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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Danish Breast Cancer Cooperative Group
Sponsor:
Collaborators:
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Danish Cancer Society
Information provided by (Responsible Party):
Birgitte Offersen, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:
NCT00892814
First received: May 4, 2009
Last updated: April 9, 2014
Last verified: April 2014

May 4, 2009
April 9, 2014
May 2009
May 2022   (final data collection date for primary outcome measure)
Grade 2 and/or 3 fibrosis after radiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00892814 on ClinicalTrials.gov Archive Site
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Carcinoma
  • Radiation: Partial breast irradiation
    40 Gy/15 fractions, 3 weeks
  • Radiation: Whole breast irradiation
    40 Gy/15 fractions, 3 weeks
  • Experimental: Partial breast irradiation
    40 Gy/15 fractions, 3 weeks
    Intervention: Radiation: Partial breast irradiation
  • Active Comparator: Whole breast irradiation
    40 Gy/15 fractions, 3 weeks
    Intervention: Radiation: Whole breast irradiation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
628
May 2022
May 2022   (final data collection date for primary outcome measure)

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
Female
60 Years and older
No
Contact: Birgitte Offersen, MD, phd +45 8949 3333 bvo@oncology.dk
Contact: Marie Overgaard, MD +45 8949 3333 marie@oncology.dk
Denmark
 
NCT00892814
DBCG PBI protocol, CIRRO IP030109
Yes
Birgitte Offersen, Danish Breast Cancer Cooperative Group
Danish Breast Cancer Cooperative Group
  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)
  • Danish Cancer Society
Study Chair: Lars Stenbygaard, MD Aalborg Universitetshospital
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
Danish Breast Cancer Cooperative Group
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP