Irradiation	regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt