Active not recruitingNAINTERVENTIONAL

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

This study is investigating a type of radiation treatment called Permanent Breast Seed Implant (PBSI) for women with early-stage breast cancer. PBSI involves placing tiny radioactive seeds directly into the breast after surgery to target the cancer area. We want to see how well this technique works, if it's safe and comfortable for patients, and how it compares in cost to other radiation methods. The study will also help doctors improve how they perform the procedure, especially for different breast sizes and tumour locations. We hope this research will lead to better and more personalised treatment options for women with breast cancer.

At a glance

Status

Active not recruiting

Phase

Sponsor

British Columbia Cancer Agency

Enrolment target

Start

01 Feb 2015

Estimated completion

01 Feb 2026

Early Stage Breast Cancer

What is this study about?

This study is exploring a specific type of radiation therapy for early-stage breast cancer called Permanent Breast Seed Implant (PBSI). After a lumpectomy (surgery to remove the cancerous lump), some women need radiation to reduce the chance of the cancer coming back. Instead of traditional radiation that treats the whole breast over several weeks, PBSI delivers radiation directly to the area where the lump was, using tiny radioactive seeds implanted into the breast tissue. This is a shorter, more focused treatment.

The main goal of this study is to understand how well this seed implant technique works and how safe and comfortable it is for patients. We want to make sure the radiation is delivered precisely where it's needed. We are also looking at ways to improve the procedure, such as using advanced ultrasound technology during the implant, and understanding how it can best be used for different breast shapes and sizes. This helps create a clearer guide for doctors to use this treatment in the future.

Another important aspect of this research is to compare PBSI with other types of breast radiation. We will be looking at how patients feel about the treatment, their quality of life, and the cosmetic results. We will also be tracking any side effects and comparing the costs for both patients and the healthcare system. By carefully studying these aspects, we hope to show if PBSI is a beneficial option for suitable patients, potentially leading to more convenient and effective care.

Key takeaways

Investigating a focused radiation treatment using tiny seeds for early breast cancer.
Aims to improve treatment precision and patient comfort.
Compares this method to other radiation treatments, including costs.
Study involves women aged over 55 with specific early-stage breast cancer.
Looking at long-term results over five years.

Who may be eligible?

This study is looking for women over the age of 55 who have gone through menopause and have a life expectancy of at least ten years. To be considered, you must have very early-stage breast cancer (Stage 0 or I), with the tumour being smaller than 2cm and of a specific mild or moderate type (grade 1 or 2). You must have had the cancer completely removed by surgery (lumpectomy) with clear edges, meaning no cancer cells were left behind at the margins.

The cancer should be limited to one spot in the breast and must be Estrogen Receptor positive. Your doctor will need to confirm that the area where the lump was removed (called the lumpectomy cavity) is clearly visible on scans and is smaller than roughly 3cm. There are also specific requirements about having your lymph nodes checked and some timelines related to when your surgery happened.

You would not be able to join this study if your cancer is more advanced (Stage T2 or higher), if cancer has spread to your lymph nodes, or if your cancer is a more aggressive type (grade 3). Other reasons you might not be eligible include if you have widespread Ductal Carcinoma In Situ (DCIS), if there's evidence of cancer in your blood vessels, or if you have serious surgery complications or other suspicious areas in your lymph nodes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman over 55 and postmenopausal?
Do you have Stage 0 or I breast cancer, with the tumour smaller than 2cm and Grade 1 or 2?
Has your cancer been completely removed by lumpectomy with clear margins?
Is your breast cancer Estrogen Receptor positive?
Are you free of more advanced breast cancer or problematic previous cancers?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the Permanent Breast Seed Implant (PBSI) procedure. This involves a doctor using an advanced ultrasound, and potentially CT scans, to guide tiny radioactive seeds into the area of your breast where the cancer was removed. You will then be carefully followed by the study team for five years after the implant. During this time, you will have regular check-ups and assessments. These visits will help us understand how you are recovering, check for any side effects, assess the cosmetic appearance of your breast, and ask about your general quality of life. We will also be gathering information on the costs involved with this treatment compared to other radiation methods.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a focused radiation treatment directly to the area where your cancer was, potentially reducing the time and travel associated with traditional whole-breast radiation. We hope to confirm that this treatment is safe and effective, and to improve the methods for future patients. As with any medical procedure, there are potential risks, such as side effects from radiation or issues related to the implant procedure, which your doctor will discuss fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

BCCA Center for the Southern Interior
Verified postcode
Kelowna, Canada

Common questions

What are 'radioactive seeds'?

These are tiny, rice-grain-sized implants containing a low dose of radiation that are placed directly into the breast to target cancer cells locally.

Is this a new treatment?

The general idea of seed implants isn't new, but this study focuses on refining the technique for breast cancer, improving its precision, and understanding its long-term effects and costs.

How long will I be in the study?

You will be followed by the study team for five years after receiving the seed implant to monitor your health and the treatment's effectiveness.

Will I become radioactive to others?

The radiation from the seeds is very localised. Your medical team will provide specific advice, but generally, the risk to others is very low, and you can carry on with normal daily activities.

What does 'early-stage breast cancer' mean here?

It means your cancer is very small (less than 2cm), hasn't spread to your lymph nodes, and is of a specific mild or moderate type (grade 1 or 2).