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

Instituto Brasileiro de Controle do Cancer36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Neoplasm of Breast

Interventions

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of local recurrence

To estimate and compare the rate of local recurrence between the experimental and control arms.

Time frame: 5 years

Secondary Outcomes

Time to occurrence of distant metastases

Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.

Time frame: 5 years

Disease-free survival

Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Time frame: 5 years

Overall survival

Overall survival time, defined as number of days from randomization until death or end of follow-up.

Time frame: 5 years

Medico-economic study

To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation