Comparing different radiotherapy methods for early breast cancer after surgery

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 effectiveness of accelerated partial breast irradiation compared to standard and hypofractionated whole-breast irradiation in women with early-stage breast cancer who have undergone breast-conserving surgery. It is a prospective, randomized pilot study designed to provide comparative data on these radiotherapy regimens specifically for the Brazilian population. The study aims to determine the best treatment approach to reduce the risk of cancer recurrence and improve patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• IBCC Oncologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• 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.