Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined with Nab-Paclitaxel Compared with Pembrolizumab Combined with Nab-Paclitaxel in Participants with Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

This study is looking at a new treatment approach for triple-negative breast cancer (TNBC) that has spread or can't be operated on. It compares a new medicine called tobemstomig, given with an existing chemotherapy drug (nab-paclitaxel), against another combination of pembrolizumab (a common immunotherapy drug) with nab-paclitaxel. This is a Phase II study, meaning it's still in the earlier stages of testing to see how well the new treatment works and if it's safe. Researchers want to find out if the new combination can stop the cancer from growing for longer. They will also look at how many people respond to the treatment, how long that response lasts, how long people live, and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

18 Aug 2023

Triple-Negative Breast Cancer (TNBC)

What is this study about?

This research study is about a kind of breast cancer called triple-negative breast cancer (TNBC). This type of cancer is harder to treat because it doesn't respond to the common hormone or anti-HER2 treatments. In this study, we're looking at patients whose TNBC has either spread to other parts of the body (metastatic) or is too advanced to be removed by surgery (locally advanced unresectable). All participants in this study will have cancer cells that show a specific marker called PD-L1.

The main goal of this study is to see if a new combination of medicines works better than a common existing treatment. The new combination being tested involves a drug called tobemstomig given alongside a chemotherapy medicine called nab-paclitaxel. This will be compared to another standard treatment combination: pembrolizumab (which is an immunotherapy drug that helps your body’s immune system fight cancer) also given with nab-paclitaxel.

Researchers will carefully compare these two treatment combinations to understand a few key things. Primarily, they want to know if the new combination can stop the cancer from growing or spreading for a longer period. They will also check how many patients see their cancer shrink or disappear, how long that positive effect lasts, and how long people live overall. Importantly, they will also be closely monitoring any side effects to make sure the treatments are as safe as possible.

Key takeaways

This study is for advanced triple-negative breast cancer that hasn't been treated before.
It's comparing a new drug combination against a common existing one.
The main goal is to see if the new treatment can stop cancer from growing for longer.
Side effects and safety will be closely monitored.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

You must have been diagnosed with triple-negative breast cancer that has spread or cannot be removed with surgery. This means your cancer is considered advanced. Also, your cancer cells must show a specific mark called PD-L1, which doctors will test for.

This study is for people who haven't had any treatment for their advanced triple-negative breast cancer yet. There will be other health checks and requirements too, which your doctor will discuss with 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.

Am I 18 years old or older?
Do I have triple-negative breast cancer that has spread or cannot be removed by surgery?
Has my doctor confirmed my cancer cells have the PD-L1 marker?
Have I not received any treatment for my advanced triple-negative breast cancer yet?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of the two treatment groups at random, like flipping a coin. Neither you nor your doctor will know which treatment you are receiving, which is common in these types of studies to make sure the results are fair.

You will receive your assigned medications according to a set schedule. This will involve regular visits to the hospital or clinic for your treatments and check-ups. During these visits, doctors and nurses will monitor your health closely, including taking blood tests, checking your vital signs (like blood pressure), and performing scans to see how your cancer is responding.

The study will also involve regular follow-up appointments, even after your main treatment period, to keep track of your long-term health and any effects of the treatment. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than existing options, or you might help researchers learn more about triple-negative breast cancer, which could help future patients. However, there's no guarantee the treatment will work for you, and it might not be better than standard care. All medicines can have side effects, and the study treatments may cause unwanted reactions, which will be carefully monitored. You will be told about all known potential side effects. Please remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia
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Unverified
Hungary
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Unverified
Poland
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Unverified
Spain
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Unverified
Germany
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Unverified
Denmark
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Unverified
Netherlands
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Unverified
Italy

Common questions

What is triple-negative breast cancer?

It's a type of breast cancer that doesn't have the three markers (oestrogen receptors, progesterone receptors, and HER2 protein) that doctors usually look for. This means it doesn't respond to hormone therapies or treatments that target HER2.

What does 'Phase II' mean?

Phase II means this is an early stage of testing. Researchers are trying to see if the new treatment works, how safe it is, and what side effects it might have, in a larger group of people than in Phase I studies.

What does 'double-blind' mean?

Double-blind means that neither you nor your doctor will know which specific treatment you are receiving in the study. This helps ensure the results are unbiased and robust.

What is PD-L1?

PD-L1 is a protein that can be found on cancer cells. Its presence can sometimes help doctors decide if certain immunotherapy treatments might be effective.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatments or the extra tests related to the study. This is standard for clinical trials.