RecruitingNAINTERVENTIONAL

Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients

This study focuses on improving how we predict treatment success for early-stage breast cancer patients. Doctors in France estimate nearly 58,500 new cases of breast cancer each year. Significant progress has been made, especially in tailoring treatments based on how a tumour shrinks after initial therapy. However, for some patients, the cancer might not respond as well as hoped, leading to poorer outcomes. This research will collect a wide range of information, including clinical details, lab results, scans, and information about the patient's lifestyle. By combining all this complex data, researchers aim to create a smart tool (an algorithm) that can better predict how each individual's cancer will respond to treatment, helping doctors make more informed decisions.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Cancerologie de l'Ouest

Enrolment target

300

Start

31 Oct 2023

Estimated completion

01 Apr 2033

Breast Cancer

What is this study about?

This research study is all about finding better ways to predict how well treatments will work for people with early-stage breast cancer. Breast cancer is very common, and doctors have made huge progress in the last few years with new medicines and ways to check how well treatments are working. One important way they currently do this is by seeing how much a tumour shrinks after the first treatment, often before surgery. This helps them decide what to do next.

However, sometimes, even with the best current methods, it's hard to know exactly how a patient will respond. For some, the treatment might not be as effective as hoped, and doctors want to improve this. That's why this study aims to gather lots of different types of information about patients and their cancers. This includes things like their medical history, details about their tumour from biopsies and scans, and information from their blood tests. They'll also look at special details from the tumour cells themselves, like their genetic makeup.

By bringing all this complex information together, working with experts in maths and science, the goal is to build a clever computer program. This program would be able to analyse all the data and give doctors a much better idea of how likely a patient's cancer is to respond well to certain treatments. Ultimately, this could lead to more personalised care, where treatments are more precisely chosen for each individual, hopefully leading to better outcomes.

Key takeaways

This study aims to improve prediction of breast cancer treatment success.
It collects various patient data to build a smart prediction tool.
Participation involves biopsies, blood samples, and questionnaires.
It's for adults (18+) with early-stage breast cancer needing chemotherapy before surgery.
Your treatment will follow standard medical guidelines regardless of participation.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have breast cancer that has been confirmed by a doctor, but has not spread to other parts of your body. You should be in good general health and require chemotherapy treatment before any surgery (this is called neoadjuvant chemotherapy).

You would also need to be willing to follow the study plan, including attending appointments and tests. Importantly, you can't be pregnant or breastfeeding, or have certain other serious health conditions that would make taking part unsafe. The study also cannot include someone who has had another type of cancer in the last five years (apart from very minor skin cancers or certain non-invasive cervical cancers).

There are also specific rules for a smaller part of the study focused on returning to work. For this section, you would need to be employed at the time your cancer was diagnosed and currently be on sick leave.

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 18 years old or older?
Do you have confirmed breast cancer that hasn't spread?
Are you having chemotherapy before surgery for your breast cancer?
Are you able to attend study appointments as required?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to sign a consent form. You would have a biopsy (a small sample taken from your breast), give blood samples, and fill out some questionnaires. You'll continue with your planned breast cancer treatment, and during this time, researchers will collect more information about your health, treatment response, and details from your tumour. The study will involve regular visits and examinations as part of your normal care, plus any extra steps needed for the research, like additional blood tests or filling out more questionnaires. The total duration of your participation will depend on your treatment plan and follow-up schedule.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could lead to better prediction of treatment success for future breast cancer patients. While there are no direct guarantees of personal benefit from this specific study, the insights gained could improve care significantly. Risks associated with the study are generally low and mostly linked to standard medical procedures like biopsies and blood draws, which carry small risks of bruising, discomfort, or infection. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Institut de Cancérologie de l'Ouest
Verified postcode
Angers, France· Recruiting
Institut de Cancérologie de l'Ouest
Verified postcode
Saint-Herblain, France· Recruiting

Common questions

What kind of breast cancer is this study for?

This study is for people with early-stage breast cancer that has not spread to other parts of the body.

What does 'neoadjuvant chemotherapy' mean?

It means you're having chemotherapy treatment before surgery to try and shrink the tumour first.

Will taking part change my treatment plan?

No, your doctors will choose your treatment based on standard recommendations, and the study will collect information alongside that.

What information will the study collect about me?

They will collect details about your medical history, biopsy results, scans, blood samples, and your response to treatment.

Is this study only for women?

No, the study is open to both men and women with breast cancer.

How to find out more

Jean Sebastien FRENEL, MD

jean-sebastien.frenel@ico.unicancer.fr +33240679900 Official trial record

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