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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: partial breast irradiation
* Radiation: whole breast irradiation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | up to 15 years of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ