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

February 24, 2020 updated by: Birgitte Offersen, Danish Breast Cancer Cooperative Group

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

882

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen Ø
      • Copenhagen, Copenhagen Ø, Denmark, DK-2100
        • The Danish Breast Cancer Cooperative Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade 2 and/or 3 fibrosis after radiotherapy
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time Frame: 10 years
morbidity and recurrences
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Breast Cancer Cooperative Group

Collaborators

Danish Cancer Society
Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Investigators

  • Study Chair: Erik Jacobsen, MD, Vejle Hospital
  • Study Chair: Anders N Pedersen, MD, phd, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 14, 2009

Primary Completion (ACTUAL)

March 7, 2016

Study Completion (ANTICIPATED)

March 1, 2026

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (ESTIMATE)

May 5, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBCG PBI protocol
  • CIRRO IP030109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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