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ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
558 patients around the world
Available in Spain, Brazil
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).
BioNTech SE
3Research sites
558Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Brasília
Recruiting
UPCO Unidade de Pesquisa Clinica em Oncologia
Recruiting
Hospital Santa Rita
Recruiting
SponsorBioNTech SE
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07173751
