Print this page

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination with Chemotherapy versus Placebo with Chemotherapy in Patients with Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease.

Primary Objectives:
- To compare OS in patients treated with pumitamig in combination with chemotherapy versus placebo plus chemotherapy in the ITT set.

- To compare PFS in patients treated with pumitamig in combination with chemotherapy versus placebo plus chemotherapy as assessed by BICR in the ITT set.

Secondary Objectives:
- To compare ORR in patients treated with pumitamig in combination with chemotherapy versus placebo plus chemotherapy as assessed by BICR in the ITT set.

- To evaluate PFS in patients treated with pumitamig in combination with chemotherapy compared to placebo plus chemotherapy as assessed by investigator in the ITT set.

- To evaluate antitumor activity using ORR in patients treated with pumitamig in combination with chemotherapy compared to placebo plus chemotherapy in the ITT set as assessed by the investigator.

- To evaluate antitumor activity using DOR, and DCR in patients treated with pumitamig in combination with chemotherapy compared to placebo plus chemotherapy in the ITT set as assessed by BICR and by the investigator.

- To evaluate the PFS rate and OS rate at fixed timepoints in each treatment arm for the ITT set.

Protocol Number: 042601
Phase: Phase III
Applicable Disease Sites: Breast
Drugs Involved: BNT327(PM8002)
Principal Investigator: Mridula A George
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.