Clinical trial · Interventional
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial
NCT00892814CI-TRIAL-00043637unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial breast irradiation | Radiation | — | UNRESOLVED |
| Whole breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Partial breast irradiation
- description
- 40 Gy/15 fractions, 3 weeks
- interventionNames
- Radiation: Partial breast irradiation
- type
- ACTIVE_COMPARATOR
- label
- Whole breast irradiation
- description
- 40 Gy/15 fractions, 3 weeks
- interventionNames
- Radiation: Whole breast irradiation
Primary outcomes (1)
- measure
- Grade 2 and/or 3 fibrosis after radiotherapy
- timeFrame
- 3 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDOffersen 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. PMID 18783840
- DERIVEDOffersen 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. PMID 35930754