Partial Breast Irradiation for Breast Cancer

(PBSI Trial)

Overseen By Deidre Batchelar, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must be taking: Estrogen receptor modulators

Disqualifiers: Stage T2 cancer, High grade carcinoma, Extensive DCIS, Positive axillary nodes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 0

75 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Stranded Palladium Seed Interstitial Implant for Partial Breast Irradiation for Breast Cancer?

Research shows that palladium-103 seeds, used in prostate cancer treatment, have been adapted for breast cancer with promising results. The seeds are designed to reduce imaging artifacts and improve dose accuracy, making them a good option for breast brachytherapy. ^{1 2 3 4 5}

Is partial breast irradiation using palladium seeds safe for humans?

Research on palladium seeds, often used in prostate cancer treatment, suggests they are generally safe, with reduced imaging artifacts and negligible interseed effects, making them a promising option for breast cancer treatment. ^{1 2 3 6 7}

How is the Stranded Palladium Seed Interstitial Implant treatment different from other breast cancer treatments?

The Stranded Palladium Seed Interstitial Implant is unique because it uses palladium-103 seeds encapsulated in a biocompatible polymer, which reduces imaging artifacts and interseed effects, making it a promising option for breast brachytherapy. This treatment is performed in a single, short procedure under sedation, offering a convenient alternative to traditional radiation therapy. ^{2 3 4 7 8}

What is the purpose of this trial?

Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

Research Team

Juanita Crook, MD

Principal Investigator

British Columbia Cancer Agency

Eligibility Criteria

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.

Inclusion Criteria

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 cancer is low or intermediate grade.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant partial breast radiotherapy using PBSI with 3D ultrasound and CT guidance

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

5 years

Regular visits (frequency not specified)

Treatment Details

Interventions

• Stranded Palladium Seed Interstitial Implant

Trial Overview 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.

Participant Groups

Group I: Breast seed implant Experimental Treatment 3 Interventions

Stranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dosimetric parameters as predictive factors for biochemical control in patients with higher risk prostate cancer treated with Pd-103 and supplemental beam radiation. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

An experimental palladium-103 seed (OptiSeedexp) in a biocompatible polymer without a gold marker: characterization of dosimetric parameters including the interseed effect. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

High dose rate brachytherapy as prostate cancer monotherapy reduces toxicity compared to low dose rate palladium seeds. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

ROPES eye plaque brachytherapy dosimetry for two models of (103)Pd seeds. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Regression Patterns of Iris Melanoma after Palladium-103 (103Pd) Plaque Brachytherapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Some treatment planning considerations for 103Pd and 125I permanent interstitial implants. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. [2022]