Phase
Condition
Neoplasms
Treatment
Doxorubicin
Rescue Medication
Epirubicin
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 previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymphnode (N) staging per AJCC 8th edition criteria as assessed by the investigator basedon radiological and/or clinical assessment:
cT1c, N1-N2
cT2, N0-N2
cT3, N0-N2
cT4a-d, N0-N2
The participant must have a centrally confirmed diagnosis of BC that istriple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expressionin 1% to 10% cells and HER2-), as by the most recent American Society of ClinicalOncology (ASCO)/College of American Pathologists (CAP) guidelines.
Provides a core needle biopsy from the primary breast tumor at screening to thecentral laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performedwithin 28 days before treatment randomization.
Demonstrates adequate organ function.
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
Has received any prior treatment, including radiation, systemic therapy,and/ordefinitive surgery for currently diagnosed breast cancer
Has undergone excisional biopsy of the primary tumor, axillary lymph nodedissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
Received prior systemic anticancer therapy including investigational agents within 4weeks before randomization.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or withan agent directed to another stimulatory or coinhibitory T-cell receptor (eg,CTLA-4, OX- 40, CD137).
Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I inhibitor-containing ADC.
Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention.
Known additional malignancy that is progressing or has required active treatmentwithin the past 5 years.
Uncontrolled systemic disease.
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.
Study Design
Connect with a study center
COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
Cherkasy, Cherkaska Oblast 18009
UkraineActive - Recruiting
CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)
Kropyvnytsky, Kirovohradska Oblast 25011
UkraineActive - Recruiting
Bioresearch Partner ( Site 0072)
Hialeah, Florida 33013
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
New England Cancer Specialists ( Site 0051)
Westbrook, Maine 04092
United StatesActive - Recruiting
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland 21202
United StatesActive - Recruiting
Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska 68516
United StatesActive - Recruiting
Renown Regional Medical Center ( Site 0041)
Reno, Nevada 89502
United StatesActive - Recruiting
Altru Health System ( Site 0057)
Grand Forks, North Dakota 58201
United StatesActive - Recruiting
Nashville General Hospital ( Site 0017)
Nashville, Tennessee 37208
United StatesActive - Recruiting
Oncology Consultants P.A. ( Site 0073)
Houston, Texas 77030
United StatesActive - Recruiting
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington 98405
United StatesActive - Recruiting
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