Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer

This study, called WIN-B, is for people in the UK and other countries who have advanced triple-negative breast cancer (TNBC) or a type called hormone-receptor-positive/HER2-negative (HR+/HER2-) breast cancer. Researchers are testing a new combination of two medicines, Debio0123 and Sacituzumab govitecan. The main goals are to find a safe dose of Debio0123 to use with Sacituzumab govitecan and to see how well this combination works for patients whose cancer has come back or spread after previous treatments. The study has two parts: an early phase (Phase 1) focused on safety and finding the right dose, and a later phase (Phase 2) to further check how effective the treatment is at that dose.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

MedSIR

Enrolment target

Start

17 Jan 2025

Estimated completion

01 Oct 2027

Advanced Breast Cancer

What is this study about?

This study is looking at a new treatment approach for two specific types of advanced breast cancer: triple-negative breast cancer (TNBC) and hormone-receptor-positive/HER2-negative (HR+/HER2-) breast cancer. These are cancers that have come back or spread after initial treatments. Researchers want to see if combining two drugs, Debio0123 and Sacituzumab govitecan, can be a safe and effective way to treat these conditions.

The study is being run in different hospitals across the world. It's designed in two main steps. The first step, called Phase 1, is about figuring out the safest dose of Debio0123 to use when combined with Sacituzumab govitecan. They will gradually increase the dose of Debio0123 to find the best balance between safety and how well it works. Once that best dose is found, the second step, Phase 2, will involve more patients to gather more information on how effective this combination treatment is at slowing or stopping the cancer.

The hope is that this new combination treatment could offer another option for people living with these types of advanced breast cancer, especially those who have already tried other treatments. The study will carefully monitor patients to understand both the benefits and any side effects of the drugs.

Key takeaways

New combination drug trial for advanced breast cancer.
Specifically for TNBC or HR+/HER2- breast cancer that has progressed.
Aims to find a safe dose and test effectiveness.
For patients who have had limited prior treatments for advanced disease.
Participation involves receiving study drugs and regular monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with advanced breast cancer that is either triple-negative (TNBC) or hormone-receptor-positive/HER2-negative (HR+/HER2-). Your doctor will need to confirm the exact type of breast cancer you have.

Your cancer must have returned or spread and cannot be removed by surgery. You also need to have already had at least one, but no more than two, previous chemotherapy treatments for your advanced cancer. If you have HR+/HER2- breast cancer, you must also have tried at least one hormone treatment and have seen your cancer progress while or soon after taking a type of drug called CDK4/6 inhibitors.

You should be well enough to take part and understand what the study involves, and you'll need to give your written permission to join. The medical team will check all your details to make sure this study is the right fit for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced triple-negative breast cancer (TNBC) or HR+/HER2- breast cancer that has spread?
Have you had at least one, but no more than two, previous chemotherapy treatments for your advanced cancer?
If you have HR+/HER2- breast cancer, have you also tried hormone treatment and experienced cancer progression on or after CDK4/6 inhibitors?
Are you able to understand the study and willing to give your written consent?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll receive the study drugs, Debio0123 and Sacituzumab govitecan, as a combination treatment. In the first part of the study, a smaller number of patients (12-24) will help find the right dose of Debio0123. Once that dose is found, more patients (around 52) will receive the combined treatment at this specific dose. You will continue with the treatment until your cancer progresses, you choose to stop, or the study ends. The medical team will regularly check how you are doing, including monitoring your health and checking your cancer with scans like CT or MRI.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could help your cancer, especially if other treatments haven't worked well. However, like all medicines, the study drugs might cause side effects. The researchers will closely monitor you to manage any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitario Clínico San Cecilio de Granada
Granada, Spain
Hospital Beata María Ana
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Beatson West of Scotland Cancer Center
Glasgow, United Kingdom
Barts Health NHS Trust
London, United Kingdom

Common questions

What types of breast cancer is this study for?

This study is for advanced triple-negative breast cancer (TNBC) or hormone-receptor-positive/HER2-negative (HR+/HER2-) breast cancer that has spread or come back.

What medicines are being tested?

The study is testing a new combination of two drugs called Debio0123 and Sacituzumab govitecan.

How long would I need to be in the study?

You would continue treatment until your cancer progresses, you decide to stop, or the study is finished.

What is the main goal of the study?

The study aims to find a safe and effective dose of the drug combination and see how well it works for patients.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your usual medical care.