Pumitamig with Chemotherapy for Triple-Negative Breast Cancer

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

Recruiting Phase 3 Interventional Study
Breast Neoplasms
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
558 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for

This trial is looking for patients with specific types of breast cancer who cannot use certain immune therapies. Participants will receive either the study drug or a placebo along with chemotherapy.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with triple-negative breast cancer.
  • I have a measurable tumor.
  • I have provided a tissue sample for testing.
  • I have an ECOG performance status of 0 or 1.

You may not be able to join if

  • I have had previous treatment for advanced cancer.
  • I have received certain immunotherapy treatments before.
  • I took high-dose steroids recently.
  • I have been vaccinated with live vaccines in the last month.
  • I received antibiotics within the last two weeks.
  • I am pregnant, breastfeeding, or planning to become pregnant.
  • I had major surgery or significant trauma in the last 28 days.
  • I have undergone an organ transplant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherap…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 estrogen receptor (ER)-low, human epidermal…
Contacts

BioNTech clinical trials patient information

+49 6131 9084

patients@biontech.de

CONTACT