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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00892814
Recruitment Status : Active, not recruiting
First Posted : May 5, 2009
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Breast Carcinoma Radiation: Partial breast irradiation Radiation: Whole breast irradiation

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2009
Primary Completion Date : March 2016
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Grade 2 and/or 3 fibrosis after radiotherapy [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival [ Time Frame: 10 years ]
    morbidity and recurrences


Eligibility Criteria

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892814


Locations
Denmark
The Danish Breast Cancer Cooperative Group
Copenhagen, Copenhagen Ø, Denmark, DK-2100
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 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
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
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

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