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Radiation Therapy for ypN0 Breast Cancer

N

National Cancer Institute, Egypt

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer

Treatments

Radiation: Regional Nodal Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT04240548
NCI-BC-1/2016

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Arm: A
Experimental group
Description:
regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation
Treatment:
Radiation: Regional Nodal Irradiation
Arm: B
No Intervention group
Description:
chest wall or whole breast only irradiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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