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)

NCT ID: NCT00907868

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2004 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2029-10-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).

Group Type: ACTIVE_COMPARATOR

whole breast irradiation

Intervention Type: RADIATION

Patients undergo whole breast irradiation

Arm II

Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).

Group Type: EXPERIMENTAL

partial breast irradiation

Intervention Type: RADIATION

Patients undergo radiation tumor bed boost

whole breast irradiation

Intervention Type: RADIATION

Patients undergo whole breast irradiation

Interventions

partial breast irradiation

Patients undergo radiation tumor bed boost

Intervention Type: RADIATION

whole breast irradiation

Patients undergo whole breast irradiation

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Azria, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Countries

France

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Related Links

https://www.e-cancer.fr/Professionnels-de-sante/Le-registre-des-essais-cliniques/Le-registre-des-essais-cliniques/Etudes-cliniques/BONBIS-Essai-de-phase-3-randomise-evaluant-l-efficacite-d-un-complement-de-radiotherapie-apres-traitement-conservateur-chez-des-patientes-ayant-un-cancer-du-sein.-essai-clos-aux-inclusions

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

RECF0911

Identifier Type: REGISTRY

Identifier Source: secondary_id

VA-2008/25

Identifier Type: OTHER

Identifier Source: secondary_id

2008-A00494-51

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000636007

Identifier Type: -

Identifier Source: org_study_id