Status:
UNKNOWN
Pilot Study of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant to Treat Breast Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
BC Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 60 years
Phase:
NA
Brief Summary
Background: Recent single arm studies have suggested that partial breast irradiation (PBI), delivered in a relatively short overall treatment time of a few days, may be an effective alternative to adj...
Eligibility Criteria
Inclusion
- Female subject with a pathologically-confirmed diagnosis of invasive ductal carcinoma.
- Tumor size \< 2cm.
- Negative axillary node involvement, determined by either
- Sentinel node biopsy,
- Axillary node dissection removing \> 6 nodes
- No evidence of metastatic disease.
- Treated by BCS with microscopically clear resection margins (\> 2mm to ink) for invasive and non-invasive disease or no residual disease on re-excision.
Exclusion
- Age \< 60 years.
- Subjects who will receive adjuvant chemotherapy.
- A known deleterious mutation in BRCA-1 and/or BRCA-2.
- Extensive DCIS, mammographically or pathologically.
- Tumor histology of pure lobular carcinoma (invasive or in-situ).
- Adenoid cystic and non-epithelial malignancies (e.g. sarcoma or lymphoma).
- Lymphovascular invasion (LVI) present.
- Bilateral invasive malignancy of the breast (synchronous or metachronous).
- More than one ipsilateral breast primary tumor.
- Previous irradiation to the ipsilateral breast.
- Presence of an ipsilateral breast implant.
- Serious non-malignant disease that precludes radiation treatment or conscious sedation.
- Unable for any reason to undergo PBSI within 14 weeks of the last breast surgery.
- Concomitant malignancies, except non-melanoma skin cancer and carcinoma in situ of any site.
- Significant persistent post-surgical complications.
- Currently pregnant or lactating.
- Psychiatric or addictive disorders which would preclude obtaining informed consent.
- Subject not committed to at least 3 years of follow-up.
- Low CBC levels: HB \< 100 - Platelets \< 100 - Neutrophil count \< 1
- Close partner not consenting
- Inability to confidently localize/delineate the surgical cavity on CT and/or US.
- Subject not suitable for a minimum 2-plane implant based on tumor location/breast size.
- Seroma exceeding 3cm
- Seroma within the inner quadrants
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01191164
Start Date
September 1 2011
End Date
September 1 2016
Last Update
August 25 2011
Active Locations (1)
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1
British Columbia Cancer Agency
Victoria, British Columbia, Canada, V8R 6V5