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Brachytherapy
Partial Breast Irradiation for Breast Cancer (PBSI Trial)
N/A
Waitlist Available
Led By Juanita Crook, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 55 years and postmenopausal
Histology must be either Ductal Carcinoma In Situ or invasive ductal adenocarcinoma of the breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
PBSI Trial Summary
This trial is investigating a new form of breast cancer radiation treatment that is less toxic and more affordable than current methods.
Who is the study for?
This trial is for postmenopausal women over 55 with early-stage breast cancer (Stage 0 or I, tumor <2cm) that's been surgically removed with clear margins. Participants must have a life expectancy of at least ten years and cannot have had certain other cancers unless disease-free for five years. Those with genetic mutations in BRCA, high-grade tumors, unclear surgical sites, or previous chest radiotherapy are excluded.Check my eligibility
What is being tested?
The study tests a type of partial breast radiation therapy using Palladium-103 seed implants after lumpectomy in patients with specific types of breast cancer. It aims to refine the technique and gather data on its side effects and costs compared to other treatments.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from similar radiation therapies may include skin changes like redness or irritation at the treatment site, fatigue, discomfort or pain around the implant area, and potential short-term swelling.
PBSI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 55 years old and have gone through menopause.
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My breast cancer is either DCIS or invasive ductal adenocarcinoma.
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My lumpectomy cavity is less than 3 cm across and can be seen clearly on scans.
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My cancer is low or intermediate grade.
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My tumor is positive for estrogen receptors.
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My tumor was completely removed with surgery and the edges were cancer-free.
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My doctor agrees I can have a specific breast cancer treatment involving seed implants.
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My condition involves only one area or organ.
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My breast cancer is in the early stages and the tumor is smaller than 2 cm.
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I had a procedure to check lymph nodes in my armpit for breast cancer.
PBSI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Implant quality
Secondary outcome measures
Cosmesis
Cost
Dose to Organs at risk
+4 morePBSI Trial Design
1Treatment groups
Experimental Treatment
Group I: Breast seed implantExperimental Treatment3 Interventions
Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,436 Total Patients Enrolled
18 Trials studying Breast Cancer
7,986 Patients Enrolled for Breast Cancer
Juanita Crook, MDPrincipal InvestigatorBritish Columbia Cancer Agency
4 Previous Clinical Trials
878 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is extensive DCIS (a type of breast cancer).My cancer has spread to my lymph nodes or blood vessels.I have cancer in both breasts at the same time.My breast cancer is high grade and aggressive.I have been diagnosed with multi-centric breast cancer.My breast cancer is either DCIS or invasive ductal adenocarcinoma.My lumpectomy cavity is less than 3 cm across and can be seen clearly on scans.My surgery did not remove all of my cancer, or it's unclear if it did.I have a BRCA 1 or 2 gene mutation.My cancer is low or intermediate grade.I had or will have brachytherapy within 4 months after my last breast surgery.I have been cancer-free for 5 years, except for certain skin cancers or early-stage cervical or colon cancer.My tumor is positive for estrogen receptors.I am over 55 years old and have gone through menopause.It's not possible to clearly see the area where the surgery was done.I have suspicious lymph nodes that haven't been confirmed negative by a biopsy.I have Paget's disease of the nipple.I have ongoing major issues after surgery.You have breast implants.I have suspicious breast changes not confirmed as benign.I have had radiation therapy on the same side of my chest or breast before.My tumor was completely removed with surgery and the edges were cancer-free.My doctor agrees I can have a specific breast cancer treatment involving seed implants.You have cancer in the lymph nodes in your armpit.My breast cancer is at stage T2 or more advanced.My condition involves only one area or organ.I have a collagen vascular disease.My breast cancer is in the early stages and the tumor is smaller than 2 cm.I had a procedure to check lymph nodes in my armpit for breast cancer.You are expected to live for at least ten more years.I have had breast cancer or DCIS in the same breast before.
Research Study Groups:
This trial has the following groups:- Group 1: Breast seed implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research accept individuals aged 40 or over as participants?
"This clinical trial is only open to applicants between the ages of 55 and 80. Conversely, there are 64 separate trials for individuals under 18 years old and 2208 tests available for those over 65 years old."
Answered by AI
Would I be eligible to join this clinical investigation?
"Qualified participants for this medical trial must between the ages of 55 and 80, with a diagnosis of breast cancer. Currently, 75 potential patients are being sought out."
Answered by AI
What is the current availability of patient slots in this research project?
"The clinical trial as listed on clinicaltrials.gov is not currently recruiting patients, despite having been initially published in February 2015 and updated in March 2022. Nevertheless, over 2290 other studies are actively seeking out participants at this time."
Answered by AI
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