Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

Istituto Clinico Humanitas

Status and phase: Terminated; Phase 2

Conditions: Cancer of Breast

Treatments: Radiation: Hypofractionated WBI; Radiation: Accelerated Partial Breast Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02375048

1288

Details and patient eligibility

About

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Full description

Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Enrollment: 179 patients

Sex: Female

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 55< Age <70
• Tumor size ≤ 2 cm
• pN0 (SN biopsy or ALND)
• ER/PgR positive
• Margins > 5 mm (either at initial surgery or at re-excision)
• Clips placed in the surgical bed (minimum of 4 clips)
• Unicentric only
• No lymphovascular invasion
• Any grade
• No extensive intraductal component (>25%)
• Written informed consent

Exclusion criteria

• Prior thoracic radiation therapy
• Oncoplastic surgery / No clips in the surgical bed
• Multicentric cancer
• Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

179 participants in 2 patient groups

Hypofractionated WBI

Active Comparator group

Description:

Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).

Treatment:

Radiation: Hypofractionated WBI

Accelerated Partial Breast Irradiation

Experimental group

Description:

Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).

Treatment:

Radiation: Accelerated Partial Breast Irradiation