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Search / Trial NCT04669873

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

Launched by INSTITUTO BRASILEIRO DE CONTROLE DO CANCER · Dec 9, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Radiotherapy Hypofractionated Breast Conserving Surgery

ClinConnect Summary

This clinical trial is investigating two different types of radiation therapy for women with early-stage breast cancer who have had surgery to remove the tumor while preserving the breast. The goal is to determine which treatment works better at reducing the chances of the cancer coming back. One method being studied is called Accelerated Partial Breast Irradiation, which targets only the part of the breast where the tumor was located, while the other method is the standard whole-breast radiation that treats the entire breast area.

To participate in this trial, women must be at least 50 years old and have undergone breast-conserving surgery for a specific type of early-stage breast cancer. They should have a tumor size smaller than 3 cm and no signs of cancer spread to the lymph nodes. Participants will receive information about the study and must give their consent before joining. This is an exciting opportunity for eligible women, as it will help provide valuable information on the best radiation treatment options available for breast cancer patients in Brazil.

Gender

FEMALE

Eligibility criteria

  • 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

About Instituto Brasileiro De Controle Do Cancer

The Instituto Brasileiro de Controle do Câncer (IBCC) is a leading Brazilian institution dedicated to cancer research, treatment, and prevention. With a focus on advancing oncological care, IBCC conducts innovative clinical trials aimed at improving patient outcomes and understanding cancer biology. The institute collaborates with a network of healthcare professionals and researchers to provide state-of-the-art facilities and expertise, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its commitment to scientific excellence and patient-centered care, IBCC aims to contribute significantly to the global fight against cancer.

Locations

Sao Paulo, Sp, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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