Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
Instituto Brasileiro de Controle do Cancer
36 participants
Mar 4, 2021
INTERVENTIONAL
Conditions
Summary
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer. There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
Eligibility
Inclusion Criteria13
- Information to the patient and signed informed consent;
- Women aged ≥50 years
- Breast conserving surgery
- Pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component)
- Invasive adenocarcinoma (except classic invasive lobular carcinoma)
- Unifocal disease
- Histopathologic grades I or II
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Lymphovascular invasion absent
- Negative axillary lymph nodes
- Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
- No prior breast or mediastinal radiotherapy
- No hematogenous metastases
Exclusion Criteria9
- Previous malignancy (except non-melanomatous skin cancer)
- Mastectomy
- Classical-Type Invasive Lobular Carcinoma
- Neoadjuvant chemotherapy
- Human Epidermal growth factor Receptor-type 2 positive (HER2+)
- Triple-negative breast cancers
- Intravascular lymphoma present
- Contraindications to radiotherapy.
- No geographical, social or psychologic reasons that would prevent study follow
Interventions
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
Locations(1)
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NCT04669873