Phase III Study Comparing Pumitamig Plus Chemotherapy to Placebo Plus Chemotherapy in Patients With Untreated Locally Recurrent or Metastatic Triple-Negative Breast Cancer Not Eligible for PDL1 Therapy

What this Trial Is About

This trial studies adults with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer TNBC who are not eligible for PDL1 therapy based on PD-L1 negative disease. It is a Phase III, randomized, double-blind study comparing pumitamig with chemotherapy versus placebo with chemotherapy. The trial aims to evaluate the effects and safety of pumitamig in combination with chemotherapy for this patient group. Participants are randomly assigned to one of two groups one receives pumitamig plus a chemotherapy regimen chosen by their physician, and the other receives a matching placebo plus chemotherapy. Chemotherapy options include paclitaxelnab-paclitaxel, gemcitabine plus carboplatin, or eribulin, administered per standard care. The treatment period continues until disease progression, intolerable side effects, withdrawal, death, or trial end. After treatment, participants enter a safety follow-up for up to 90 days and a survival follow-up lasting until death, withdrawal, loss of contact, or sponsor decision. During the study, participants undergo screening lasting up to 28 days to confirm eligibility. They receive regular chemotherapy and study drug or placebo infusions during treatment. Researchers assess progression-free survival and overall survival up to about 32 and 49 months respectively. Other outcomes include response rates, quality of life, adverse events, and treatment tolerability. Safety monitoring continues after treatment, and survival is followed long-term. The total study participation can span several years depending on individual outcomes and follow-up.

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