Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
IBCC Oncologia
RECRUITING
São Paulo
Contact Information
Primary
Eduardo Barbieri
edurxt@gmail.com
+551198639-1945
Backup
Alayne D Yamada, PhD
alayne.pesquisa@ibcc-mooca.org.br
+55113474-4242
Time Frame
Start Date: 2021-03-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 36
Treatments
Active_comparator: Active Comparator: Standard
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
Experimental: Experimental 1: Hypofractionated radiotherapy
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
Experimental: Experimental 2: Accelerated Partial Breast Irradiation
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
Related Therapeutic Areas
Sponsors
Leads: Instituto Brasileiro de Controle do Cancer

This content was sourced from clinicaltrials.gov