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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 202 → 212 locations
  2. Trial sites expanded: 181 → 202 locations Interventions: Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Matching placebo (Drug), Nab-paclitaxel/Paclitaxel (Drug), Pumitamig (Drug) to Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Matching placebo (Drug), Nab-paclitaxel/Paclitaxel (Drug), Pumitamig (Drug) · Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 4 of 15 entries · 1 more Show 4 more changesShow less
    • Interventions: Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Matching placebo (Drug), Nab-paclitaxel/Paclitaxel (Drug), Pumitamig (Drug) to Carboplatin (Drug), Eribulin (Drug), Gemcitabine (Drug), Matching placebo (Drug), Nab-paclitaxel/Paclitaxel (Drug), Pumitamig (Drug)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 15 entries
    • Study description expanded, about 7 words
  3. Trial sites expanded: 161 → 181 locationsv12
  4. Trial sites expanded: 155 → 161 locationsv11
  5. Trial sites expanded: 143 → 155 locationsv10
  6. Trial sites expanded: 104 → 143 locationsv9
  7. Trial sites expanded: 83 → 104 locationsv8
  8. Trial sites expanded: 63 → 83 locationsv7
  9. Trial sites expanded: 28 → 63 locationsv6
  10. Study sites: 14 to 28v5
  11. Study sites: 8 to 14v4
  12. Study sites: 1 to 8v3
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2025 to Oct 30, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2025 to Oct 30, 2025
  14. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BioNTech SE
49 trials monitored
See 3 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
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.
Trial Details
NCT Number NCT07173751
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Breast Neoplasms
Enrollment 558 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov