Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
February 24, 2020 updated by: Birgitte Offersen, Danish Breast Cancer Cooperative Group
Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
882
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Copenhagen Ø
-
Copenhagen, Copenhagen Ø, Denmark, DK-2100
- The Danish Breast Cancer Cooperative Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Partial breast irradiation
40 Gy/15 fractions, 3 weeks
|
40 Gy/15 fractions, 3 weeks
|
|
ACTIVE_COMPARATOR: Whole breast irradiation
40 Gy/15 fractions, 3 weeks
|
40 Gy/15 fractions, 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Grade 2 and/or 3 fibrosis after radiotherapy
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time Frame: 10 years
|
morbidity and recurrences
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Erik Jacobsen, MD, Vejle Hospital
- Study Chair: Anders N Pedersen, MD, phd, Rigshospitalet, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Radiother Oncol. 2011 Feb;98(2):254. Radiother Oncol. 2011 May;99(2):254.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 14, 2009
Primary Completion (ACTUAL)
March 7, 2016
Study Completion (ANTICIPATED)
March 1, 2026
Study Registration Dates
First Submitted
May 4, 2009
First Submitted That Met QC Criteria
May 4, 2009
First Posted (ESTIMATE)
May 5, 2009
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBCG PBI protocol
- CIRRO IP030109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.