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)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Radiation: partial breast irradiation; Radiation: whole breast irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00907868

CDR0000636007

RECF0911

2008-A00494-51 (Other Identifier)

VA-2008/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,004 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,004 participants in 2 patient groups

Arm I

Active Comparator group

Description:

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

Treatment:

Radiation: whole breast irradiation

Arm II

Experimental group

Description:

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

Treatment:

Radiation: whole breast irradiation

Radiation: partial breast irradiation