About this trial
All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
unilateral and unifocal non-lobular histology grade 1-2
maximum microscopic size <=20mm
node negative determined by sentinel node or axillary lymph node dissection
estrogen receptor >=10% positive
Disqualifiers
multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
evidence of clinical or pathological T4 breast cancer
grade 3 malignancy
previous breast cancer or DCIS irrespective of disease-free interval
Trial design
Parallel
Treatments tested in this trial
No partial breast irradiation
RadiationOmission of radiation therapy
Treatment groups
Trial outcomes
Primary outcomes
Invasive local recurrence
Invasive local recurrence
Secondary outcomes
Regional nodes recurrence
Invasive recurrence in regional nodes of the treated breast
Distant failure
Invasive recurrence from the breast cancer outside the loco-regional area
Death
Death and cause of death
Sponsors and contacts
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Danish Breast Cancer Cooperative Group
Lead sponsor
Danish Cancer Society
Collaborator
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Collaborator