RecruitingPHASE3INTERVENTIONAL

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

This study is for women with certain types of early breast cancer. Normally, many women with breast cancer receive radiation treatment to the breast or chest and nearby lymph glands (regional radiotherapy) to help prevent the cancer from returning. However, doctors are unsure if all women with a lower risk of their cancer coming back truly need this specific type of radiation. This trial aims to find out if avoiding regional radiotherapy for these women is just as effective as having it. If successful, it could mean women avoid potential side effects from a treatment they might not need, improving their quality of life after breast cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Canadian Cancer Trials Group

Enrolment target

2,140

Start

16 Oct 2018

Estimated completion

30 Dec 2027

Breast Cancer

What is this study about?

This study is focused on improving the treatment for women with certain types of early breast cancer. When you have breast cancer, doctors aim to remove the cancer and then often recommend further treatments like hormone therapy, chemotherapy, and radiation to reduce the chance of it coming back.

One common treatment is 'regional radiotherapy,' which means radiation therapy given to the breast or chest wall and to the lymph glands in the armpit and above the collarbone. While this treatment is very effective for many, researchers believe that some women with a lower risk of their cancer returning might not actually need this specific radiation. This means they could be having a treatment with potential side effects that doesn't actually offer them extra protection.

The main goal of this study is to compare what happens when women with this lower-risk breast cancer receive regional radiotherapy with what happens if they don't. By doing this, doctors hope to learn if it's safe and just as effective to skip regional radiotherapy for these particular patients. If the study shows that skipping this treatment is just as good, it means fewer women would have to go through unnecessary radiation, helping them avoid potential side effects and have a better experience during their recovery.

Key takeaways

This study aims to discover if some women with early breast cancer can avoid a type of radiation.
It could help reduce unnecessary side effects for patients.
You would receive either regional radiation or no regional radiation, decided by chance.
All other standard breast cancer treatments will still be given.
The research helps doctors make better decisions for future breast cancer patients.

Who may be eligible?

This study is for women who have recently been diagnosed with certain types of breast cancer that hasn't spread to other parts of their body. You must have had surgery, either a lumpectomy or a mastectomy, to remove the cancer, and the edges of the removed tissue must be clear of cancer cells.

The cancer itself needs to have specific features. This includes having a certain type of breast cancer (called invasive carcinoma), and it must have a particular 'score' from a test called Oncotype DX (your doctor can explain this). Your cancer also needs to be sensitive to hormones (ER positive) and not have too much of a protein called HER2.

Your doctor will check if your cancer is considered 'low-risk' based on these features and how many lymph nodes were affected. You'll also need to be planning to take hormone therapy for at least five years, and you might or might not have had chemotherapy. If you meet these criteria, you may be able to take part.

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.

I am a woman recently diagnosed with invasive breast cancer that hasn't spread.
I have had surgery (lumpectomy or mastectomy) with clear margins.
My cancer is sensitive to hormones (ER positive) and HER2 negative.
My cancer has a specific 'Oncotype DX' score of 25 or less.
I am planning to take hormone therapy for at least 5 years.
I am willing for my tumour tissue and blood samples to be used for research.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive regional radiation therapy (the usual treatment) or you will not receive regional radiation therapy. The choice of which group you are in is made randomly, like flipping a coin. You will still receive all other necessary treatments, such as hormone therapy.

Throughout the study, you will have regular check-ups and assessments, similar to what you would typically have after breast cancer treatment. Researchers will monitor your health and how well the treatment is working over a period of time. The exact number of visits and the total length of your participation will be explained in detail by the study team.

Potential risks and benefits

Potential benefits of joining this study include the possibility of avoiding regional radiation therapy and its associated side effects if you are in the group that doesn't receive it, while still receiving effective treatment for your cancer. This could improve your quality of life. For future patients, the study will help doctors understand who truly needs this treatment. Potential risks are primarily related to the treatments themselves; if you receive radiation, you may experience side effects like skin changes or tiredness. If you are in the group that doesn't receive radiation, there's a small chance your cancer could return, though the study is designed for patients considered low-risk. You are free to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (485)

Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Banner-University Medical Center Phoenix
Verified postcode
Phoenix, United States· Suspended
University of Arizona Cancer Center-Orange Grove Campus
Verified postcode
Tucson, United States· Recruiting
University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States· Recruiting
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States· Active not recruiting
Kaiser Permanente-Anaheim
Verified postcode
Anaheim, United States· Recruiting
Kaiser Permanente-Bellflower
Verified postcode
Bellflower, United States· Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Verified postcode
Berkeley, United States· Active not recruiting
City of Hope Corona
Verified postcode
Corona, United States· Recruiting
City of Hope Comprehensive Cancer Center
Verified postcode
Duarte, United States· Recruiting
Kaiser Permanente Dublin
Verified postcode
Dublin, United States· Recruiting

Common questions

What is 'regional radiotherapy'?

It's a type of radiation treatment given to the breast/chest area and nearby lymph glands to help prevent breast cancer from coming back.

Why are doctors doing this study?

They want to find out if some women with early-stage, lower-risk breast cancer can safely skip regional radiotherapy to avoid unnecessary side effects.

Will I still get other treatments if I join?

Yes, you will still receive all other recommended treatments like hormone therapy, and potentially chemotherapy if needed.

How will I know if I'm in the radiation or no-radiation group?

Which group you are in is decided randomly, like drawing lots. You won't be able to choose.

What happens if I change my mind about participating?

You are completely free to leave the study at any time, and it won't affect your medical care.

How to find out more

Wendy Parulekar

wparulekar@ctg.queensu.ca 613-533-6430 Official trial record

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