Overview

This trial is active, not recruiting.

Condition breast carcinoma
Treatments partial breast irradiation, whole breast irradiation
Phase phase 2
Sponsor Danish Breast Cancer Cooperative Group
Collaborator Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Start date May 2009
End date March 2016
Trial size 882 participants
Trial identifier NCT00892814, CIRRO IP030109, DBCG PBI protocol

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
40 Gy/15 fractions, 3 weeks
partial breast irradiation
40 Gy/15 fractions, 3 weeks
(Active Comparator)
40 Gy/15 fractions, 3 weeks
whole breast irradiation
40 Gy/15 fractions, 3 weeks

Primary Outcomes

Measure
Grade 2 and/or 3 fibrosis after radiotherapy
time frame: 3 years

Secondary Outcomes

Measure
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
time frame: 10 years

Eligibility Criteria

Female participants at least 60 years old.

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

Additional Information

Official title Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial
Principal investigator Birgitte Offersen, MD, phd
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Danish Breast Cancer Cooperative Group.