A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
50 Years
N/A
Female
Breast Neoplasms
Trial Information
A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
For early stage breast cancer, accelerated partial breast irradiation is an alternative
treatment option to whole breast irradiation after breast conserving surgery. Our group has
previously reported results of a Phase I/II study of permanent breast seed implant (PBSI)
using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected
breast cancer patients. The procedure is realised in a single session under light sedation
and local freezing. After a median FU of 54 months no patients has recurred on a cohort of
67 patients, and acute of delayed side effect compared favourably to external beam
radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating
appropriately the risk of serious adverse events (SAE). The current study propose evaluating
SAE on a multicentre and larger cohort of 420 patients.
Inclusion Criteria:
- A confirmed histological diagnosis of invasive breast carcinoma
- Treated by breast conserving surgery with axillary node dissection (with a minimum of
6 nodes sampled) or sentinel lymph node biopsy
- Surgical margins clear over or equal to 2 mm
- A maximum tumor size of 3 cm
- Age >= 50 years old
- ECOG performance status of 0 or 1
- Informed consent signed
Exclusion Criteria:
- Previous history of cancer other than curable skin SCC or Tis or T1 cervix
- Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
- Autoimmune disorder
- Diabetes insulin-dependant
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Post-operative breast infection
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy
proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node 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 a post-surgical fluid cavity ≥ 2.5 cm in diameter in any
dimension as determined on the planning US
- Clear delineation of the target volume on CT is not possible
- Having a volume to be implanted over 120cc
- Having a target volume too close to skin such that the 85% isodose overlaps the skin
surface)
- Having a target volume too close to the chest wall, such that there is a risk of
perforating the chest wall
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Serious Adverse Events
Outcome Description:
Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
Outcome Time Frame:
Initial and then yearly up to 5 years
Safety Issue:
Yes
Principal Investigator
Jean-Philippe Pignol, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Sunnybrook Health Sciences Centre
Authority:
Canada: Health Canada
Study ID:
PBSI Registry
NCT ID:
NCT01106521
Start Date:
March 2009
Completion Date:
March 2024
Related Keywords:
- Breast Neoplasms
- Infiltrating ductal carcinoma
- Brachytherapy
- Breast Neoplasms
- Neoplasms
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