Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
2 other identifiers
interventional
882
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedStudy Start
First participant enrolled
May 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedFebruary 25, 2020
February 1, 2020
6.8 years
May 4, 2009
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Grade 2 and/or 3 fibrosis after radiotherapy
3 years
Secondary Outcomes (1)
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
10 years
Study Arms (2)
Partial breast irradiation
EXPERIMENTAL40 Gy/15 fractions, 3 weeks
Whole breast irradiation
ACTIVE COMPARATOR40 Gy/15 fractions, 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- lobular carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Danish Breast Cancer Cooperative Group
Copenhagen, Copenhagen Ø, DK-2100, Denmark
Related Publications (2)
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.
PMID: 18783840BACKGROUNDOffersen 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: 35930754DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
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
- PRINCIPAL INVESTIGATOR
Birgitte Offersen, MD, phd
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D., ass. professor
Study Record Dates
First Submitted
May 4, 2009
First Posted
May 5, 2009
Study Start
May 14, 2009
Primary Completion
March 7, 2016
Study Completion
March 1, 2026
Last Updated
February 25, 2020
Record last verified: 2020-02