Recruiting NCT07173751

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

Phase III Interventional Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin.
Who it may be relevant to: Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, China +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The study consists of a:

1. Screening period (up to 28 days); 2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \[whichever comes first\]); 3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first).

Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors:

* Prior treatment with cancer immunotherapy (yes versus no) * On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin) * Geography (East Asia versus the rest of the world \[ROW\]) * PD-L1 status (combined positive score \[CPS\] less than \[\<\] 1 versus 1 less than or equal to \[\<=\] CPS \<10).

Interventions

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

Primary outcome measures

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 32 months]
Overall Survival (OS) [Time frame: Up to approximately 49 months]

Secondary outcome measures (12)

Objective Response Rate (ORR) as Assessed by BICR [Time frame: Up to approximately 49 months]
PFS [Time frame: Up to approximately 32 months]
ORR [Time frame: Up to approximately 49 months]
Duration of Response (DOR) [Time frame: Up to approximately 49 months]
Disease Control Rate (DCR) [Time frame: Up to approximately 32 months]
PFS Rate as Assessed by BICR [Time frame: At 6, 12, 18, and 24 months]
PFS Rate as Assessed by Investigator [Time frame: At 6, 12, 18, and 24 months]
OS Rate [Time frame: At 6, 12, 18, and 24 months]
Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship [Time frame: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)]
Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs) [Time frame: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)]
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status/Quality-of-Life score (Items 29 and 30) [Time frame: Baseline up to approximately 49 months]
Change from Baseline in EORTC QLQ-C30 Physical Functioning [Time frame: Baseline up to approximately 49 months]

Eligibility criteria

Inclusion criteria

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).
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion criteria

Have received any of the following therapies or drugs prior to the initiation of trial:

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.
Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment