Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIRRO IP030109 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Center for Interventional Research in Radiation Oncology (CIRRO) | OTHER |
| Danish Cancer Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial breast irradiation | Experimental | 40 Gy/15 fractions, 3 weeks |
|
| Whole breast irradiation | Active Comparator | 40 Gy/15 fractions, 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial breast irradiation | Radiation | 40 Gy/15 fractions, 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2 and/or 3 fibrosis after radiotherapy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival | morbidity and recurrences | 10 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Stenbygaard, MD | Aalborg University Hospital | Study Chair |
| Erik Jacobsen, MD | Vejle Hospital | Study Chair |
| Mette H Nielsen, MD, phd | Odense University Hospital | Study Chair |
| Anders N Pedersen, MD, phd | Rigshospitalet, Denmark | Study Chair |
| Birgitte Offersen, MD, phd | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Danish Breast Cancer Cooperative Group | Copenhagen | Copenhagen Ø | DK-2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18783840 | Background | Offersen BV, Overgaard M, Kroman N, Overgaard J. Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. Radiother Oncol. 2009 Jan;90(1):1-13. doi: 10.1016/j.radonc.2008.08.005. Epub 2008 Sep 8. | |
| 35930754 | Derived | Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Stenbygaard L, Pedersen AN, Thomsen MS, Yates E, Berg M, Lorenzen EL, Jensen I, Josipovic M, Jensen MB, Overgaard J; Danish Breast Cancer Group Radiotherapy Committee. Partial Breast Irradiation Versus Whole Breast Irradiation for Early Breast Cancer Patients in a Randomized Phase III Trial: The Danish Breast Cancer Group Partial Breast Irradiation Trial. J Clin Oncol. 2022 Dec 20;40(36):4189-4197. doi: 10.1200/JCO.22.00451. Epub 2022 Aug 5. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Whole breast irradiation |
| Radiation |
40 Gy/15 fractions, 3 weeks |
|
| D017437 |
| Skin and Connective Tissue Diseases |