Phase
Condition
N/ATreatment
Sacituzumab tirumotecan
Paclitaxel
Gemcitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has locally recurrent unresectable or metastatic TNBC that cannot be treated withcurative intent
Has not received systemic treatment for locally recurrent unresectable or metastaticTNBC
Participants previously treated for early-stage breast cancer must have completedall prior therapy for early-stage breast cancer with curative intent at least 6months before the first disease recurrence
Is a candidate for treatment with one of the TPC options: paclitaxel ornab-paclitaxel or gemcitabine + carboplatin
Participants who have AEs due to previous anticancer therapies must have recoveredto ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participantswith endocrine-related AEs who are adequately treated with hormone replacement areeligible
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has breast cancer amenable to treatment with curative intent
Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression atcombined positive score (CPS) ≥10
Has received prior systemic therapy for treatment of locally recurrent unresectableor metastatic TNBC
Has Grade ≥2 peripheral neuropathy
Has history of documented severe dry eye syndrome, severe Meibomian gland diseaseand/or blepharitis, or corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has skin only metastatic disease
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolvinginto life-threatening complications
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi'ssarcoma and/or Multicentric Castleman's Disease
Has known additional malignancy that is progressing or has required active treatmentwithin the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Participants with previously treated brain metastases may participateprovided they are radiologically stable
Active autoimmune disease that has required systemic treatment in the past 2 years.Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) isallowed
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBVdeoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCVantibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
History of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgicalcomplications
Study Design
Connect with a study center
Fundacion Estudios Clinicos ( Site 2405)
Rosario, Santa Fe S2000DEJ
ArgentinaActive - Recruiting
Rabin Medical Center
Petah Tikva, Rinat 49100
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, Tal 5265601
IsraelActive - Recruiting
Rambam Health Care Campus ( Site 3700)
Haifa, 3109601
IsraelActive - Recruiting
Shaare Zedek Medical Center ( Site 3704)
Jerusalem, 9103102
IsraelActive - Recruiting
Rabin Medical Center ( Site 3702)
Petah Tikva, 4941492
IsraelActive - Recruiting
Sheba Medical Center ( Site 3701)
Ramat Gan, 5265601
IsraelActive - Recruiting
Sourasky Medical Center ( Site 3703)
Tel Aviv, 6423906
IsraelActive - Recruiting
Mie University Hospital ( Site 5109)
Tsu, Mie 514-8507
JapanActive - Recruiting
Showa Medical University Hospital ( Site 5103)
Shinagawa, Tokyo 142-8666
JapanActive - Recruiting
Seoul National University Bundang Hospital ( Site 5204)
Seongnam, Kyonggi-do 13620
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital ( Site 5205)
Daegu, Kyongsangbuk-do 41404
Korea, Republic ofActive - Recruiting
Samsung Medical Center ( Site 5203)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital ( Site 5200)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System ( Site 5201)
Seoul, 03722
Korea, Republic ofActive - Recruiting
National Cheng Kung University Hospital
Tainan, Wei-Pang 70403
TaiwanActive - Recruiting
Taichung Veterans General Hospital ( Site 5303)
Taichung, 407
TaiwanActive - Recruiting
National Cheng Kung University Hospital ( Site 5304)
Tainan, 70403
TaiwanActive - Recruiting
Mackay Memorial Hospital ( Site 5301)
Taipei, 104
TaiwanActive - Recruiting
Ironwood Cancer & Research Centers ( Site 0036)
Chandler, Arizona 85224
United StatesActive - Recruiting
Yale New Haven Hospital ( Site 0001)
New Haven, Connecticut 06510
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0015)
Las Vegas, Nevada 89119
United StatesActive - Recruiting
Renown Regional Medical Center ( Site 0005)
Reno, Nevada 89502
United StatesActive - Recruiting
Renown Regional Medical Center (Site number 0005)
Reno, Nevada 89502
United StatesActive - Recruiting
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
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