NCT00892814

Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer

Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Danish Breast Cancer Cooperative Group · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.

Detailed description

The study is 2-armed. In both treatment arms the radiotherapy consists of 40 Gy in 15 fractions, 2.67 Gy per fraction. The primary endpoint in the trial is late radiation morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate of local recurrence and an attempt to establish a genetic risk profile for development of late radiation morbidity. The hypothesis is that women operated with breast conservation for a breast carcinoma with low risk of local recurrence can be offered partial breast irradiation without risking more late radiation morbidity compared to whole breast irradiation.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
RADIATION	Partial breast irradiation	40 Gy/15 fractions, 3 weeks
RADIATION	Whole breast irradiation	40 Gy/15 fractions, 3 weeks

Timeline

• Start date: 2009-05-14
• Primary completion: 2016-03-07
• Completion: 2026-03-01
• First posted: 2009-05-05
• Last updated: 2020-02-25

Locations

1 site across 1 country: Denmark