Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
FEMALE
NCT04669873

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

Led by Instituto Brasileiro de Controle do Cancer · Updated on 2021-03-08

36

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 60 years or older
  • Breast conserving surgery performed
  • Pathologic tumor size less than 3 cm
  • Diagnosed with invasive adenocarcinoma (excluding classic invasive lobular carcinoma)
  • Unifocal breast cancer
  • Histopathologic grade I or II
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No lymphovascular invasion
  • Negative axillary lymph nodes
  • Minimum microscopic margins of 2 mm of non-cancerous tissue (excluding deep margin when in deep fascia)
  • No prior breast or mediastinal radiotherapy
  • No evidence of blood-borne metastases
  • Informed consent signed and patient informed
Not Eligible

You will not qualify if you...

  • Previous malignancy except non-melanomatous skin cancer
  • History of mastectomy
  • Classic-type invasive lobular carcinoma
  • Received neoadjuvant chemotherapy
  • Positive for Human Epidermal growth factor Receptor 2 (HER2+)
  • Triple-negative breast cancers
  • Presence of intravascular lymphoma
  • Any contraindications to radiotherapy
  • Geographic, social, or psychological reasons preventing study follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IBCC Oncologia

São Paulo, São Paulo, Brazil, 03102-002

Actively Recruiting

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Research Team

E

Eduardo Barbieri

CONTACT

A

Alayne D Yamada, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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