Comparing two types of radiotherapy for breast cancer treatment

Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

This study is testing if a new type of radiotherapy can safely treat breast cancer just as well as the standard method while reducing the number of hospital visits for women undergoing treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Instituto Brasileiro de Controle do Cancer (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT05665920 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of ultra-hypofractionated radiotherapy compared to standard moderate hypofractionated radiotherapy in women with breast cancer receiving regional nodal radiation. It is a prospective, interventional, exploratory, controlled, randomized study conducted at a single center, aiming to minimize hospital visits while maintaining treatment effectiveness. Participants will receive a total dose of 26 Gy delivered in 5 fractions over one week, with careful monitoring of acute and late toxicity. The study is designed to provide insights into optimizing radiotherapy regimens for better patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with invasive adenocarcinoma of the breast who have undergone breast-conserving surgery and meet specific TNM staging criteria.

Not a fit: Patients with previous breast or mediastinal radiotherapy or those undergoing concomitant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more efficient breast cancer treatment with fewer hospital visits and reduced side effects.

How similar studies have performed: Previous studies have shown promising results with hypofractionated radiotherapy approaches, indicating potential for success in this novel application.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• IBCC Oncologia — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Eduardo Barbieri — IBCC Oncologia
• Study coordinator: Eduardo Barbieri

Conditions Malignant Breast Neoplasm; Dose splitting; Acute and late toxicity; Locoregional drainage irradiation; Breast neoplasm; Overall survival; Disease-free survival; Locoregional control