Comparing two types of radiotherapy for breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IBCC Oncologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Eduardo Barbieri — IBCC Oncologia
• Study coordinator: Eduardo Barbieri
• Email: edurxt@gmail.com
• Phone: +551198639-1945

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.