Authorised Therapeutic confirmatory (Phase III) First line triple-negative breast cancer (TNBC)

ROSETTA Breast-01: The effects and safety of pumitamig in patients with triple-negative breast cancer

EU CTIS ID: 2025-521884-12-00

What this study is testing

To compare overall survival (OS) in patients treated with pumitamig in combination with chemotherapy versus placebo plus chemotherapy in the intent-to-treat (ITT) set. To compare progression-free survival (PFS) in patients treated with pumitamig in combination with chemotherapy versus placebo plus chemotherapy as assessed by blinded independent central review (BICR) in the ITT set.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Adults, of 18 years of age or older at the time of giving informed consent. Local laws will be followed if the age of consent is older.
Are men who are sterile or if they are potentially fertile and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their sexual partners to practice a highly effective form of contraception during the trial, starting from the time of giving informed consent and continuously until 6 months after receiving the last dose of pumitamig or placebo.
Agree not to donate and/or cryopreserve germ cells (sperm, oocytes, ova) for the purposes of assisted reproduction during trial, from signing the informed consent form and continuously until 6 months after the last dose of pumitamig or placebo.
Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.
Are willing and able to comply with scheduled visits, the treatment schedule, the planned trial assessments (including patient completed diaries) and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.
Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.

You likely can't join if

Have received any of the following therapies or drugs prior to the initiation of trial: • prior systemic anticancer therapy for advanced disease. • prior treatment with a PD(L)-1/VEGF bispecific antibody. • systemic corticosteroids within 7 days prior to the initiation of trial treatment. • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment. • Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
Have a history of hepatitis B requiring active antiviral therapy.
Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial.
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

See the full eligibility criteria

Who can join

Adults, of 18 years of age or older at the time of giving informed consent. Local laws will be followed if the age of consent is older.
Are men who are sterile or if they are potentially fertile and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their sexual partners to practice a highly effective form of contraception during the trial, starting from the time of giving informed consent and continuously until 6 months after receiving the last dose of pumitamig or placebo.
Agree not to donate and/or cryopreserve germ cells (sperm, oocytes, ova) for the purposes of assisted reproduction during trial, from signing the informed consent form and continuously until 6 months after the last dose of pumitamig or placebo.
Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.
Are willing and able to comply with scheduled visits, the treatment schedule, the planned trial assessments (including patient completed diaries) and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.
Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
Have confirmed locally recurrent inoperable or metastatic TNBC, or ER-low, HER2-negative breast cancer documented prior to trial screening as part of standard of care and whose disease status aligns the detailed description in the protocol.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
Have provided a tissue sample, archival or fresh, during the screening period.
ECOG performance status (PS) of 0 or 1.
Have adequate organ function in regards to haematology, liver function, kidney function, and coagulation.
Are people of child-bearing potential (POCBP) who have a negative serum beta hCG pregnancy test within 7 days of the start of trial treatment.
Are POCBP who agree to practice a highly effective form of contraception and to require their male sexual partners to use barrier contraception methods (preferably condoms), starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of pumitamig or placebo.

What rules you out

Have received any of the following therapies or drugs prior to the initiation of trial: • prior systemic anticancer therapy for advanced disease. • prior treatment with a PD(L)-1/VEGF bispecific antibody. • systemic corticosteroids within 7 days prior to the initiation of trial treatment. • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment. • Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
Have a history of hepatitis B requiring active antiviral therapy.
Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial.
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
Have spinal cord compression or central nervous system metastases that are untreated and symptomatic or require treatment with corticosteroids or anticonvulsants for associated-symptom control.
Have active autoimmune disease that has required systemic treatment in the past 2 years
Have had other malignant tumors within 2 years prior to the trial treatment.
Have any heart conditions within 6 months prior to the trial treatment as described in the study protocol.
Have an active hepatitis C virus infection.
Have hypertension or diabetic conditions prior to initiation of trial treatment as defined in the study protocol.
Are a vulnerable individual, i.e., an individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Have superior vena cava syndrome or symptoms of spinal cord compression.
Have active, or a history of, pneumonitis requiring treatment with steroids, or active, or a history of, interstitial lung disease.
Have a history of tuberculosis that was not successfully treated.
Have serious non-healing wounds, ulcers, or bone fractures.
Have evidence of major coagulation disorders or other significant risks of hemorrhage as defined in the study protocol.
Receive therapeutic anticoagulation or antiplatelet therapy.
Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
Have a history of serious Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy or have AEs from prior antitumor therapy that have not returned to Grade 1
Have a known or suspected hypersensitivity to the trial treatments including any active ingredient or excipients thereof.
Have a known history of human immunodeficiency virus with CD4+ T˗cell counts below 350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.

The study team makes the final eligibility decision.

Where it's taking place

Argentina
China
Korea, Republic of
Brazil
Japan
Canada
Singapore
Australia
United Kingdom
Turkey
United States
Mexico

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; China; Korea, Republic of; Brazil; Japan; Canada and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.