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Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
Conditions
Breast Carcinoma
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Partial breast irradiation
Type: Radiation
Name: Whole breast irradiation
Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Female
Criteria: 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
- 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
Location
The Danish Breast Cancer Cooperative Group
Copenhagen, Copenhagen Ø, Denmark
Status: Recruiting
Contact: Birgitte Offersen, MD, phd - +45 8949 3333 - bvo@oncology.dk
Start Date
May 2009
Completion Date
May 2022
Sponsors
Danish Breast Cancer Cooperative Group
Source
Danish Breast Cancer Cooperative Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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