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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-14

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Partial breast irradiation

40 Gy/15 fractions, 3 weeks

Group Type EXPERIMENTAL

Partial breast irradiation

Intervention Type RADIATION

40 Gy/15 fractions, 3 weeks

Whole breast irradiation

40 Gy/15 fractions, 3 weeks

Group Type ACTIVE_COMPARATOR

Whole breast irradiation

Intervention Type RADIATION

40 Gy/15 fractions, 3 weeks

Interventions

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Partial breast irradiation

40 Gy/15 fractions, 3 weeks

Intervention Type RADIATION

Whole breast irradiation

40 Gy/15 fractions, 3 weeks

Intervention Type RADIATION

Eligibility Criteria

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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