Breast CarcinomaNCT00892814
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
A study testing Partial breast irradiation and Whole breast irradiation in people with Breast Carcinoma, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Partial breast irradiation and Whole breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 882 participants
- Where
- 1 siteDenmark
- Study dates
- 14 May 2009to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- lobular carcinoma
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Danish Breast Cancer Cooperative Group
Copenhagen, Copenhagen Ø, DK-2100
About this study
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
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.
Read the 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.
- Conditions
- Breast Carcinoma
- Being tested
- Partial breast irradiation, Whole breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial breast irradiationRadiation
40 Gy/15 fractions, 3 weeks
Whole breast irradiationRadiation
40 Gy/15 fractions, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Partial breast irradiation | Experimental | 40 Gy/15 fractions, 3 weeks Receives: Radiation: Partial breast irradiation |
| Whole breast irradiation | Active comparator | 40 Gy/15 fractions, 3 weeks Receives: Radiation: Whole breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 and/or 3 fibrosis after radiotherapy
Measured: 3 years
Secondary outcomes (1)
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
morbidity and recurrences
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study start14 May 2009
- Primary completion7 Mar 2016
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO), Danish Cancer Society
- Responsible party
- Principal investigator, Birgitte Offersen, Danish Breast Cancer Cooperative Group
- Investigators
- Lars Stenbygaard, MD, Study chair, Aalborg University HospitalErik Jacobsen, MD, Study chair, Vejle HospitalMette H Nielsen, MD, phd, Study chair, Odense University HospitalAnders N Pedersen, MD, phd, Study chair, Copenhagen University Hospital, RigshospitaletBirgitte Offersen, MD, phd, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892814
- Sponsor's protocol ID
- DBCG PBI protocol
- Other IDs
- CIRRO IP030109
- Status last verified
- Feb 2020
- First submitted
- 4 May 2009
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18783840Offersen 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.
PubMed 35930754
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00892814
- Acronym / sponsor ID
- DBCG PBI protocol
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 882 participants (actual)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO), Danish Cancer Society
- Study start
- 14 May 2009
- Primary completion
- 7 Mar 2016 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial breast irradiation | Experimental | Radiation: Partial breast irradiation40 Gy/15 fractions, 3 weeks |
| Whole breast irradiation | Active comparator | Radiation: Whole breast irradiation40 Gy/15 fractions, 3 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- lobular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial breast irradiation40 Gy/15 fractions, 3 weeks | Radiation | Partial breast irradiation |
| Whole breast irradiation40 Gy/15 fractions, 3 weeks | Radiation | Whole breast irradiation |
Primary outcome
Grade 2 and/or 3 fibrosis after radiotherapy
Time frame: 3 years
1 secondary outcome
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 18783840Offersen 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.
- Derived from this study: PubMed 35930754Offersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Stenbygaard, MD study chair
Aalborg University Hospital
Erik Jacobsen, MD study chair
Vejle Hospital
Mette H Nielsen, MD, phd study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial breast irradiation and Whole breast irradiation in people with Breast Carcinoma, run by Danish Breast Cancer Cooperative Group at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 and/or 3 fibrosis after radiotherapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892814, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.