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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
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, regional nodal irradiation, preoperative chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 15, 2020
Last Updated
March 31, 2021
Sponsor
National Cancer Institute, Egypt
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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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