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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: Partial breast irradiation
40 Gy/15 fractions, 3 weeks
Radiation: Partial breast irradiation
40 Gy/15 fractions, 3 weeks
Active Comparator: Whole breast irradiation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: Birgitte Offersen, MD, phd         
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Danish Cancer Society
Investigators
Study Chair: Lars Stenbygaard, MD Aalborg Universityhospital
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
  More Information

Publications:
Responsible Party: Birgitte Offersen, M.D., Ph.D., ass. professor, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00892814     History of Changes
Other Study ID Numbers: DBCG PBI protocol, CIRRO IP030109
Study First Received: May 4, 2009
Last Updated: April 9, 2014
Health Authority: Denmark: The Radiotherapy Committee under The Danish Breast Cancer Cooperative Group

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2014