ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Phase 3 – large-scale trial before approval
Conditions:
Breast Neoplasms
Sponsor: BioNTech SE
trial.available_in:
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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.
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).
Who can participate
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.
Interventions
Pumitamig
DRUG
Nab-paclitaxel/Paclitaxel
DRUG
Gemcitabine
DRUG
Carboplatin
DRUG
Eribulin
DRUG
Matching placebo
DRUG
Locations
63
Australia (2)
GenesisCare St Andrew's Precinct
Adelaide , South Australia
Peninsula & South Eastern Hematology and Oncology Group
Frankston , Victoria
Belgium (2)
Grand hospital de Charleroi
Gilly
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
China (1)
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai
Georgia (4)
High Technology Hospital Medcenter LTD
Batumi
Multiprofile Clinic Consilium Medulla
Tbilisi
LLC Todua Clinic
Tbilisi
Caucasus Medical Centre
Tbilisi
Germany (1)
Institut fuer Versorgungsforschung in der Onkologie
Koblenz
Italy (2)
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan
IRCCS-Istituto Europeo di Oncologia
Milan
Japan (6)
Chiba Cancer Center
Chiba
Gifu University Hospital
Gifu
Hiroshima City Hiroshima Citizens Hospital
Hiroshima
Kumamoto University Hospital
Kumamoto
Tohoku University Hospital
Sendai
National Center For Global Health And Medicine
Shinjuku-Ku
Poland (1)
IP Clinic Sp. z o.o.
Lodz
South Korea (7)
Soon Chun Hyang University Cheonan Hospital
Cheonan
Chungbuk National University Hospital
Cheongju-si
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si
Korea University Anam Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Asan Medical Center (AMC)
Seoul
Ajou University Hospital
Suwon
Spain (9)
Parc de Salut Mar - Hospital del Mar
Barcelona
Institut Oncologic Rosell - Hospital General De Catalunya
Barcelona
Hospital Universitario Reina Sofia
Córdoba
IOB Institute of Oncology - Beata Maria Ana Hospital
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
Pamplona
Hospital Universitari Parc Tauli
Sabadell
United Kingdom (11)
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
Bristol
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham
Edinburgh Cancer Centre-Western General Hospital
Edinburgh
University College London Hospitals NHS Foundation Trust
London
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London
Sarah Cannon Research Institute
London
North Wales Cancer Treatment C - Glan Clwyd Hospital
Rhyl
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton
United States (17)
Lahey Hospital & Medical Center
Burlington , Massachusetts
Cancer Care Specialists
Decatur , Illinois
Summit Medical Group PA
Florham Park , New Jersey
The West Clinic, P.C. dba West Cancer Center
Germantown , Tennessee
Oncology Consultants PA
Houston , Texas
Oncology Consultants PA
Houston , Texas
Cancer Care Specialists of Illinois
O'Fallon , Illinois
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha , Nebraska
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto , California
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak , Michigan
Oregon Oncology Specialists
Salem , Oregon
Highlands Oncology Group
Springdale , Arkansas
Stony Brook University Medical Center
Stony Brook , New York
Northwest Medical Specialties, PLLC
Tacoma , Washington
Montefiore Medical Center
The Bronx , New York
Carle Foundation Hospital d/b/a Carle Cancer Center