Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 26, 2024

Primary Completion Date

August 31, 2028

Study Completion Date

June 30, 2029

Conditions
Locally Advanced Breast CancerTriple Negative Breast CancerMetastatic Triple Negative Breast Cancers
Interventions
DRUG

BNT327 Dose Level 1 (DL1)

Intravenous (IV) infusion

DRUG

BNT327 Dose Level 1 (DL2)

IV infusion

DRUG

Nab-placlitaxel

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Eribulin

IV infusion

DRUG

BNT327 Optimized Dose

IV infusion

DRUG

BNT327 Equivalent Q3W Dose

IV infusion

Trial Locations (62)

2065

WITHDRAWN

Mater Hospital Sydney, Sydney

2145

WITHDRAWN

Westmead Hospital, Westmead

3050

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3199

ACTIVE_NOT_RECRUITING

Peninsula Oncology Centre, Frankston

4065

WITHDRAWN

Icon Cancer Care, Wesley Clinic, Auchenflower

11590

WITHDRAWN

Clinical Research Alliance Inc., Westbury

11794

RECRUITING

Stony Brook University Hospital, Stony Brook

23114

RECRUITING

Bon Secours St. Francis Medical Center, Midlothian

23502

RECRUITING

Virginia Oncology Associates, Norfolk

28374

NOT_YET_RECRUITING

FirstHealth Outpatient Cancer Center, Pinehurst

34010

TERMINATED

Koc Universitesi Hastanesi (Koc University Hospital), Istanbul

34093

ACTIVE_NOT_RECRUITING

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Istanbul

34517

WITHDRAWN

Istinye Universitesi Bahcesehir Liv Hospital, Istanbul

34722

TERMINATED

Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

34755

ACTIVE_NOT_RECRUITING

Yeditepe University Hospital, Istanbul

34952

WITHDRAWN

Hematology Oncology Associates of Treasure Coast, Port Saint Lucie

35325

RECRUITING

Medical Point Izmir Hospital, Izmir

36020

WITHDRAWN

Gaziantep Sanko University Medical Faculty, Gaziantep

37203

RECRUITING

SCRI Oncology Partners, Nashville

37920

WITHDRAWN

University of Tennessee Medical Center, Knoxville

38138

RECRUITING

The West Clinic, P.C. d/b/a West Cancer Center, Germantown

46250

NOT_YET_RECRUITING

Community Health Network, Indianapolis

46311

WITHDRAWN

Northwest Cancer Centers, P.C., Dyer

48202

WITHDRAWN

Henry Ford Hospital, Detroit

52403

RECRUITING

Helen G. Nassif Community Cancer Center, Cedar Rapids

54290

ACTIVE_NOT_RECRUITING

Sakarya University - Faculty of Medicine, Adapazarı

55125

RECRUITING

Minnesota Oncology - Woodbury Clinic, Woodbury

55139

WITHDRAWN

Ondokuz Mayis Universitesi Tip Fakultesi, Samsun

55426

RECRUITING

HealthPartners Regions Specialty Clinics, Saint Louis Park

59715

WITHDRAWN

Bozeman Health Deaconess Hospital Cancer Center, Bozeman

60077

WITHDRAWN

Orchard Healthcare Research Inc., Skokie

61801

RECRUITING

Carle Foundation Hospital d/b/a Carle Cancer Center, Urbana

80220

RECRUITING

Rocky Mountain Cancer Centers (RMCC), Denver

85711

NOT_YET_RECRUITING

Arizona Oncology Associates, PC, Tucson

90067

SUSPENDED

Valkyrie Clinical Trials, Los Angeles

90211

RECRUITING

Beverly Hills Cancer Center, Beverly Hills

96813

WITHDRAWN

Kaiser Permanente - Moanalua Medical Center And Clinic, Honolulu

98684

NOT_YET_RECRUITING

Northwest Cancer Specialists, Vancouver

94304-2201

RECRUITING

Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center, Palo Alto

90404-2312

RECRUITING

Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica

06520

NOT_YET_RECRUITING

Yale University - Yale Cancer Center, New Haven

ACTIVE_NOT_RECRUITING

Memorial Ankara Hospital, Ankara

08901

RECRUITING

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), New Brunswick

75246-2006

NOT_YET_RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

78229-4427

WITHDRAWN

Ut Health Science Center - San Antonio (UTHSCSA), Cancer Therapy & Research Center, San Antonio

01120

ACTIVE_NOT_RECRUITING

Baskent Universitesi Tip Fakultesi Adana Hastanesi, Adana

01230

ACTIVE_NOT_RECRUITING

Medical Park Seyhan Hospital, Adana

01370

WITHDRAWN

Adana City Training and Research Hospital, Adana

06010

WITHDRAWN

Gulhane Egitim ve Arastirma Hastanesi, Ankara

06100

ACTIVE_NOT_RECRUITING

Hacettepe Universitesi Kanser Enstitusu, Ankara

RECRUITING

Sbu Dr.A.Y. Ankara Onkoloji SUAM, Ankara

06800

WITHDRAWN

Ankara City Hospital, Ankara

01130

WITHDRAWN

Acibadem Adana Hospital, Seyhan

06560

WITHDRAWN

Gazi University Medical Faculty, Yenimahalle

HP21 8AL

ACTIVE_NOT_RECRUITING

Stoke Mandeville Hospital - Buckinghamshire Healthcare NHS Trust, Aylesbury

HU16 5JQ

ACTIVE_NOT_RECRUITING

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital, Cottingham

EH4 2LF

ACTIVE_NOT_RECRUITING

Edinburgh Cancer Centre-Western General Hospital, Edinburgh

LS9 7TF

ACTIVE_NOT_RECRUITING

St James's University Hospital - Leeds Teaching Hospitals NHS Trust, Leeds

EC1A 7BE

ACTIVE_NOT_RECRUITING

St Bartholomew's Hospital - Barts Health NHS Trust, London

NW2 1PG

ACTIVE_NOT_RECRUITING

University College London Hospitals NHS Foundation Trust, London

W1G 6AD

RECRUITING

Sarah Cannon Research Institute, London

NG5 1PB

WITHDRAWN

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioNTech SE

INDUSTRY