Clinical trial NCT00907868: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 2004
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Time to recurrence
timeFrame: up to 15 years of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: David Azria, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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