Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

Recruiting now · Not applicable

Conditions studied: Malignant Neoplasm of Breast

In brief

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.

Key facts

Study ID

NCT04669873

Run by

Instituto Brasileiro de Controle do Cancer

People needed

36

Starts

2021-03-04

Expected to finish

2026-12-31

Last updated by the study team

2021-03-08

Who can join

Age: 50 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IBCC Oncologia — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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