Stereotactic body radiation therapy for advanced breast cancer
A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)
This study is testing whether a special type of radiation therapy can help patients with advanced breast cancer who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Toronto Sunnybrook Regional Cancer Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03585621 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of stereotactic body radiotherapy (SBRT) as a primary treatment for patients with unresectable breast cancer. It aims to enroll 24 patients who are not candidates for surgery due to metastatic disease or other medical reasons. Participants will receive SBRT in four fractions over a period of 12-15 days. The study is designed to assess the safety and efficacy of this treatment approach in managing advanced breast cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed invasive breast carcinoma who are not eligible for surgery due to various medical conditions.
Not a fit: Patients with multifocal or multicentric tumors or significant nodal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for patients with advanced breast cancer, potentially improving their outcomes.
How similar studies have performed: Other studies have shown promising results with SBRT for various cancers, indicating potential success for this approach in breast cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology. Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment. Primary breast and axillary surgery not recommended/performed due to any of the following: * distant metastatic disease * unresectable T4 disease and/or * medically inoperable and/or * patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent. Exclusion Criteria: Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease \>= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy \> 50% of the ipsilateral whole breast volume. Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
Where this trial is running
Toronto, Ontario
- Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Danny Vesprini, MD, FRCPC — Sunnybrook Health Sciences Centre, University of Toronto
- Study coordinator: Danny Vesprini, MD, FRCPC
- Email: Danny.Vesprini@sunnybrook.ca
- Phone: 4164804806
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.