An interventional study of No partial breast irradiation in Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm and Death, sponsored by Danish Breast Cancer Cooperative Group. Recruiting at 17 sites in 4 countries. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment
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.
International standard of therapy is to provide adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer to lower the risk of local and distant failures. However, breast cancer is a heterogeneous disease, and the gain from RT in selected low risk patients is low. RT may cause acute and late side effects, and some of these may be serious to the patient. Therefore, there is a need to tailor RT utilization to the individual recurrence risk and try identify patients who are unlikely to gain much risk reduction from RT, because those patients can then omit RT and thereby avoid late effects and over-treatment. At the present time there is no consensus as to define the selection criteria for patients who may omit RT.
Based on early results from the randomized DBCG RT PBI trial, external beam 40 Gy/15 fr partial breast irradiation (PBI) has been standard in Denmark since April 2016 for selected low risk breast cancer patients. Based on results from the UK IMPORT LOW trial, the 5 yr local recurrence risk using this technique for PBI is 0.5%, whilst 2% for developing a new contralateral breast cancer.
This trial will investigate if PBI can safely be omitted in selected low risk breast cancer patients without causing unacceptable high risk of local failure.
Female patient >=60 years
Primary tumour characteristics by conventional histopathology
Surgical type is breast conservation
Performance status ECOG 0-2
No evidence of distant metastasis
Exclusion Criteria:
External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
Radiation: No partial breast irradiation
No radiation therapy
Omission of radiation therapy
Invasive local recurrence
Invasive local recurrence
Time frame: 10 years
Regional nodes recurrence
Invasive recurrence in regional nodes of the treated breast
Time frame: 10 years
Distant failure
Invasive recurrence from the breast cancer outside the loco-regional area
Time frame: 10 years
Death
Death and cause of death
Time frame: 10 years
Plan to share: Yes — When the results from the trial are published, the DBCG RT Committee can decide that the results may be part of a meta-analysis.
Supporting information: Study protocol
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Danish Breast Cancer Cooperative Group