Active not recruitingNAINTERVENTIONAL

Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

This research study is for women aged 65 or older with a specific type of early-stage breast cancer. The study is investigating a new treatment approach where a single dose of radiation therapy is given to the breast tumour three months before surgery. The aim is to see if this delayed timing and single radiation dose can effectively treat small, low-risk breast cancers. This is different from standard treatments, which often involve radiation after surgery or multiple doses. By exploring this, doctors hope to find a gentler and more convenient treatment option for eligible patients, potentially reducing the overall treatment burden while maintaining good outcomes.

At a glance

Status

Active not recruiting

Phase

Sponsor

Michael Yassa

Enrolment target

Start

01 Apr 2018

Estimated completion

31 Dec 2025

Breast Cancer

What is this study about?

This study is looking into a new way to treat certain types of early breast cancer in women aged 65 and above. Currently, after breast cancer surgery, some women might need a course of radiation therapy over several weeks to help stop the cancer from coming back. This study is exploring a different approach.

Researchers want to see if giving a single dose of radiation therapy directly to the breast tumour *before* surgery, and then waiting three months for the surgery, is a good option. This treatment is only for specific, small, low-risk tumours. The idea is that this single, targeted radiation dose might effectively treat the cancer and allow patients to have surgery later, making the overall treatment process potentially simpler and more convenient.

By testing this, doctors are hoping to find a treatment that is just as effective as current methods, but with fewer overall hospital visits and a quicker radiation treatment time for certain patients. This research could help improve how we treat breast cancer in the future, especially for older women with suitable tumours.

Key takeaways

Targets early, low-risk breast cancer in women 65+.
Tests a single radiation dose before surgery.
Surgery happens 3 months after radiation.
Aims for a simpler radiation treatment routine.
Not suitable for all breast cancer types.

Who may be eligible?

This study is for women aged 65 or older with a specific type of early breast cancer. You would need to have had a recent biopsy confirming a common type of breast cancer called invasive ductal carcinoma, which should also be shown to have certain characteristics — specifically, it needs to be 'oestrogen receptor positive' and 'HER2 negative', and a lower grade (grade 1 or 2). Your tumour should be small, less than 2cm, and there should be no sign of cancer spread to your lymph nodes.

You would not be able to join if you are under 65, have certain genetic changes like BRCA mutations, or have a larger tumour or cancer affecting your lymph nodes. Other reasons for not being able to join include having very specific types of breast cancer, cancer that has spread to other areas, or if you've already had certain treatments like chemotherapy or hormone therapy before surgery. Your overall health and other medical conditions would also be considered.

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 aged 65 or older?
Do you have a small breast tumour (under 2cm)?
Has your biopsy shown 'invasive ductal carcinoma', that is 'oestrogen receptor positive', 'HER2 negative', and Grade 1 or 2?
Is there no sign of cancer in your lymph nodes?
Have you *not* had chemotherapy or hormone treatment for this breast cancer already?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first receive a single dose of radiation therapy targeting your breast tumour. After this, there would be a waiting period of three months before your planned surgery, which would be a partial mastectomy (removing part of the breast) and a check of the lymph nodes under your arm. Throughout this time, and potentially for some time after the surgery, you would have regular appointments with the study team. These appointments would involve physical examinations, scans, and possibly blood tests to monitor your health and how the treatment is working. The exact number and timing of visits would be explained fully by the study team.

Potential risks and benefits

Potential benefits of taking part could include receiving a single dose of radiation treatment, which might be more convenient than multiple doses, and contributing to new knowledge that could help future patients. However, like all medical treatments, there are potential risks, side effects, or discomfort from the radiation therapy or surgery. The doctors will fully explain all known risks. Your participation is always voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Maisonneuve-Rosemont Hospital
Verified postcode
Montreal, Canada

Common questions

What is 'single pre-operative radiation therapy'?

It means you receive just one dose of radiation to your breast tumour *before* your surgery, rather than many doses after surgery.

Why is there a three-month delay until surgery?

The study wants to see how effective that single radiation dose is in treating the cancer during this time before the surgery takes place.

Is this suitable for all types of breast cancer?

No, it's only for specific small, early-stage breast cancers with certain features in women aged 65 and over.

What kind of surgery will I have?

The planned surgery is a partial mastectomy, which means removing part of the breast, along with checking the lymph nodes under your arm.

Will I still need other treatments later?

The study is testing this specific approach. Your doctors will discuss any further treatments based on your individual case and the study findings.