Radiation Therapy for ypN0 Breast Cancer

NCT04240548 | Unknown Phase 3

• 1 other identifier: NCI-BC-1/2016
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast cancer; regional nodal irradiation; preoperative chemotherapy

Outcome Measures

Primary Outcomes (1)

• Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )

  axillary, internal mammary or supraclavicular recurrences

  time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years

Secondary Outcomes (3)

• Disease Free survival

  Time from randomization until local, regional or distant recurrence, assessed up to 10 years

• Overall Survival

  from randomization till death from any cause, assessed up to 10 years

• Local Failure

  from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years

Study Arms (2)

Arm: A

EXPERIMENTAL

regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation

Radiation: Regional Nodal Irradiation

Arm: B

NO INTERVENTION

chest wall or whole breast only irradiation

Interventions

Regional Nodal Irradiation RADIATION

Arm: A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Radiation Oncology

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)