Registry of Breast Microseed Treatment for Early Stage Breast Cancer
A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer
This study is testing a new way to deliver targeted radiation therapy using tiny radioactive seeds for women with early stage breast cancer after their surgery to see if it helps prevent cancer from coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Concure Oncology-Breast Microseed Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Pittsburgh, Pennsylvania and 2 other locations) |
| Trial ID | NCT02701244 on ClinicalTrials.gov |
What this trial studies
This study focuses on women diagnosed with early stage breast cancer who have undergone lumpectomy. It evaluates the use of Permanent Breast Seed Implant (PBSI) as a targeted radiation therapy, which involves implanting radioactive seeds in the breast to deliver radiation directly to the area most at risk of cancer recurrence. The procedure is performed on an outpatient basis under local anesthesia, allowing patients to maintain a normal lifestyle while receiving treatment. The study aims to ensure proper clinician training and gather data on the safety and effectiveness of PBSI across multiple centers.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with early stage invasive or in-situ ductal carcinoma who have undergone breast conserving surgery.
Not a fit: Patients with previous cancers, active autoimmune disorders, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the side effects of radiation therapy while effectively targeting cancerous areas.
How similar studies have performed: Previous studies on PBSI have shown promising results, but this study aims to expand the evaluation across multiple institutions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological diagnosis of invasive or in-situ ductal carcinoma (DCIS) * Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy * Surgical margins clear for invasive carcinoma (no tumor at ink margin) or superior or equal to 2 mm for in-situ ductal carcinoma (DCIS) * A maximum tumor size of 3 cm * Age ≥50 years old * Informed consent signed if participating in the Registry Exclusion Criteria: * No previous cancer unless in remission for more than 2 years. * Active auto immune disorder with severe vasculitis component * Uncontrolled and complicated insulin-dependent diabetes * Pregnancy * Cosmetic breast implants * Psychiatric or addictive disorder that would preclude attending follow-up * Post-operative breast infection requiring prolonged antibiotic therapy * Lobular features on histology (pure or mixed) or sarcoma histology * Node macroscopically positive on axillary dissection or in the sentinel lymph node biopsy * Extensive in- situ carcinoma * Multicentric disease (in more than one quadrant or separated by 2 cm or more) * Paget's disease of the nipple * Metastases * Patients presenting with a large post-surgical fluid cavity as determined on the planning Ultrasound (US), resistant to the application of hot compresses for 4 weeks * Clear delineation of the target volume on Computerized Tomography (CT) is not possible * Volume to be implanted over 150cc * Target volume too close to skin such that the 90% isodose overlaps the skin surface
Where this trial is running
Pittsburgh, Pennsylvania and 2 other locations
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Mary Washington Hospital — Fredericksburg, Virginia, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Juanita Crook, MD — British Columbia Cancer Agency
- Study coordinator: Juanita Crook, MD
- Email: jcrook@bccancer.bc.ca
- Phone: +1 250 712 3958
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.