Oncoplastic partial mastectomy with intraoperative radiation therapy for early stage breast cancer patients with prior chest wall radiation
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
This study is testing if using a special type of radiation during surgery can help women with early-stage breast cancer who have had previous chest wall radiation, by looking at how well it works and how it affects their recovery and appearance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Saint John's Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT05289466 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of intraoperative radiation therapy (IORT) during oncoplastic partial mastectomy in patients with early-stage breast cancer who have previously undergone chest wall radiation. It aims to assess the cosmetic outcomes and perioperative complications associated with this approach. Additionally, the study will measure the effectiveness of the procedure by monitoring local, regional, and distant recurrence rates, as well as overall survival and disease-specific survival. The study is non-randomized and single-arm, focusing on a specific patient population with unique treatment histories.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with a history of breast cancer who have refused standard mastectomy and meet specific eligibility criteria.
Not a fit: Patients with multifocal disease, nodal involvement, or those requiring mastectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cosmetic outcomes and reduce recurrence rates for patients with a history of chest wall radiation.
How similar studies have performed: While the use of IORT in breast cancer treatment has been explored, this specific application in patients with prior chest wall radiation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 50 y.o. * Histologically proven in situ and invasive ductal or lobular breast recurrence * Prior history of whole breast/chest wall radiation therapy * Disease span ≤ 3 cm, unifocal * No nodal disease (N0) * No evidence of metastatic disease (M0) * Time from initial BCT should be ≥ 1 year * Patients have refused the standard of care of mastectomy * Skin distance of ≥ 0.8 cm between applicator and skin Exclusion Criteria: * Multifocal and/or multicenter recurrence * N1-3 status: Regional cytological or histologically proven node recurrence * M1 status: Metastatic disease * cT4 (Skin or muscle involvement) or Paget's disease of the nipple * Patients undergoing mastectomy * Patients undergoing neoadjuvant systemic therapy * Connective tissue disease or scleroderma, contraindicating radiotherapy
Where this trial is running
Santa Monica, California
- Providence Saint John's Hospital — Santa Monica, California, United States (Recruiting)
Study contacts
- Principal investigator: Janie L Weng Grumley, MD — Saint John's Cancer Institute
- Study coordinator: Janie Weng Grumley, MD
- Email: janie.grumley@providence.org
- Phone: (310)-582-7100
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.