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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for breast cancer using small radioactive seeds, known as the Stranded Palladium Seed Interstitial Implant. The researchers aim to determine if this method, which targets a smaller breast area, is as effective as other radiation therapies while monitoring side effects and costs. It is designed for women over 55 who are postmenopausal and have early-stage breast cancer (tumor smaller than 2 cm) that has been surgically removed. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future breast cancer treatments.

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 prior data suggests that this protocol is safe for partial breast radiotherapy?

Research has shown that the Permanent Breast Seed Implant (PBSI) is a safe method for partial breast radiotherapy. In one study, more than half of the patients reported no pain during the procedure. Long-term data over five years also indicate that PBSI remains a safe option after surgery to remove a breast tumor. This treatment uses tiny radioactive seeds to target the tumor area and is generally well-tolerated by most patients. While some side effects may occur, they are usually mild and manageable. Overall, PBSI appears to be a promising and safe option for treating breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The treatment, a stranded palladium seed interstitial implant, is unique because it targets breast cancer using a precise radioactive seed implant method. Unlike traditional whole-breast radiation therapy, which can affect a larger area, this technique focuses on delivering radiation directly to the tumor site and its margins. This targeted approach, guided by 3D ultrasound and CT, minimizes damage to surrounding healthy tissue and can potentially reduce treatment time. Researchers are excited because this method could offer a more localized and efficient treatment option with fewer side effects for patients.

What evidence suggests that this protocol is effective for breast cancer?

Research has shown that palladium-103 seeds, initially used for prostate cancer, have been adapted for breast cancer with promising results. In previous studies, these seeds were used for partial breast irradiation, effectively targeting cancer cells in the breast. Participants in this trial will receive a stranded palladium seed interstitial implant as part of the breast seed implant treatment arm. The procedure is generally well tolerated, with many patients experiencing minimal discomfort. Five-year data indicates that this method of breast irradiation is a safe and effective option after a lumpectomy, which is surgery to remove a lump from the breast. This approach offers focused treatment, potentially reducing side effects compared to treating the whole breast. ^{1 2 3 4 6}

Who Is on the Research Team?

Juanita Crook, MD

Principal Investigator

British Columbia Cancer Agency

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-breast-neoplasms-1-2015-1e145

Partial Breast Irradiation for Breast Cancer (PBSI Trial) Research shows that palladium-103 seeds, used in prostate cancer treatment, have been adapted for breast cancer with promising results. The seeds are designed ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301605011624

First report of a permanent breast 103Pd seed implant as ... The procedure was well tolerated; 56% of the patients reported no pain during the procedure, and 46% of the patients developed National Cancer Institute Common ...

3. redjournal.org redjournal.org/article/S0360-3016(04)01575-5/pdf

2106 Pilot Studies of Partial Breast Irradiation Using a ... Published data suggests that in selected women, partial breast irradiation with High Dose Rate (HDR) brachytherapy delivered over one week may be as effective ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26461003/

Report on the Clinical Outcomes of Permanent Breast ... The 5-year data suggest that permanent breast seed implantation is a safe accelerated partial breast irradiation option after lumpectomy for ...

5. clinicaltrial.be clinicaltrial.be/en/details/11499?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Partial Breast Irradiation Using Interstitial Permanent P... Breast seed implant must be considered technically deliverable by interstitial brachytherapy by the attending radiation oncologist and must be a ...

6. link.springer.com link.springer.com/chapter/10.1007/978-3-540-88006-6_15

Permanent Breast Seed Implants The chapter describes the PBSI technique and reports outcomes in terms of local control and side effects in a prospective cohort of 67 patients treated between ...