Status:
RECRUITING
Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Lead Sponsor:
Instituto Brasileiro de Controle do Cancer
Conditions:
Malignant Neoplasm of Breast
Eligibility:
FEMALE
50-90 years
Phase:
NA
Brief 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 brea...
Detailed Description
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04669873
Start Date
March 4 2021
End Date
December 31 2026
Last Update
March 8 2021
Active Locations (1)
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1
IBCC Oncologia
São Paulo, São Paulo, Brazil, 03102-002