Health Trials

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

ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor [PgR]) 1% to 10%, HER2 immunohistochemistry [IHC] 0, 1+, or 2+ with fluorescence in situ hybridization [FISH] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.

Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.

Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).

Disqualifiers

Have received prior systemic anticancer therapy for advanced disease.

Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.

Have received systemic corticosteroids (at a dosage greater than 10 milligrams [mg]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).

Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

558 Participants
are divided into 2 treatment groups
Group A: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) ChemotherapyExperimental treatment 5 interventions
Group B: Arm 2: Placebo + TPC ChemotherapyPlacebo comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors \[RECIST\] v1.1), or death from any cause, whichever occurs first.

Time frame
Up to approximately 32 months
2

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause.

Time frame
Up to approximately 49 months

Secondary outcomes

1

Objective Response Rate (ORR) as Assessed by BICR

ORR is defined as the percentage of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) as per RECIST v1.1 is assessed by BICR as best overall response.

Time frame
Up to approximately 49 months
2

PFS

PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.

Time frame
Up to approximately 32 months
3

ORR

ORR is defined as the percentage of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response.

Time frame
Up to approximately 49 months
4

Duration of Response (DOR)

DOR is defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.

Time frame
Up to approximately 49 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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