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

Instituto Brasileiro de Controle do Cancer

Status: Enrolling

Conditions: Malignant Neoplasm of Breast

Treatments: Radiation: Experimental 1: Hypofractionated radiotherapy; Radiation: Experimental 2: Accelerated Partial Breast Irradiation; Radiation: Active Comparator: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT04669873

38341220.8.0000.0072

Details and patient eligibility

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Active Comparator: Standard

Active Comparator group

Description:

Whole breast Radiotherapy, 40 Gray (40Gy) fractions

Treatment:

Radiation: Active Comparator: Standard

Experimental 1: Hypofractionated radiotherapy

Experimental group

Description:

Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions

Treatment:

Radiation: Experimental 1: Hypofractionated radiotherapy

Experimental 2: Accelerated Partial Breast Irradiation

Experimental group

Description:

Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.

Treatment:

Radiation: Experimental 2: Accelerated Partial Breast Irradiation