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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

Must not have

Extensive DCIS

Lymphatic or Vascular Invasion positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is extensive DCIS (a type of breast cancer).

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My cancer has spread to my lymph nodes or blood vessels.

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I have cancer in both breasts at the same time.

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My breast cancer is high grade and aggressive.

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I have been diagnosed with multi-centric breast cancer.

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My surgery did not remove all of my cancer, or it's unclear if it did.

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I have a BRCA 1 or 2 gene mutation.

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I have suspicious lymph nodes that haven't been confirmed negative by a biopsy.

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I have Paget's disease of the nipple.

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I have ongoing major issues after surgery.

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I have suspicious breast changes not confirmed as benign.

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I have had radiation therapy on the same side of my chest or breast before.

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My breast cancer is at stage T2 or more advanced.

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I have a collagen vascular disease.

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I have had breast cancer or DCIS in the same breast before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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

Acute and Late Toxicity of breast brachytherapy

Cosmesis

Cost

+4 more

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

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,412 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

Stranded Palladium Seed Interstitial Implant (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02297672 — N/A

Breast Cancer Research Study Groups: Breast seed implant

Breast Cancer Clinical Trial 2023: Stranded Palladium Seed Interstitial Implant Highlights & Side Effects. Trial Name: NCT02297672 — N/A

Stranded Palladium Seed Interstitial Implant (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02297672 — N/A

~7 spots leftby Jul 2025

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