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

Not Applicable

Active, not recruiting

• Conditions: Breast Carcinoma
• Interventions: Radiation: Whole breast irradiation; Radiation: Partial breast irradiation

• Registration Number: NCT00892814
• Lead Sponsor: Danish Breast Cancer Cooperative Group

Brief 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.

Study Timeline

• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Study Start: 2009-05-14
• Primary Completion: 2016-03-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 882

Inclusion Criteria

• women 60 years or older
• operated for unilateral, unifocal early breast cancer pT1, pN0, M0, grade I or II, positive estrogen and/or progesterone receptor, HER2 negative

Exclusion Criteria

• lobular carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole breast irradiation	Whole breast irradiation	40 Gy/15 fractions, 3 weeks
Partial breast irradiation	Partial breast irradiation	40 Gy/15 fractions, 3 weeks

Primary Outcome Measures

Name	Time	Method
Grade 2 and/or 3 fibrosis 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	morbidity and recurrences

Trial Locations

Locations (1)

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