Phase
Condition
Neoplasms
Treatment
Doxorubicin
Rescue Medication
Capecitabine
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
Asociacion Española de Beneficencia ( Site 6403)
Guatemala City 3598132, 01015
GuatemalaActive - Recruiting
CELAN,S.A ( Site 6401)
Guatemala City 3598132, 01010
GuatemalaActive - Recruiting
INTEGRA Cancer Institute ( Site 6404)
Guatemala City 3598132, 01010
GuatemalaActive - Recruiting
MEDI-K ( Site 6400)
Guatemala City 3598132, 01009
GuatemalaActive - Recruiting
Onco Go, S.A ( Site 6402)
Guatemala City 3598132, 01010
GuatemalaActive - Recruiting
Queen Mary Hospital ( Site 1300)
Pokfulam,
Hong KongActive - Recruiting
Rambam Health Care Campus ( Site 4400)
Haifa 294801, 3109601
IsraelActive - Recruiting
Sheba Medical Center ( Site 4401)
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
National Hospital Organization Hokkaido Cancer Center ( Site 2300)
Sapporo 2128295, Hokkaido 2130037 003-0804
JapanActive - Recruiting
The University of Osaka Hospital ( Site 2314)
Suita 1851483, Osaka 1853904 565-0871
JapanActive - Recruiting
Showa Medical University Hospital ( Site 2306)
Shinagawa, Tokyo 1850144 142-8666
JapanActive - Recruiting
Chiba Cancer Center ( Site 2303)
Chiba 2113015, 260-8717
JapanActive - Recruiting
Fukushima Medical University Hospital ( Site 2301)
Fukushima 2112923, 960-1295
JapanActive - Recruiting
National Hospital Organization Osaka National Hospital ( Site 2315)
Osaka 1853909, 540-0006
JapanActive - Recruiting
Seoul National University Bundang Hospital ( Site 1801)
Kyonggi-do, Kyonggi-do 13620
South KoreaActive - Recruiting
Taichung Veterans General Hospital ( Site 1904)
Taichung 1668399, 407
TaiwanActive - Recruiting
National Taiwan University Hospital ( Site 1900)
Taipei 1668341, 10048
TaiwanActive - Recruiting
COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
Cherkasy, Cherkaska Oblast 18009
UkraineSite Not Available
COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
Cherkasy 710791, Cherkasy Oblast 710802 18009
UkraineActive - Recruiting
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 5208)
Chernivtsi 710719, Chernivetska Oblast 58013
UkraineActive - Recruiting
CNCE Precarpathian Clinical Oncologic Center ( Site 5201)
Ivano-Frankivsk 707471, Ivano-Frankivsk Oblast 707470 76018
UkraineActive - Recruiting
CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)
Kropyvnytsky, Kirovohrad Oblast 705811 25011
UkraineActive - Recruiting
Saint Joseph Hospital ( Site 0062)
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Bioresearch Partner ( Site 0072)
Hialeah, Florida 33013
United StatesSite Not Available
Bioresearch Partner ( Site 0072)
Hialeah 4158476, Florida 4155751 33013
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne, Indiana 46804
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne 4920423, Indiana 4921868 46804
United StatesActive - Recruiting
Franciscan Health ( Site 0077)
Indianapolis 4259418, Indiana 4921868 46237
United StatesActive - Recruiting
Louisiana State University Health Sciences Shreveport ( Site 0053)
Shreveport 4341513, Louisiana 4331987 71103
United StatesActive - Recruiting
New England Cancer Specialists ( Site 0051)
Westbrook, Maine 04092
United StatesSite Not Available
New England Cancer Specialists ( Site 0051)
Westbrook 4982753, Maine 4971068 04092
United StatesActive - Recruiting
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland 21202
United StatesSite Not Available
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore 4347778, Maryland 4361885 21202
United StatesActive - Recruiting
Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska 68516
United StatesSite Not Available
Cancer Partners of Nebraska ( Site 0068)
Lincoln 5072006, Nebraska 5073708 68516
United StatesActive - Recruiting
Renown Regional Medical Center ( Site 0041)
Reno, Nevada 89502
United StatesSite Not Available
Renown Regional Medical Center ( Site 0041)
Reno 5511077, Nevada 5509151 89502
United StatesActive - Recruiting
Altru Health System ( Site 0057)
Grand Forks, North Dakota 58201
United StatesSite Not Available
Altru Health System ( Site 0057)
Grand Forks 5059429, North Dakota 5690763 58201
United StatesActive - Recruiting
Nashville General Hospital ( Site 0017)
Nashville, Tennessee 37208
United StatesSite Not Available
Nashville General Hospital ( Site 0017)
Nashville 4644585, Tennessee 4662168 37208
United StatesActive - Recruiting
Oncology Consultants P.A. ( Site 0073)
Houston, Texas 77030
United StatesSite Not Available
Oncology Consultants P.A. ( Site 0073)
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington 98405
United StatesSite Not Available
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma 5812944, Washington 5815135 98405
United StatesActive - Recruiting
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