RecruitingOBSERVATIONAL

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

This study aims to find out if certain women with a very early type of breast cancer, called Ductal Carcinoma in Situ (DCIS), can safely avoid radiotherapy after having surgery to remove the cancer. DCIS means there are abnormal cells in the milk ducts, but they haven't spread. Researchers will use details about the cancer and a special genetic test (Oncotype DX DCIS score) to identify women who have a very low chance of the cancer returning in the same breast. If these women can avoid radiotherapy, it could mean fewer side effects and less hospital visits, while still getting excellent care. This could help doctors make more personalised treatment plans.

At a glance

Status

Recruiting

Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrolment target

526

Start

23 Nov 2022

Estimated completion

30 Nov 2035

DCIS

What is this study about?

This research study is looking into a particular type of very early breast cancer called Ductal Carcinoma in Situ, or DCIS. With DCIS, abnormal cells are found within the milk ducts of the breast, but they haven't spread into the surrounding breast tissue or other parts of the body. Treatment for DCIS often involves surgery to remove the affected area, sometimes followed by radiotherapy to help reduce the chance of the cancer coming back in the same breast. However, some women might have such a low risk of recurrence that they don't actually need radiotherapy.

Researchers want to see if they can accurately identify these women. They plan to combine standard information about the cancer (like its size and how fully it was removed) with results from a special genetic test called the Oncotype DX DCIS score. This test looks at genes within the cancer cells to predict how likely the DCIS is to return. The goal is to find a group of women who have a very low risk of the DCIS coming back after surgery, meaning they might be able to safely skip radiotherapy. This could spare them from potential side effects and extra hospital visits.

By carefully following these women over time, the study hopes to show that avoiding radiotherapy is a safe and effective option for some. This would be a significant step towards offering more tailored treatments for DCIS, ensuring that women receive the care they need without unnecessary interventions.

Key takeaways

The study explores if some women with early breast cancer (DCIS) can skip radiotherapy.
It uses a genetic test (Oncotype DX DCIS score) to identify very low-risk cases.
Participation involves sharing medical details and annual check-ups for 10 years.
Potential benefit: avoiding radiotherapy side effects.
Your health records and test results will be carefully monitored.
This research aims to offer more personalised DCIS treatment.

Who may be eligible?

To join this study, you would generally need to be a woman over 45 years old who has been diagnosed with DCIS without any signs of it spreading. The DCIS would need to be relatively small, no bigger than 2.5cm, and have been completely removed during surgery with clear edges of tissue. After surgery, a special genetic test (Oncotype DX DCIS score) would need to show that you have a very low chance (10% or less over 10 years) of the DCIS coming back.

There are also some reasons why you wouldn't be able to join. For example, if your DCIS appeared in multiple places in the breast, or if you've ever had any type of invasive breast cancer or other breast cancer in the same breast. If you've had a serious illness within the last five years (other than non-melanoma skin cancer), or if your general health isn't good enough for you to be followed for 10 years, you wouldn't be able to take part. Also, if getting to follow-up appointments would be very difficult due to where you live, that would exclude 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.

Are you a woman over 45?
Do you have DCIS without any sign of it spreading?
Was your DCIS completely removed by surgery and was it 2.5cm or smaller?
Have you had the Oncotype DX DCIS test, showing a very low risk of recurrence?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is that your doctor or a member of their team will explain everything in detail and seek your agreement to participate. You would then be registered for the study. The actual involvement includes collecting information about your general health, the details of your surgery, and the characteristics of your DCIS. Your stored tissue sample from your surgery will be sent for the special Oncotype DX DCIS genetic test.

The results of this test will be shared with your doctor. After this, you would be followed up by the study team every year for a total of 10 years. These annual follow-up appointments would involve having a breast examination and mammograms on both breasts to check for any changes. All of your information will be carefully recorded and checked throughout the study. The total duration of your active participation, including follow-up, is 10 years.

Potential risks and benefits

A potential benefit of taking part in this study is that if you meet the specific criteria, you might be able to avoid radiotherapy, which would mean fewer hospital visits and fewer potential side effects associated with radiation. You would also be contributing to important research that could help women with DCIS in the future. As with any study, there could be some risks, such as the inconvenience of extra appointments or the possibility that the DCIS could still return, although the study is designed to select women at very low risk. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (24)

Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting
Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting
BC Cancer - Abbotsford Centre
Verified postcode
Abbotsford British Columbia, Canada· Recruiting
BC Cancer - Centre for the North (Prince George)
Verified postcode
Prince George, Canada· Recruiting
BC Cancer - Fraser Valley Centre
Verified postcode
Surrey, Canada· Recruiting
BC Cancer - Vancouver Centre
Verified postcode
Vancouver, Canada· Recruiting
BC Cancer - Victoria
Verified postcode
Victoria, Canada· Recruiting
QE II HSC - Nova Scotia Cancer Centre
Verified postcode
Halifax, Canada· Recruiting
Cape Breton Cancer Centre
Verified postcode
Sydney, Canada· Recruiting
Royal Victoria Regional Health Centre
Verified postcode
Barrie, Canada· Recruiting
Juravinski Cancer Centre
Verified postcode
Hamilton, Canada· Recruiting
London Regional Cancer Program
Verified postcode
London, Canada· Recruiting

Common questions

What is DCIS?

DCIS (Ductal Carcinoma in Situ) is a very early form of breast cancer where abnormal cells are found in the milk ducts but have not spread outside them.

What is the Oncotype DX DCIS score?

It's a special genetic test on your DCIS tissue that helps predict how likely the DCIS is to come back in the same breast after surgery.

Why might I avoid radiotherapy?

If your DCIS is low-risk, based on its characteristics and the genetic test, the study is exploring if radiotherapy might not be necessary for you to achieve excellent outcomes.

How long will I be followed up if I join?

You will have yearly check-ups, including breast exams and mammograms, for 10 years.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can withdraw at any point without it affecting your medical care.

How to find out more

Adrianne Van Dam

avandam@mcmaster.ca 905-527-2299 Official trial record

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