Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer; Carcinoma in Situ of the Breast
• Interventions: Radiation: standard fractionated radiotherapy; Radiation: hypofractionated radiotherapy

• Registration Number: NCT00909818
• Lead Sponsor: Danish Breast Cancer Cooperative Group

Brief Summary

The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

Detailed Description

The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.

The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.

Study Timeline

• Study Start: 2009-05-14
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 976

Inclusion Criteria

• operated with breast conserving strategy for:

  1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
  2. carcinoma in situ of the breast

Exclusion Criteria

• previous radiation of the breast/thorax
• breast implants
• pregnant/lactating
• comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard fractionated radiotherapy	standard fractionated radiotherapy	50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
hypofractionated radiotherapy	hypofractionated radiotherapy	hypofractionated radiotherapy 40 Gy/15 fractions

Primary Outcome Measures

Name	Time	Method
Grade 2 or 3 fibrosis 3 years after radiotherapy	3 years

Secondary Outcome Measures

Name	Time	Method
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival	10 years

Trial Locations

Locations (1)

The Danish Breast Cancer Cooperative Group; 🇩🇰 Copenhagen, Denmark