Breast-Conserving Surgery and Whole-Breast Radiation Therapy With or Without Additional Radiation Therapy to the Tumor in Treating Women With Ductal Carcinoma in Situ (BONBIS) (BONBIS)

February 3, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Estimate and compare local recurrence-free survival of women with ductal breast carcinoma in situ (DCIS) treated with breast-conserving surgery followed by whole breast irradiation with vs without a radiation tumor bed boost.

Secondary

  • Compare relapse-free survival between the two arms.
  • Compare overall survival.
  • Compare acute and late toxicities.
  • Compare cosmetic results and quality of life.
  • Identify patients at risk for late toxicities using a biological test.

Tertiary

  • Store blood samples at the CEPH (French Center of the Human Polymorphism Center) for polymorphism analyses.

OUTLINE: This is a multicenter study. All patients undergo breast-conserving surgery (after a single intervention or second excision) with a margin ≥ 1 mm. A superficial or deep margin is acceptable if the surgery has left the skin tissue or the fascia pectoral muscle, respectively. Twelve weeks later, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5 weeks.
  • Arm II: Patients undergo WBI as in arm I. Patients also undergo a radiation tumor bed boost once daily for 8 fractions (weekdays only) over 2 weeks.

Quality of life will be assessed.

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually for 10 years.

Study Type

Interventional

Enrollment (Actual)

2004

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

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ of the breast

    • No invasive component
    • No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done)
    • No local recurrence of a primary breast cancer
    • No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm
  • Has undergone bilateral mammography within 6 months before randomization

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 5 years
  • Not pregnant
  • Available for long-term follow up
  • No history of in situ carcinoma in the contralateral breast
  • No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No uncontrolled cardiac, renal, or pulmonary disease
  • No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)
  • No HIV positivity
  • Affiliated with the social health system
  • No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
Radiation: whole breast irradiation
Patients undergo whole breast irradiation
Experimental: Arm II
Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
Radiation: whole breast irradiation
Patients undergo whole breast irradiation
Radiation: partial breast irradiation
Patients undergo radiation tumor bed boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: up to 15 years of follow up
up to 15 years of follow up

Collaborators and Investigators

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Principal Investigator: David Azria, MD, PhD, Institut du Cancer de Montpellier - Val d'aurelle

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

Helpful Links

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 (Actual)

November 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimated)

May 25, 2009

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000636007
  • RECF0911 (Registry Identifier: INCA)
  • VA-2008/25 (Other Identifier: Organization protocol ID)
  • 2008-A00494-51 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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