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)
partial breast irradiationwhole breast irradiation
partial breast irradiation: Patients undergo radiation tumor bed boost
whole breast irradiation: Patients undergo whole breast irradiation
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Time to recurrence — up to 15 years of follow up
Trial sites (1)
Facility
City
Region
Status
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier
France
More Institut du Cancer de Montpellier - Val d'Aurelle trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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