Comparing different radiotherapy methods for early breast cancer after surgery
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
This study is testing different types of radiation therapy for women with early breast cancer after surgery to see which method works best to lower the chance of cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | Female |
| Sponsor | Instituto Brasileiro de Controle do Cancer Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04669873 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 50 years and older with early-stage invasive adenocarcinoma of the breast who have undergone breast-conserving surgery.
Not a fit: Patients with previous malignancies, mastectomy, or specific types of breast cancer such as HER2+ or triple-negative breast cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored radiotherapy options for patients with early breast cancer, potentially improving their survival rates.
How similar studies have performed: Other studies have shown promising results with similar approaches in breast cancer radiotherapy, but this specific comparison in the Brazilian population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- IBCC Oncologia — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Eduardo Barbieri
- Email: edurxt@gmail.com
- Phone: +551198639-1945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.