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

Conditions

• Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pumitamig — DRUG
  Solution for intravenous (IV) infusion
• Nab-paclitaxel/Paclitaxel — DRUG
  IV infusion
• Gemcitabine — DRUG
  IV infusion
• Carboplatin — DRUG
  IV infusion
• Eribulin — DRUG
  IV infusion
• Matching placebo — DRUG
  IV infusion

Study Details

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 chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.

Key Dates

Start date

Oct 30, 2025

Status verified

May 2026

Primary completion

Dec 31, 2029

Completion

Sep 30, 2030

Study Design

Enrollment

558 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy
  Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.
• Placebo Comparator: Arm 2: Placebo + TPC Chemotherapy
  Participants will be administered with matching placebo plus chemotherapy regimen.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 32 months ]

Central Contacts

• BioNTech clinical trials patient information
  +49 6131 9084
  [email protected]

Locations (26)

Find similar trials in Springdale, AR

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