Radiation Therapy for ypN0 Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04240548
• Other study ID #: NCI-BC-1/2016
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Regional Nodal Irradiation

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival	death from any cause	from randomization till death from any cause, assessed up to 10 years
Secondary	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