- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240548
Radiation Therapy for ypN0 Breast Cancer
March 31, 2021 updated by: Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt
Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 11796
- National Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm: A
regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
|
|
No Intervention: Arm: B
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 )
Time Frame: time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years
|
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
Time Frame: 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
|
Time from randomization until local, regional or distant recurrence, assessed up to 10 years
|
Overall Survival
Time Frame: from randomization till death from any cause, assessed up to 10 years
|
death from any cause
|
from randomization till death from any cause, assessed up to 10 years
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Local Failure
Time Frame: 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
|
from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 23, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 31, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-BC-1/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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