New approach to partial breast irradiation for breast cancer
Accelerated Partial Irradiation of the Breast: New Altered Fractionation
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT04101656
This study is testing a new way to give radiation treatment for breast cancer that aims to reduce the number of sessions while still being effective for patients who have had surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 174 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (other) |
| Locations | 1 site (Seville) |
| Trial ID | NCT04101656 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a new dose fractionation scheme for Accelerated Partial Breast Irradiation (APBI) using modulated intensity radiotherapy (IMRT) in patients with breast cancer. The focus is on reducing the number of treatment sessions while maintaining effectiveness, thereby potentially improving patient quality of life. The study targets non-metastatic patients who have undergone conservative surgery and aims to assess the impact of this treatment on residual microscopic disease in the surgical bed. By utilizing hypofractionated schemes, the study seeks to enhance treatment efficiency and accessibility.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 and older, or 40-44 without additional risk factors, diagnosed with infiltrating ductal carcinoma or ductal carcinoma in situ who have undergone conservative surgery.
Not a fit: Patients with multicentric or multifocal tumors, BRCA positive mutations, or those who have undergone neoadjuvant chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter treatment times and improved quality of life for breast cancer patients.
How similar studies have performed: Other studies have shown success with similar hypofractionated approaches in breast cancer treatment, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 45 years or 40-44 if there isn´t any other risk factor * Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm. * Disease free margins (R0: \> 2mm). * Positive and negative estrogen receptor tumors. Exclusion Criteria: * Multicentric and multifocal tumors, except from if it´s focal and the only risk factor. * Patients must not have undergone a neoadjuvant QT therapy. * Patients with BRCA positive mutation will be excluded. * Those patients unable or unsuitable to understand and accept the informed consent. * Metastasic´s affectation evidence. * Extensive lymphovascular invasion, except from if the total resulting size of the focus and breast parenchyma addition is ≤ 3cm. * Breast implants presence in the breast that´s going to be treated. * Contraindicated radiotherapy treatment due to a diagnosis of cutaneous lupus, pregnancy or scleroderma. * Inability to fully know the dosimetric data of the APBI plan.
Where this trial is running
Seville
- Hospital Universitario Virgen Macarena — Seville, Spain (RECRUITING)
Study contacts
- Study coordinator: Carlos Míguez Sánchez
- Email: carlos.miguez.sspa@juntadeandalucia.es
- Phone: 955 00 80 00
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.
Conditions: Breast Cancer, Radiotherapy, Accelerated Partial Breast Irradiation, APBI, Modulated Intensity Radiotherapy, IMRT, Positive estrogen receptor