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Trial Title:
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
NCT ID:
NCT00892814
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Partial breast irradiation
Description:
40 Gy/15 fractions, 3 weeks
Arm group label:
Partial breast irradiation
Intervention type:
Radiation
Intervention name:
Whole breast irradiation
Description:
40 Gy/15 fractions, 3 weeks
Arm group label:
Whole breast irradiation
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Danish Breast Cancer Cooperative Group
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Start date:
May 14, 2009
Completion date:
March 2026
Lead sponsor:
Agency:
Danish Breast Cancer Cooperative Group
Agency class:
Other
Collaborator:
Agency:
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Source:
Danish Breast Cancer Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00892814
