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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    36
  • sponsor
    Instituto Brasileiro de Controle do Cancer
Updated on 18 March 2021

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.

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 the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Details
Condition Breast Cancer, Breast Cancer, cancer, breast
Treatment Active Comparator: Standard, Experimental 1: Hypofractionated radiotherapy, Experimental 2: Accelerated Partial Breast Irradiation
Clinical Study IdentifierNCT04669873
SponsorInstituto Brasileiro de Controle do Cancer
Last Modified on18 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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