Phase
Condition
Neoplasms
Treatment
Olaparib
Doxorubicin
Rescue Medication
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
Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)
Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
ArgentinaActive - Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 6005)
Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1431FWO
ArgentinaActive - Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)
San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000IHE
ArgentinaActive - Recruiting
Sanatorio Allende - Nueva Córdoba ( Site 6000)
Córdoba 3860259, X5000BFB
ArgentinaActive - Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 6111)
Natal 3394023, Rio Grande do Norte 3390290 59062-000
BrazilActive - Recruiting
Hospital de Base de São José do Rio Preto ( Site 6101)
São José do Rio Preto 3448639, São Paulo 3448433 15090-000
BrazilActive - Recruiting
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)
Québec 6325494, Quebec 6115047 G1S 4L8
CanadaActive - Recruiting
Anhui Provincial Cancer Hospital ( Site 2234)
Hefei 1808722, Anhui 1818058 230031
ChinaActive - Recruiting
Beijing Cancer Hospital ( Site 2201)
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaActive - Recruiting
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2224)
Xiamen 1790645, Fujian 1811017 361009
ChinaActive - Recruiting
Guangdong Maternity and Child Health Care Hospital ( Site 2251)
Guangzhou 1809858, Guangdong 1809935 511400
ChinaActive - Recruiting
Jiangmen Center Hospital ( Site 2243)
Jiangmen 1806299, Guangdong 1809935 529030
ChinaActive - Recruiting
Liuzhou People's Hospital ( Site 2259)
Liuzhou 1803300, Guangxi 1809867 545006
ChinaActive - Recruiting
Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)
Nanning 1799869, Guangxi 1809867 530201
ChinaActive - Recruiting
Henan Cancer Hospital ( Site 2238)
Zhengzhou 1784658, Henan 1808520 450000
ChinaActive - Recruiting
Wuhan Union Hospital ( Site 2239)
Wuhan 1791247, Hubei 1806949 430000
ChinaActive - Recruiting
Jiangsu Province Hospital ( Site 2216)
Nanjing 1799962, Jiangsu 1806260 210036
ChinaActive - Recruiting
Nanjing Drum Tower Hospital ( Site 2217)
Nanjing 1799962, Jiangsu 1806260 210008
ChinaActive - Recruiting
The Third Hospital Of Nanchang ( Site 2218)
Nanchang 1800163, Jiangxi 1806222 330025
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2203)
Xi'an 1790630, Shaanxi 1796480 710000
ChinaActive - Recruiting
Jinan Central Hospital ( Site 2249)
Jinan 1805753, Shandong 1796328 250013
ChinaActive - Recruiting
Shandong Cancer Hospital ( Site 2205)
Jinan 1805753, Shandong 1796328 250117
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center ( Site 2209)
Shanghai 1796236, Shanghai Municipality 1796231 200000
ChinaActive - Recruiting
Deyang City People's Hospital ( Site 2244)
Deyang 1812961, Sichuan 1794299 618099
ChinaActive - Recruiting
The Second People's Hospital of Neijiang ( Site 2242)
Neijiang 1799491, Sichuan 1794299 641099
ChinaActive - Recruiting
Yunnan Province Cancer Hospital ( Site 2226)
Kunming 1804651, Yunnan 1785694 650118
ChinaActive - Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)
Hangzhou 1808926, Zhejiang 1784764 310017
ChinaActive - Recruiting
Zhejiang Cancer Hospital ( Site 2211)
Hangzhou 1808926, Zhejiang 1784764 310022
ChinaSite Not Available
Zhejiang Provincial People's Hospital ( Site 2215)
Hangzhou 1808926, Zhejiang 1784764 311599
ChinaActive - Recruiting
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
Hong Kong United Oncology Centre ( Site 1304)
Jordan 8224045,
Hong KongActive - Recruiting
Queen Mary Hospital ( Site 1300)
Pokfulam,
Hong KongActive - Recruiting
Prince of Wales Hospital ( Site 1301)
Shatin 1818920,
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
Kanagawa Cancer Center ( Site 2308)
Yokohama 1848354, Kanagawa 1860291 241-8515
JapanActive - Recruiting
Kansai Medical University Hospital ( Site 2317)
Hirakata 1862540, Osaka 1853904 573-1191
JapanActive - Recruiting
The University of Osaka Hospital ( Site 2314)
Suita 1851483, Osaka 1853904 565-0871
JapanActive - Recruiting
Shizuoka Cancer Center ( Site 2309)
Sunto-gun, Shizuoka 1851715 411-8777
JapanActive - Recruiting
Showa Medical University Hospital ( Site 2306)
Shinagawa, Tokyo 1850144 142-8666
JapanActive - Recruiting
Akita University Hospital ( Site 2302)
Akita 2113126, 010-8543
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
Kyoto University Hospital ( Site 2313)
Kyoto 1857910, 606-8507
JapanActive - Recruiting
National Hospital Organization Osaka National Hospital ( Site 2315)
Osaka 1853909, 540-0006
JapanActive - Recruiting
National Cancer Centre Singapore ( Site 1700)
Singapore 1880252, Central Singapore 168583
SingaporeActive - Recruiting
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)
Port Elizabeth 964420, Eastern Cape 1085593 6045
South AfricaActive - Recruiting
Wits Clinical Research ( Site 4903)
Johannesburg 993800, Gauteng 1085594 2193
South AfricaActive - Recruiting
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)
Pretoria 964137, Gauteng 1085594 0181
South AfricaActive - Recruiting
Sandton Oncology Medical Group (Pty) Ltd ( Site 4900)
Sandton 957654, Gauteng 1085594 2196
South AfricaActive - Recruiting
Cancercare Rondebosch Oncology ( Site 4906)
Cape Town 3369157, Western Cape 1085599 7700
South AfricaActive - Recruiting
Seoul National University Bundang Hospital ( Site 1801)
Kyonggi-do, Kyonggi-do 13620
South KoreaActive - Recruiting
Asan Medical Center ( Site 1803)
Seoul 1835848, 05505
South KoreaActive - Recruiting
Seoul National University Hospital ( Site 1806)
Seoul 1835848, 03080
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System ( Site 1804)
Seoul 1835848, 03722
South KoreaActive - Recruiting
Taichung Veterans General Hospital ( Site 1904)
Taichung 1668399, 407
TaiwanActive - Recruiting
MacKay Memorial Hospital ( Site 1903)
Taipei 1668341, 10449
TaiwanActive - Recruiting
National Taiwan University Cancer Center (NTUCC) ( Site 1901)
Taipei 1668341, 106
TaiwanActive - Recruiting
National Taiwan University Hospital ( Site 1900)
Taipei 1668341, 10048
TaiwanActive - Recruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 1906)
Taoyuan District 1667905, 333
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
Shalimov Institute of Surgery and Transplantation ( Site 5210)
Kyiv 703448, 03126
UkraineActive - Recruiting
St Bartholomew s Hospital ( Site 5302)
London 2643743, London, City of EC1A 7BE
United KingdomActive - Recruiting
Providence Medical Foundation ( Site 0080)
Fullerton 5351247, California 5332921 92835
United StatesActive - Recruiting
Saint Joseph Hospital ( Site 0062)
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0054)
Grand Junction 5423573, Colorado 5417618 81501
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
Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)
Cincinnati 4508722, Ohio 5165418 45220
United StatesActive - Recruiting
Avera McKennan Hospital ( Site 0002)
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesActive - Recruiting
Avera Cancer Institute - Yankton ( Site 0089)
Yankton 5233053, South Dakota 5769223 57078
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
Hendrick Medical Center ( Site 0009)
Abilene 4669635, Texas 4736286 79601
United StatesActive - Recruiting
JPS Oncology and Infusion Center ( Site 0083)
Fort Worth 4691930, Texas 4736286 76104
United StatesActive - Recruiting
Oncology Consultants P.A. ( Site 0073)
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Bon Secours Cancer Institute at St. Francis ( Site 0048)
Midlothian 4772943, Virginia 6254928 23114
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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