Radiation Therapy for ypN0 Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Regional Nodal Irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, regional nodal irradiation, preoperative chemotherapy
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
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm: A
Arm: B
Arm Description
regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
chest wall or whole breast only irradiation
Outcomes
Primary Outcome Measures
Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
axillary, internal mammary or supraclavicular recurrences
Secondary Outcome Measures
Disease Free survival
local recurrence, regional recurrence, distant recurrence, contralateral breast recurrence and second primary cancer
Overall Survival
death from any cause
Local Failure
chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy
Full Information
NCT ID
NCT04240548
First Posted
January 15, 2020
Last Updated
March 31, 2021
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04240548
Brief Title
Radiation Therapy for ypN0 Breast Cancer
Official Title
Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, regional nodal irradiation, preoperative chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm: A
Arm Type
Experimental
Arm Description
regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
Arm Title
Arm: B
Arm Type
No Intervention
Arm Description
chest wall or whole breast only irradiation
Intervention Type
Radiation
Intervention Name(s)
Regional Nodal Irradiation
Primary Outcome Measure Information:
Title
Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
Description
axillary, internal mammary or supraclavicular recurrences
Time Frame
time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years
Secondary Outcome Measure Information:
Title
Disease Free survival
Description
local recurrence, regional recurrence, distant recurrence, contralateral breast recurrence and second primary cancer
Time Frame
Time from randomization until local, regional or distant recurrence, assessed up to 10 years
Title
Overall Survival
Description
death from any cause
Time Frame
from randomization till death from any cause, assessed up to 10 years
Title
Local Failure
Description
chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy
Time Frame
from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiation Therapy for ypN0 Breast Cancer
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