Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy (HYPHEN)

Instituto Brasileiro de Controle do Cancer

Status: Enrolling

Conditions: Malignant Breast Neoplasm

Treatments: Radiation: Ultra-hypofractionated whole breast radiotherapy; Radiation: Standard Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05665920

60905722.0.0000.0072

Details and patient eligibility

About

The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

Full description

This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Information to the patient and signed informed consent;
• Women aged ≥18 years;
• Breast conserving surgery;
• Invasive adenocarcinoma (except classic invasive lobular carcinoma);
• TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
• Eastern Cooperative Oncology Group (ECOG) 0 -1;
• Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
• No previous breast or mediastinal radiotherapy;
• No hematogenous metastases;
• Ability to carry out long-term follow-up;

Exclusion criteria

• Previous local irradiation;
• Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
• Histology of metaplastic carcinoma;
• History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
• Diagnosis of autoimmune and connective tissue diseases;
• Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
• Indication of internal breast irradiation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Standard Whole breast Radiotherapy

Active Comparator group

Description:

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Treatment:

Radiation: Standard Radiation

Ultra-hypofractionated whole breast radiotherapy

Experimental group

Description:

Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Treatment:

Radiation: Ultra-hypofractionated whole breast radiotherapy