Testing Pumitamig with Nab-paclitaxel/Paclitaxel against a placebo for breast neoplasms
Official title: ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
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
- Phase 3
- 2 groups
- Sites in Québec and Toronto
- Recruiting
Interventions (6)
- Medication
Pumitamig
Solution for intravenous (IV) infusion
- Medication
Nab-paclitaxel/Paclitaxel
IV infusion
- Medication
Gemcitabine
IV infusion
- Medication
Carboplatin
IV infusion
- Medication
Eribulin
IV infusion
- Medication
Matching placebo
IV infusion
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont
Québec
- Recruiting
Sunnybrook Research Unit-Cognitive Neurology Research Unit in the Hurvitz Brain Science Research Program
Toronto
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → as part of standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →.
- +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.
- +Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
Exclusion
- −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 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 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.
- −Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- −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 placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Pumitamig, together with one or more of: Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin and Eribulin.
Registry label: A: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives one or more of: Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin and Matching placebo.
Registry label: B: Arm 2: Placebo + TPC Chemotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 558 people.
The study is currently expected to finish around September 2030.
The main measurement is taken over: Up to approximately 32 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) — measured over Up to approximately 32 months.
Overall Survival (OS) — measured over Up to approximately 49 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07173751 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PumitamigDrug
Solution for intravenous (IV) infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Nab-paclitaxel/PaclitaxelDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GemcitabineDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EribulinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Matching placeboDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 32 months.
The study as a whole is currently expected to finish around 2030-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 558 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Québec, Canada; Toronto, Canada; Detroit, Michigan, United States; Royal Oak, Michigan, United States; Saint Louis Park, Minnesota, United States; Saint Paul, Minnesota, United States, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (17)
Karmanos Cancer Center
Detroit, Michigan, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, United States
Healthpartners Regions Specialty Clinics
Saint Louis Park, Minnesota, United States
Healthpartners Regions Specialty Clinics
Saint Paul, Minnesota, United States
Paradigm New York Cancer and Blood Specialists
Bay Shore, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Paradigm New York Cancer and Blood Specialists
New York, New York, United States
Rochester General Hospital Lipson Cancer Institute
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.