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

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

Detailed Description
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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.

Official Title
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Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)

Conditions
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Cancer of Breast

Intervention / Treatment
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* Radiation: Hypofractionated WBI
* Radiation: Accelerated Partial Breast Irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 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: Hypofractionated WBI<br>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). | Radiation: Hypofractionated WBI<br>* 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.<br>|
| Experimental: Accelerated Partial Breast Irradiation<br>Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA). | Radiation: Accelerated Partial Breast Irradiation<br>* APBI 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity will be measured with CTCAE v.4.0 |  | ten years | 
| Cosmesis will be measured with Harvard scale |  | ten years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Local Control |  | ten years | 
| Disease Free Survival |  | ten years | 
| Overall Survival |  | ten years | 
| Quality of Life Questionnaire |  | ten years |