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

  • Egypt
      • 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
Radiation: Regional Nodal 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
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

National Cancer Institute, Egypt

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

Keywords

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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