Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer

This study is currently recruiting participants.

Verified by Danish Breast Cancer Cooperative Group, May 2009

First Received: May 4, 2009 No Changes Posted

Sponsors and Collaborators:	Danish Breast Cancer Cooperative Group CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology) Danish Cancer Society
Information provided by:	Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:	NCT00892814

Purpose

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.

Condition	Intervention	Phase
Breast Carcinoma	Radiation: Partial breast irradiation Radiation: Whole breast irradiation	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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

Further study details as provided by Danish Breast Cancer Cooperative Group:

Primary Outcome Measures:

Grade 2 and/or 3 fibrosis after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	628
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2022
Estimated Primary Completion Date:	May 2022 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Partial breast irradiation: Experimental 40 Gy/15 fractions, 3 weeks	Radiation: Partial breast irradiation 40 Gy/15 fractions, 3 weeks
Whole breast irradiation: Active Comparator 40 Gy/15 fractions, 3 weeks	Radiation: Whole breast irradiation 40 Gy/15 fractions, 3 weeks

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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892814

Contacts

Contact: Birgitte Offersen, MD, phd	+45 8949 3333	bvo@oncology.dk
Contact: Marie Overgaard, MD	+45 8949 3333	marie@oncology.dk

Locations

Denmark, Copenhagen Ø
The Danish Breast Cancer Cooperative Group	Recruiting
Copenhagen, Copenhagen Ø, Denmark, DK-2100
Contact: Birgitte Offersen, MD, phd +45 8949 3333 bvo@oncology.dk
Contact: Marie Overgaard, MD, phd +45 8949 3333 marie@oncology.dk
Principal Investigator: Maj-Britt Jensen

Sponsors and Collaborators

Danish Breast Cancer Cooperative Group

CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)

Danish Cancer Society

Investigators

Study Chair:	Lars Stenbygaard, MD	Aalborg Hospital
Study Chair:	Knud A Moeller, MD	Herning Hospital
Study Chair:	Erik Jacobsen, MD	Vejle Hospital
Study Chair:	Mette M Nielsen, MD, phd	Odense University Hospital
Study Chair:	Anders N Pedersen, MD, phd	Rigshospitalet, Denmark
Study Chair:	Kim Wedervang, MD	Naestved Hospital
Study Chair:	Peter M Vestlev, MD	Herlev Hospital
Study Chair:	Marie Overgaard, MD	Aarhus University Hospital
Principal Investigator:	Birgitte Offersen, MD, phd	Aarhus University Hospital

More Information

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. Epub 2008 Sep 8. Review.

Responsible Party:	Department of Oncology, Aarhus University Hospital, Aarhus ( Birgitte Offersen )
Study ID Numbers:	DBCG PBI protocol, CIRRO IP030109
Study First Received:	May 4, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00892814 History of Changes
Health Authority:	Denmark: The Radiotherapy Committee under The Danish Breast Cancer Cooperative Group

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases

Breast Neoplasms
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009