NCT03646955

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 926 (estimated)
• Sponsor: Danish Breast Cancer Cooperative Group · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Local Neoplasm Recurrence
• Distantly Metastatic Malignant Neoplasm
• Death
• Fibrosis Breast
• Depigmentation/Hyperpigmentation of Skin
• Telangiectasia
• Scar
• Pain
• PROMs

Interventions

Type	Name	Description
RADIATION	No partial breast irradiation	Omission of radiation therapy

Timeline

• Start date: 2018-09-05
• Primary completion: 2033-09-01
• Completion: 2035-09-01
• First posted: 2018-08-24
• Last updated: 2020-10-06

Locations

17 sites across 4 countries: Chile, Denmark, Norway, Sweden