Clinical trial NCT00892814: Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
Official title: Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
name: Danish Cancer Society
First posted: 2009-05-05
Enrollment: 882
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade 2 and/or 3 fibrosis after radiotherapy
timeFrame: 3 years
Secondary outcomes:
measure: Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Danish Breast Cancer Cooperative Group
state: Copenhagen Ø
Study officials:
affiliation: Aalborg University Hospital
name: Lars Stenbygaard, MD
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Erik Jacobsen, MD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Mette H Nielsen, MD, phd
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Anders N Pedersen, MD, phd
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Birgitte Offersen, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.