Cancer of Breast Clinical Trial
Official title:
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
Verified date | October 2018 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
Status | Terminated |
Enrollment | 179 |
Est. completion date | February 1, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Clinico Humanitas | Rozzano | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity will be measured with CTCAE v.4.0 | ten years | ||
Primary | Cosmesis will be measured with Harvard scale | ten years | ||
Secondary | Rate of Local Control | ten years | ||
Secondary | Disease Free Survival | ten years | ||
Secondary | Overall Survival | ten years | ||
Secondary | Quality of Life Questionnaire | ten years |
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