RecruitingPHASE3INTERVENTIONAL

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

This is a Phase 3 study for people with an advanced type of breast cancer called triple-negative breast cancer. Researchers want to see how safe and effective a new drug, Pumitamig, is when given alongside standard chemotherapy, compared to a dummy pill (placebo) with standard chemotherapy. Participants will be randomly put into one of two groups and neither they nor their doctors will know which treatment they are receiving. The study involves checks before treatment, receiving the treatment until it's no longer helping or causes bad side effects, and then follow-up appointments to monitor health and progress. The aim is to find better ways to treat this type of breast cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BioNTech SE

Enrolment target

558

Start

30 Oct 2025

Estimated completion

01 Sep 2030

Breast Neoplasms

What is this study about?

This research study, called ROSETTA Breast-01, is exploring a new treatment for a specific type of breast cancer known as triple-negative breast cancer. This cancer can be difficult to treat, so doctors are always looking for better options. The study is particularly interested in a drug called Pumitamig.

In this study, participants will be split into two groups by chance – like flipping a coin. One group will receive Pumitamig alongside their usual chemotherapy, while the other group will receive a 'placebo' (a dummy drug that looks just like Pumitamig but contains no active medicine) alongside their chemotherapy. Neither you nor your study doctor will know which treatment you are getting. This helps make sure the study results are fair and accurate.

The main goal of this study is to find out if adding Pumitamig to standard chemotherapy is safe and works better than chemotherapy alone for people with this type of breast cancer. This is a "Phase 3" trial, which means it's one of the final steps before a new treatment might become available to more people if it proves to be safe and effective.

Key takeaways

Exploring a new drug (Pumitamig) for advanced triple-negative breast cancer.
Compares Pumitamig + chemotherapy versus placebo + chemotherapy.
Participants are assigned treatments by chance, and neither they nor doctors know which.
Study involves initial checks, treatment, and long-term health monitoring.
Aim is to find a safer and more effective treatment option.
You can leave the study at any time.

Who may be eligible?

This study might be suitable for you if you have advanced triple-negative breast cancer that has come back locally or spread to other parts of your body. You should have had your cancer diagnosis confirmed recently and have at least one part of your cancer that can be measured.

There are also specific requirements about previous treatments. For example, if you've already had certain types of anti-cancer treatments for advanced disease or some specific modern immunotherapy drugs, you might not be able to join. Also, if you're taking high doses of steroids, you might need to stop them before starting the trial, with a few exceptions.

To make sure the study is right for you and that your participation is safe, the medical team will check details about your specific cancer, your overall health, and any other medications you are taking.

Quick self-check

Do I have advanced triple-negative breast cancer that has come back or spread?
Has my doctor confirmed that standard immunotherapy for my cancer is not suitable for me?
Do I have at least one measurable area of cancer?
Am I generally well enough to participate in a clinical trial (ECOG score 0 or 1)?
Have I received certain previous cancer treatments that might exclude me (e.g., specific immunotherapies)?
Am I able to provide a tissue sample for analysis?

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

What does participation involve?

If you join this study, your journey will have a few stages. First, there's a 'screening period' that could last up to 28 days. During this time, the study team will do tests and check your medical history to make sure the study is right for you. They'll also need a sample of your cancer tissue, either from a past biopsy or a new one if necessary.

Once you're cleared for the study, you'll enter the 'treatment period'. You'll receive either Pumitamig or the placebo, combined with chemotherapy chosen by your doctor. You'll continue with this treatment for as long as it's helping and not causing severe side effects, or until a major event like your disease getting worse or the study ending. After your treatment finishes, there will be follow-up appointments. For up to 90 days, the team will check on your safety. Then, there will be a longer-term follow-up to monitor your health and how you're doing, which will continue until certain conditions are met, such as the end of the study.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new drug (Pumitamig) that isn't yet widely available, and close medical monitoring. However, there are also potential risks; the new drug might cause side effects, some of which could be serious or unexpected. The treatment might also not work as well as hoped. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (104)

Highlands Oncology Group
Springdale, United States· Recruiting
University Of California - San Diego Moores Cancer Center
La Jolla, United States· Recruiting
Cedar Sinai - Samuel Oschin Cancer Center
Los Angeles, United States· Recruiting
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, United States· Recruiting
Sacred Heart Medical Oncology Group
Pensacola, United States· Recruiting
Cancer Care Specialists
Decatur, United States· Recruiting
Cancer Care Specialists of Illinois
O'Fallon, United States· Recruiting
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, United States· Recruiting
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, United States· Recruiting
New England Cancer Specialists
Westbrook, United States· Recruiting
Saint Agnes Hospital, Clinical Research Center
Baltimore, United States· Recruiting
Lahey Hospital & Medical Center
Burlington, United States· Recruiting

+92 more sites — see the official record for the full list.

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer where the cancer cells don't have certain 'receptors' that are targeted by some other common breast cancer drugs. This means it needs different treatment approaches.

What does 'randomised 1:1' mean?

It means you have an equal 50/50 chance of being placed into either the group receiving Pumitamig or the group receiving the placebo.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects accurately.

Will I know if I'm getting the study drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is over.

How long will I be in the study?

The screening period is up to 28 days. Treatment continues as long as it's beneficial. After treatment, there's a safety follow-up for up to 90 days, followed by a longer-term survival follow-up.

How to find out more

BioNTech clinical trials patient information

patients@biontech.de +49 6131 9084 Official trial record

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