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Radiation Therapy for ypN0 Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240548
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt

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

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Regional Nodal Irradiation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Overall Survival [ Time Frame: from randomization till death from any cause, assessed up to 10 years ]
    death from any cause

  3. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240548


Locations
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Egypt
National Cancer Institute
Cairo, Egypt, 11796
Sponsors and Collaborators
National Cancer Institute, Egypt
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Responsible Party: Rimoun Ramsis Anis Boutrus, Lecturer of Radiation Oncology, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04240548    
Other Study ID Numbers: NCI-BC-1/2016
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt:
breast cancer
regional nodal irradiation
preoperative chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases