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

Danish Breast Cancer Cooperative Group (DBCG)

Status: Active, not recruiting

Conditions: Breast Carcinoma

Treatments: Radiation: Partial breast irradiation; Radiation: Whole breast irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00892814

CIRRO IP030109

DBCG PBI protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 882 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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882 participants in 2 patient groups

Partial breast irradiation

Experimental group

Description:

40 Gy/15 fractions, 3 weeks

Treatment:

Radiation: Partial breast irradiation

Whole breast irradiation

Active Comparator group

Description:

40 Gy/15 fractions, 3 weeks

Treatment:

Radiation: Whole breast irradiation