Preoperative radiotherapy for early stage breast cancer
Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
This study is testing if a single dose of targeted radiation before surgery can safely help patients with early-stage breast cancer by shrinking their tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 79 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT04679454 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility, safety, and efficacy of a single fraction of preoperative ablative radiotherapy for patients with early-stage breast cancer. It consists of two main sections: a technical study focusing on the setup and dosimetric aspects of the CyberKnife system, and a clinical study that includes a phase I dose escalation to determine the maximum tolerated dose and a phase II study to assess the rate of pathological complete response. Patients will undergo surgical tumor removal 4-8 weeks after the radioablation treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically proven unifocal adenocarcinoma of the breast, T1-T2 tumors up to 2.5 cm, and good general health.
Not a fit: Patients with tumors close to the skin or chest wall, pure non-invasive tumors, or those who have received prior radiation therapy or neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes by enhancing the rate of complete pathological response in early-stage breast cancer patients.
How similar studies have performed: Other studies have explored preoperative radiotherapy, but this specific approach using a single fraction and the CyberKnife system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven unifocal adenocarcinoma * T1-T2 * Tumor size up to 2.5 cm * cN0 * Age ≥ 18 years old * Good general condition (ECOG 0-2) * Planned BCS * Written informed consent Exclusion Criteria: * Tumor close to skin or chest wall * Pure non-invasive tumor * Prior RT to the chest * Neoadjuvant chemotherapy * Collagenopathies * Coagulation or autoimmunitary disorders * Previous malignancies
Where this trial is running
Milan
- IEO, European Institute of Oncology IRCCS — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Cristina Leonardi — European Institute of Oncology
- Study coordinator: Maria Cristina Leonardi, MD
- Email: cristina.leonardi@ieo.it
- Phone: +39 02 57489037
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.