Not yet recruitingNAINTERVENTIONAL

SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors

This study is investigating a new way to treat breast cancer that has spread to other parts of the body, or is locally advanced. It uses a very focused type of radiation called Stereotactic Ablative Radiotherapy (SABR). The main goal is to see how well SABR controls the cancer in the breast and the nearby areas. Doctors will also track how long people live, how long they stay free of the cancer growing again, and when they might need different treatments. They'll also carefully watch for any side effects from the radiation, especially skin irritation, swelling, and nerve problems. Finally, they'll look at blood tests to see if they can predict how people will respond to treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

British Columbia Cancer Agency

Enrolment target

Start

01 Jul 2025

Estimated completion

30 Jul 2030

Breast Cancer Metastases

What is this study about?

This study is for people with breast cancer that has spread, either nearby or to other parts of the body. Doctors are investigating a special type of radiation treatment called Stereotactic Ablative Radiotherapy, often shortened to SABR. This isn't the usual, everyday radiation treatment; it's a very precise method that delivers high doses of radiation to a small area, aiming to destroy cancer cells while causing less harm to healthy tissues.

The main aim of this study is to find out if SABR can effectively control the cancer in the breast and the areas immediately around it. This is really important because controlling the cancer in these primary sites can help improve a person's quality of life. The research team will also be looking at several other important things, including how long people live after treatment, how long they can go without the cancer growing or spreading further, and if SABR affects when they might need other treatments. They will also carefully monitor and record any side effects from this specialised radiation, such as skin reactions, swelling in the arm (lymphoedema), or nerve issues.

Finally, the study has an exploratory aim. Doctors want to collect blood samples from participants to look for tiny markers in the blood. They hope these markers, called biomarkers and circulating tumour DNA, might help them understand why some people respond well to SABR and why others don’t. This could potentially help predict in the future which patients might benefit most from this type of treatment.

Key takeaways

This study uses a special, precise radiation called SABR for breast cancer that has spread.
It aims to see how well SABR controls cancer in the breast and surrounding areas.
Doctors will closely monitor any side effects from the radiation.
Blood samples will be taken to help predict future treatment responses.
Participation involves receiving SABR and attending regular follow-up appointments.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you would need to have breast cancer that has been confirmed by a doctor and is considered Stage IV. This means the cancer has spread beyond the original site.

You also need to have cancer in your breast that can be targeted with radiation therapy. You should be receiving, or planning to receive, other standard cancer treatments, but certain types of chemotherapy or specific targeted drugs would need to be paused during the SABR treatment. You must be over 18 years old, generally well enough to take part in the study, and expected to live for at least another six months. You should also be able to understand the study information and agree to take part, as well as be able to fill out questionnaires.

However, you would not be able to join if you have certain medical conditions that make radiation unsafe for you, such as lupus or a history of lung scarring (IPF). Also, if you’ve had radiation treatment to the same breast before, you wouldn't be able to participate. This study is designed for specific situations, so the doctors will check all these points carefully to see if it's right for you.

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.

Do I have Stage IV breast cancer confirmed by my doctor?
Do I have cancer in my breast suitable for radiation?
Am I over 18 years old?
Am I generally well enough to participate (ECOG 0-2)?
Have I not had previous radiation to the same breast?
Do I have any medical conditions that would make radiation unsafe for me?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the special radiation treatment called SABR. The number of radiation sessions will be decided by the study doctors. During the study, you would have regular appointments to check on your health and how the treatment is working. This will likely involve follow-up scans and physical examinations to assess the cancer and monitor for any side effects. You will also be asked to complete questionnaires about your health and how you are feeling. Throughout the study, small blood samples would be taken to look at specific markers. The total length of your participation would depend on your individual situation, but follow-up will continue for several years to track long-term outcomes and side effects.

Potential risks and benefits

Participating in this study might offer the potential benefit of better control over your breast cancer in the treated area, possibly improving your quality of life. However, as with any medical treatment, there are potential risks, including side effects from the radiation such as skin irritation, swelling, or nerve issues. The study team will monitor you closely for any adverse effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

BC Cancer - Vancouver
Verified postcode
Vancouver, Canada

Common questions

What is SABR?

SABR stands for Stereotactic Ablative Radiotherapy. It's a very precise type of radiation treatment that delivers high doses to a small area to destroy cancer cells.

Will I still receive my other cancer treatments?

You will generally continue with your other cancer treatments, but certain types of chemotherapy or targeted drugs might need to be paused during the SABR treatment period.

What kind of side effects might I experience?

Doctors will be carefully looking for side effects like skin redness or irritation (dermatitis), swelling in the arm (lymphoedema), and nerve-related issues in the arm or shoulder.

What are 'blood biomarkers'?

Blood biomarkers are tiny markers found in your blood that can give doctors clues about your cancer and how it might respond to treatment.

How long will I be in the study?

The study involves regular check-ups and monitoring over several years to understand the long-term effects of SABR, but the main treatment phase is much shorter.

How to find out more

Sandy Chang

sandy.chang@bccancer.bc.ca 6048776000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.