RecruitingOBSERVATIONAL

FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

This study, called FREDO-ODX, is looking at real-world information about women in France with early-stage breast cancer. Specifically, it's for those with a common type of breast cancer that's hormone receptor-positive and HER2-negative. The main goal is to understand how well patients do when their treatment, which usually involves medicines for the whole body (like chemotherapy or hormone therapy), is guided by a special genetic test called Oncotype DX Breast Recurrence Score. This test helps doctors decide if chemotherapy is likely to be helpful or if hormone therapy alone might be enough, aiming to personalise treatment and avoid unnecessary side effects.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

4,500

Start

15 Oct 2023

Estimated completion

01 Mar 2029

Breast Cancer

What is this study about?

This study, known as FREDO-ODX, is all about understanding how a special test called Oncotype DX helps doctors make treatment choices for certain women with early breast cancer. Doctors use this test to look at the genes in a breast cancer tumour. The results from the Oncotype DX test give a number, called a Recurrence Score, which helps predict how likely the cancer is to come back and if chemotherapy would be beneficial.

The main idea of this study is to see how women actually do in their day-to-day lives when their treatment is guided by this test. It focuses on a common type of breast cancer that is Hormone Receptor-positive (HR+) and HER2-negative, meaning the cancer cells respond to hormones but don't have too much of a protein called HER2. By studying many patients, researchers hope to get a clearer picture of the real-world benefits of using this test to decide on treatments, such as chemotherapy or hormone therapy.

The findings from this study are important because they can help doctors and patients make more informed decisions about treatment plans. If the test helps guide effective treatment, it could mean some women avoid strong chemotherapy and its side effects if it's not likely to help them. Ultimately, this research aims to improve care for women with this type of breast cancer by refining how we use genetic information to personalise their journey.

Key takeaways

The study looks at how a genetic test (Oncotype DX) guides breast cancer treatment.
It focuses on a common type of early breast cancer (HR+/HER2-).
The goal is to see how women do in real-life when treatment is chosen with the test.
No new treatments or patient involvement are required beyond existing medical records.
Findings could help doctors make better-informed decisions for future patients.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have been diagnosed with a type of breast cancer that has spread into the surrounding tissue (invasive breast carcinoma). Your cancer specifically needs to be hormone receptor-positive (meaning it grows in response to hormones) and HER2-negative (meaning it doesn't have too much of a particular protein called HER2). Crucially, you would also need to have had the Oncotype DX test done, and your cancer must be operable, meaning it can be removed by surgery.

There are also some reasons why you might not be able to join. For example, if your cancer is too widespread to be operated on, or if you have another type of cancer that was diagnosed in the last 10 years (other than some skin cancers). You also couldn't take part if you have multiple different types of breast cancer at the same time, or if you've already started certain treatments like chemotherapy or hormone therapy before surgery. If the cancer has spread to more than four lymph nodes, or if it has already spread to other parts of your body, you wouldn't be eligible.

Finally, if you've been part of a similar study called RxPONDER in France, or if you've told your doctor you don't want to be in the study, you wouldn't be included. The study is only for women, and you must be able to legally agree 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.

Are you at least 18 years old?
Do you have invasive breast cancer that is HR+ and HER2-?
Have you had the Oncotype DX test?
Was your cancer operable (could it be removed by surgery)?
Was your cancer not metastatic (had it not spread far) at diagnosis?
Have you not had more than 4 lymph nodes involved with cancer?

Answer every question to see your result.

What does participation involve?

This study does not involve new treatments or procedures beyond your standard care. Instead, it looks back at information already collected from your medical records. This means you won't need extra visits, have additional tests, or take different medications specifically for the study. Your doctors will continue to manage your care as they would normally. There's no active follow-up required from you for the study itself; researchers will simply use anonymous information from your past medical records to understand treatment outcomes over time. The total duration of your participation, in terms of data collection, would depend on how long your medical information has been recorded following your diagnosis and treatment.

Potential risks and benefits

Since this study only involves reviewing existing, anonymised medical records, there are no direct physical risks to you. Your personal information will be kept confidential. The potential benefit is that the information gathered from many patients like yourself could help doctors understand more about how the Oncotype DX test helps guide treatment for breast cancer. This knowledge could improve care for future patients. You have the right to withdraw your consent for your anonymised data to be used at any point, without affecting your medical care.

Locations (5)

CHU Besançon
Verified postcode
Besançon, France· Recruiting
Clinique Tivoli Ducos
Verified postcode
Bordeaux, France· Recruiting
Polyclinique Bordeaux Nord Aquitaine
Verified postcode
Bordeaux, France· Recruiting
AP-HP - Hôpital Tenon
Verified postcode
Paris, France· Recruiting
Centre Catalan d'Oncologie
Verified postcode
Perpignan, France· Not yet recruiting

Common questions

What is the Oncotype DX test?

It's a genetic test on your breast cancer tumour that helps predict how likely the cancer is to come back and if chemotherapy would be helpful.

Will I receive new treatment in this study?

No, this study only looks at information from your past medical records and doesn't involve any new treatments or procedures for you.

Is my privacy protected?

Yes, your personal information will be kept confidential, and the data used in the study will be anonymous.

Why is this study being done?

To understand how well the Oncotype DX test helps doctors choose the best treatments for women with early breast cancer in real-life settings.

Who is funding this study?

The information provided does not specify the funding source for this study.

How to find out more

Elise ROBERT

e1robert@chu-besancon.fr +33381219086 Official trial record

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