A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
Launched by BRISTOL-MYERS SQUIBB · Apr 8, 2025
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The IZABRIGHT-Breast01 clinical trial is studying a new treatment option called Izalontamab Brengitecan (or iza-bren) for patients with a type of breast cancer known as triple-negative breast cancer (TNBC) or estrogen receptor-low, HER2-negative breast cancer. This trial is designed specifically for patients who have not yet received treatment and are not eligible for certain other therapies. The goal is to compare the safety and effectiveness of iza-bren against standard chemotherapy options chosen by doctors, such as paclitaxel or carboplatin.
To participate in this trial, patients need to have a confirmed diagnosis of advanced or recurrent breast cancer that meets specific criteria. They should also not have received any prior systemic therapy for their cancer. Additionally, participants should have measurable disease that can be seen on imaging tests like CT or MRI. The trial is currently not recruiting patients, but when it does start, participants can expect to receive treatment and regular follow-ups to monitor their health and response to the therapy. If you or someone you know may be interested in this trial, it's important to discuss eligibility and options with a healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
- • Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
- • Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:.
- • Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
- • Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
- • Has a severe auto-immune disease or other contraindication.
- • Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
- • No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
- • Measurable disease by CT or MRI as per RECIST v1.1.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Athens, , Greece
São Paulo, , Brazil
Padova, , Italy
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Newark, Delaware, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Covington, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
New York, New York, United States
New York, New York, United States
Westbury, New York, United States
White Plains, New York, United States
Durham, North Carolina, United States
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Greenville, South Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Midlothian, Virginia, United States
Roanoke, Virginia, United States
Winchester, Virginia, United States
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Río Cuarto, Córdoba, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Cordoba, , Argentina
Brisbane, Queensland, Australia
Ballarat Central, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Subiaco, Western Australia, Australia
Graz, Steiermark, Austria
Innsbruck, Tirol, Austria
Salzburg, , Austria
St. Polten, , Austria
Wien, , Austria
Manaus, Amazonas, Brazil
Fortaleza, Ceará, Brazil
Vitória, Espírito Santo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São José Do Rio Preto, São Paulo, Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Kelowna, British Columbia, Canada
Victoria, British Columbia, Canada
Ottawa, Ontario, Canada
Montréal, Quebec, Canada
Montréal, Quebec, Canada
Sherbrooke, Quebec, Canada
Medellín, Antioquia, Colombia
Rionegro, Antioquia, Colombia
Puerto Colombia, Atlántico, Colombia
Montería, Cor, Colombia
Cali, Valle Del Cauca, Colombia
Bordeaux, Aquitaine, France
Dijon, Côte D'or, France
Toulouse, Haute Garonne, France
Montpellier, Hérault, France
Rennes, Ille Et Vilaine, France
Saint Herblain, Loire Atlantique, France
Reims, Marne, France
Villejuif, Paris, France
Marseille, Provence Alpes Côte D'azur, France
Clermont Ferrand, Puy De Dôme, France
Lyon, Rhône Alpes, France
Lille, , France
Paris, , France
Augsburg, Bayern, Germany
München, Bayern, Germany
Frankfurt, Hessen, Germany
Düsseldorf, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Leipzig, Sachsen, Germany
Lübeck, Schleswig Holstein, Germany
Berlin, , Germany
Berlin, , Germany
Bonn, , Germany
Dresden, , Germany
Hannover, , Germany
Heidelberg, , Germany
Ulm, , Germany
Athens, Attikí, Greece
Athens, Attikí, Greece
Heraklion, Irakleío, Greece
New Delhi, Delhi, India
New Delhi, Delhi, India
Mumbai, Maharashtra, India
Nagpur, Maharashtra, India
Chennai, Tamil Nadu, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Petah Tikva, Hamerkaz, Israel
Ramat Gan, Hamerkaz, Israel
Hadera, Hatsafon, Israel
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Genova, Liguria, Italy
Pontedera, Pisa, Italy
Prato, Toscana, Italy
Milano, , Italy
Napoli, , Italy
Novara, , Italy
Roma, , Italy
Nagoya, Aichi, Japan
Chiba Shi, Chiba, Japan
Matsuyama, Ehime, Japan
Otashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa, Japan
Isehara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Tsu, Mie, Japan
Sendai Shi, Miyagi, Japan
Suita, Osaka, Japan
Hidaka, Saitama, Japan
Ina Machi, Saitama, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Koto, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Fukuoka, , Japan
Fukushima, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kyoto, , Japan
Okayama, , Japan
Osaka, , Japan
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Mexico City, Dif, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Merida, Yucatán, Mexico
Chihuahua, , Mexico
Biala Podlaska, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Opole, Opolskie, Poland
Skórzewo, Wielkopolskie, Poland
łódź, łódzkie, Poland
Lisbon, Lisboa, Portugal
Lisbon, Lisboa, Portugal
Lisbon, Lisboa, Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Porto, , Portugal
Bistrita, Bistrița Năsăud, Romania
Bucharest, București, Romania
Florești, Cluj, Romania
Craiova, Dolj, Romania
Timișoara, Timiș, Romania
București, , Romania
Cluj, , Romania
Iași, , Romania
Iași, , Romania
Ploiești, , Romania
A Coruña, A Coruña [La Coruña], Spain
Elche, Alicante, Spain
Barcelona, Barcelona [Barcelona], Spain
Hospitalet, Barcelona [Barcelona], Spain
Barcelona, Catalunya [Cataluña], Spain
San Sebastian, Gipuzkoa, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Malaga, Málaga, Spain
Valencia, Valenciana, Comunitat, Spain
Madrid, , Spain
Sevilla, , Spain
Malmö, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
örebro, , Sweden
Linköping, , Sweden
St.Gallen, Sankt Gallen, Switzerland
Lausanne, Vaud, Switzerland
Zürich, , Switzerland
Abu Dhabi, Abū Z̧aby, United Arab Emirates
Abu Dhabi, , United Arab Emirates
Truro, England, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Belfast, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Al Ain, Abū Z̧aby, United Arab Emirates
Hot Springs, Arkansas, United States
Cerritos, California, United States
Cerritos, California, United States
Cerritos, California, United States
O'fallon, Illinois, United States
Abu Dhabi, Abū Z̧aby, United Arab Emirates
New York, New York, United States
Esslingen, Baden Württemberg, Germany
Ploiești, Prahova, Romania
Barranquilla, Atlántico, Colombia
Bogota, Cundinamarca, Colombia
Whittier, California, United States
Abb, , Argentina
Río Cuarto, , Argentina
Fortaleza, , Brazil
Vitória, , Brazil
São José Do Rio Preto, , Brazil
Barranquilla, , Colombia
Puerto Colombia, , Colombia
Dijon, , France
Montpellier, , France
Marseille, , France
Clermont Ferrand, , France
Lyon, , France
Esslingen, , Germany
Athens, , Greece
Heraklion, , Greece
Goyang Si, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Daegu, , Korea, Republic Of
Monterrey, , Mexico
Merida, , Mexico
łódź, , Poland
Bistrita, , Romania
Bucharest, , Romania
Timișoara, , Romania
A Coruña, , Spain
Hospitalet, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Malaga, , Spain
Valencia, , Spain
Malmö, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
örebro, , Sweden
Linköping, , Sweden
Abu Dhabi, , United Arab Emirates
Abu Dhabi, , United Arab Emirates
Al Ain, , United Arab Emirates
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported