Phase
Condition
Breast Cancer
Cancer
Treatment
Paclitaxel
Epirubicin
Dato-DXd
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 years, at the time of signing the ICF.
Histologically confirmed Stage II or III unilateral or bilateral primary invasiveTNBC or hormone receptor-low/HER2-negative breast cancer
ECOG PS of 0 or 1
Provision of acceptable tumor sample
Adequate bone marrow reserve and organ function
Contraceptive use by males or females should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studiesand aligned with protocol requirements.
Exclusion
Exclusion criteria:
History of any prior invasive breast malignancy
History of another primary malignancy except for malignancy treated with curativeintent with no known active disease within 5 years before randomization.
active or prior documented autoimmune or inflammatory disorders.
Evidence of distant disease.
Clinically significant corneal disease.
Has active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals;suspected infections; or inability to rule out infections.
Known to have active tuberculosis infection
Mean resting corrected QTcF interval > 470 ms obtained from ECG
Uncontrolled or significant cardiac disease.
History of non-infectious ILD/pneumonitis
Has severe pulmonary function compromise
Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy forTNBC or hormone receptor-low/HER2-negative breast cancer
For females only: is pregnant (confirmed with positive serum pregnancy test) orbreastfeeding, or planning to become pregnant.
Female participants should refrain from breastfeeding from enrolment throughout thestudy and for at least 7 months after last dose of study intervention, or asdictated by local PI for SoC if longer.
Concurrent use of systemic hormone replacement therapy or oral hormonalcontraception
Study Design
Study Description
Connect with a study center
Research Site
Darlinghurst, 2010
AustraliaSite Not Available
Research Site
East Melbourne, 3002
AustraliaActive - Recruiting
Research Site
Heidelberg, 3084
AustraliaSite Not Available
Research Site
Herston, 4029
AustraliaSite Not Available
Research Site
Nedlands, 6009
AustraliaSite Not Available
Research Site
Waratah, 2298
AustraliaSite Not Available
Research Site
Feldkirch, 6807
AustriaActive - Recruiting
Research Site
Graz, 8036
AustriaActive - Recruiting
Research Site
Innsbruck, 6020
AustriaActive - Recruiting
Research Site
Linz, 4010
AustriaActive - Recruiting
Research Site
Salzburg, 5020
AustriaActive - Recruiting
Research Site
Brasschaat, 2930
BelgiumActive - Recruiting
Research Site
Charleroi, 6060
BelgiumActive - Recruiting
Research Site
Gent, 9000
BelgiumActive - Recruiting
Research Site
Leuven, 3000
BelgiumActive - Recruiting
Research Site
Libramont-Chevigny, 6800
BelgiumActive - Recruiting
Research Site
Wilrijk, 2610
BelgiumActive - Recruiting
Research Site
Brasilia, 71681-603
BrazilActive - Recruiting
Research Site
Curitiba, 80440-220
BrazilActive - Recruiting
Research Site
Fortaleza, 60336-045
BrazilActive - Recruiting
Research Site
Londrina, 86015-520
BrazilActive - Recruiting
Research Site
Natal, 59075-740
BrazilActive - Recruiting
Research Site
Porto Alegre, 90035-903
BrazilActive - Recruiting
Research Site
Ribeirão Preto, 14051-140
BrazilActive - Recruiting
Research Site
Santo Andre, 09060-650
BrazilActive - Recruiting
Research Site
São Paulo, 01246-000
BrazilActive - Recruiting
Research Site
Taubaté, 12030-200
BrazilActive - Recruiting
Research Site
Vitória, 29043-260
BrazilActive - Recruiting
Research Site
Plovdiv, 4004
BulgariaSite Not Available
Research Site
Shumen, 9700
BulgariaActive - Recruiting
Research Site
Sofia, 1431
BulgariaActive - Recruiting
Research Site
Vratza, 3000
BulgariaSite Not Available
Research Site
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
Research Site
Abbotsford, British Columbia V2S0C2
CanadaSite Not Available
Research Site
Vancouver, British Columbia VSZ 4E6
CanadaActive - Recruiting
Research Site
St. John's, Newfoundland and Labrador A1B 3V6
CanadaSite Not Available
Research Site
Barrie, Ontario L4M 6M2
CanadaActive - Recruiting
Research Site
London, Ontario N6A 5W9
CanadaActive - Recruiting
Research Site
Oshawa, Ontario L1G 2B9
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Research Site
Levis, Quebec G6V 3Z1
CanadaActive - Recruiting
Research Site
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Research Site
St-Jerome, Quebec J7Z 5T3
CanadaActive - Recruiting
Research Site
Saskatoon, Saskatchewan S7N 4H4
CanadaSite Not Available
Research Site
Montreal, H3T 1E2
CanadaActive - Recruiting
Research Site
Ottawa, K1H 8L6
CanadaActive - Recruiting
Research Site
Beijing, 211405
ChinaSite Not Available
Research Site
Bengbu, 233060
ChinaActive - Recruiting
Research Site
Changchun, 130021
ChinaSite Not Available
Research Site
Changsha, 410013
ChinaSite Not Available
Research Site
Chengdu, 610000
ChinaActive - Recruiting
Research Site
Chongqing, 400030
ChinaSite Not Available
Research Site
Guangzhou, 510060
ChinaActive - Recruiting
Research Site
Hangzhou, 310022
ChinaActive - Recruiting
Research Site
Harbin, 150049
ChinaActive - Recruiting
Research Site
Hefei, 230012
ChinaSite Not Available
Research Site
Jinan, 250117
ChinaActive - Recruiting
Research Site
Kunming, 650118
ChinaSite Not Available
Research Site
Linhai, 318000
ChinaActive - Recruiting
Research Site
Nanchang, 330029
ChinaActive - Recruiting
Research Site
Nanjing, 210029
ChinaSite Not Available
Research Site
Nanning, 530021
ChinaActive - Recruiting
Research Site
Shanghai, 200025
ChinaActive - Recruiting
Research Site
Shenyang, 110004
ChinaActive - Recruiting
Research Site
Shijiazhuang, 050020
ChinaActive - Recruiting
Research Site
Suining, 629000
ChinaActive - Recruiting
Research Site
Suzhou, 215004
ChinaActive - Recruiting
Research Site
Tianjin, 300000
ChinaActive - Recruiting
Research Site
Urumqi, 830000
ChinaSite Not Available
Research Site
Wuhan, 430022
ChinaActive - Recruiting
Research Site
Xi'an, 710061
ChinaActive - Recruiting
Research Site
Xintai, 54031
ChinaActive - Recruiting
Research Site
Zhaoqing, 526000
ChinaActive - Recruiting
Research Site
Zhengzhou, 450008
ChinaActive - Recruiting
Research Site
Angers, 49100
FranceSite Not Available
Research Site
Avignon, 84918
FranceActive - Recruiting
Research Site
Bayonne, 64100
FranceActive - Recruiting
Research Site
Caen Cedex 5, 41076
FranceActive - Recruiting
Research Site
Clermont Ferrand, 63011
FranceSite Not Available
Research Site
Limoges, 87000
FranceActive - Recruiting
Research Site
Lyon, 69373
FranceSite Not Available
Research Site
Marseille, 13273
FranceActive - Recruiting
Research Site
Montpellier, 34298
FranceActive - Recruiting
Research Site
Nice, 06100
FranceSite Not Available
Research Site
Paris, 75010
FranceActive - Recruiting
Research Site
Reims Cedex, 51056
FranceActive - Recruiting
Research Site
Saint Herblain, 44805
FranceSite Not Available
Research Site
Toulouse, 31100
FranceActive - Recruiting
Research Site
Vandoeuvre les Nancy, 54519
FranceActive - Recruiting
Research Site
Villejuif Cedex, 94805
FranceActive - Recruiting
Research Site
Augsburg, 86150
GermanyActive - Recruiting
Research Site
Berlin, 13125
GermanyActive - Recruiting
Research Site
Dessau-Roßlau, 06847
GermanyActive - Recruiting
Research Site
Dresden, 01307
GermanyActive - Recruiting
Research Site
Erlangen, 91054
GermanyActive - Recruiting
Research Site
Essen, 45130
GermanyActive - Recruiting
Research Site
Esslingen am Neckar, 73730
GermanyActive - Recruiting
Research Site
Frankfurt am Main, 60431
GermanyActive - Recruiting
Research Site
Freiburg, 79110
GermanyActive - Recruiting
Research Site
Hamburg, 20246
GermanySite Not Available
Research Site
Hannover, 30559
GermanyActive - Recruiting
Research Site
Heidelberg, 69120
GermanyActive - Recruiting
Research Site
Kiel, 24105
GermanyActive - Recruiting
Research Site
Mainz, 55131
GermanyActive - Recruiting
Research Site
Mannheim, 68167
GermanyActive - Recruiting
Research Site
München, 80637
GermanyActive - Recruiting
Research Site
Münster, 48149
GermanyActive - Recruiting
Research Site
Trier, 54290
GermanyActive - Recruiting
Research Site
Ulm, 89075
GermanyActive - Recruiting
Research Site
Hong Kong, 999077
Hong KongActive - Recruiting
Research Site
Kwai Chung, 999077
Hong KongSite Not Available
Research Site
Budapest, 1122
HungaryActive - Recruiting
Research Site
Kecskemét, 6000
HungaryActive - Recruiting
Research Site
Miskolc, 3526
HungaryActive - Recruiting
Research Site
Nyíregyháza, 4400
HungarySite Not Available
Research Site
Salgótarján, 3100
HungarySite Not Available
Research Site
Szekszárd, 7100
HungaryActive - Recruiting
Research Site
Bengaluru, 560085
IndiaActive - Recruiting
Research Site
Dehradun, 248016
IndiaSite Not Available
Research Site
Delhi, 110029
IndiaActive - Recruiting
Research Site
Kolkata, 700099
IndiaActive - Recruiting
Research Site
Marg Jaipur, 302004
IndiaActive - Recruiting
Research Site
Nagpur, 440001
IndiaActive - Recruiting
Research Site
Nashik, 422011
IndiaActive - Recruiting
Research Site
Puducherry, 605006
IndiaSite Not Available
Research Site
Thiruvananthapuram, 695011
IndiaActive - Recruiting
Research Site
Vadodara, 391760
IndiaActive - Recruiting
Research Site
Empoli, 50053
ItalyActive - Recruiting
Research Site
Lucca, 55100
ItalyActive - Recruiting
Research Site
Macerata, 62100
ItalyActive - Recruiting
Research Site
Milano, 20132
ItalyActive - Recruiting
Research Site
Modena, 41124
ItalyActive - Recruiting
Research Site
Napoli, 80131
ItalyActive - Recruiting
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Roma, 00168
ItalyActive - Recruiting
Research Site
Rozzano, 20089
ItalyActive - Recruiting
Research Site
Torino, 10126
ItalyActive - Recruiting
Research Site
Tricase, 73039
ItalyActive - Recruiting
Research Site
Udine, 33100
ItalyActive - Recruiting
Research Site
Akashi-shi, 673-8558
JapanActive - Recruiting
Research Site
Akita-shi, 010-8543
JapanActive - Recruiting
Research Site
Bunkyo-ku, 113-8431
JapanActive - Recruiting
Research Site
Chiba-shi, 260-8717
JapanActive - Recruiting
Research Site
Chuo-ku, 104-8560
JapanActive - Recruiting
Research Site
Fukuoka-shi, 811-1395
JapanActive - Recruiting
Research Site
Fukushima-shi, 960-1295
JapanActive - Recruiting
Research Site
Gifu-shi, 501-1194
JapanActive - Recruiting
Research Site
Hidaka-shi, 350-1298
JapanActive - Recruiting
Research Site
Hirakata-shi, 573-1191
JapanActive - Recruiting
Research Site
Hiroshima-shi, 734-8551
JapanActive - Recruiting
Research Site
Isehara-shi, 259-1193
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Kumamoto-shi, 860-8556
JapanActive - Recruiting
Research Site
Kurume-shi, 830-0011
JapanActive - Recruiting
Research Site
Kyoto-shi, 606-8507
JapanActive - Recruiting
Research Site
Matsuyama-shi, 791-0280
JapanActive - Recruiting
Research Site
Nagoya-shi, 466-8560
JapanActive - Recruiting
Research Site
Niigata-shi, 951-8566
JapanActive - Recruiting
Research Site
Okayama, 700-8558
JapanActive - Recruiting
Research Site
Osaka-shi, 541-8567
JapanActive - Recruiting
Research Site
Sapporo-shi, 003-0804
JapanActive - Recruiting
Research Site
Sendai-shi, 980-8574
JapanActive - Recruiting
Research Site
Shinagawa-ku, 142-8666
JapanActive - Recruiting
Research Site
Shinjuku-ku, 160-0023
JapanActive - Recruiting
Research Site
Sunto-gun, 411-8777
JapanActive - Recruiting
Research Site
Tokyo, 104-0045
JapanActive - Recruiting
Research Site
Tsu-shi, 514-8507
JapanActive - Recruiting
Research Site
Yokohama-shi, 241-8515
JapanActive - Recruiting
Research Site
Daegu, 41404
Korea, Republic ofSite Not Available
Research Site
Goyang-si, 10408
Korea, Republic ofSite Not Available
Research Site
Seongnam, 13620
Korea, Republic ofSite Not Available
Research Site
Seoul, 05505
Korea, Republic ofSite Not Available
Research Site
George Town, 10990
MalaysiaActive - Recruiting
Research Site
Kuala Lumpur, 50586
MalaysiaActive - Recruiting
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Selangor, 62250
MalaysiaActive - Recruiting
Research Site
Bialystok, 15-027
PolandActive - Recruiting
Research Site
Bydgoszcz, 85-796
PolandActive - Recruiting
Research Site
Gdańsk, 80-214
PolandSite Not Available
Research Site
Gdynia, 81-519
PolandActive - Recruiting
Research Site
Kraków, 31-501
PolandActive - Recruiting
Research Site
Tomaszów Mazowiecki, 97-200
PolandSuspended
Research Site
Warszawa, 02-781
PolandActive - Recruiting
Research Site
Wroclaw, 53-413
PolandSite Not Available
Research Site
Łódź, 93-338
PolandActive - Recruiting
Research Site
Singapore, 168583
SingaporeActive - Recruiting
Research Site
Barcelona, 8035
SpainActive - Recruiting
Research Site
Granada, 18016
SpainActive - Recruiting
Research Site
Hospitalet deLlobregat, 08907
SpainActive - Recruiting
Research Site
Madrid, 28034
SpainActive - Recruiting
Research Site
Santiago de Compostela, 15706
SpainActive - Recruiting
Research Site
Sevilla, 41009
SpainActive - Recruiting
Research Site
Zaragoza, 50009
SpainActive - Recruiting
Research Site
Baden, CH-5405
SwitzerlandActive - Recruiting
Research Site
Basel, 4031
SwitzerlandActive - Recruiting
Research Site
Bern, 3010
SwitzerlandActive - Recruiting
Research Site
Frauenfeld, 8501
SwitzerlandActive - Recruiting
Research Site
Rennaz, 1847
SwitzerlandSuspended
Research Site
Changhua, 500
TaiwanSite Not Available
Research Site
Kaohsiung, 82445
TaiwanSite Not Available
Research Site
Taichung, 40447
TaiwanSite Not Available
Research Site
Tainan, 704
TaiwanSite Not Available
Research Site
Taipei, 10449
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Bangkok, 10330
ThailandActive - Recruiting
Research Site
Dusit, 10300
ThailandActive - Recruiting
Research Site
Muang, 50200
ThailandActive - Recruiting
Research Site
Songkhla, 90110
ThailandActive - Recruiting
Research Site
Adapazari, 54290
TurkeyActive - Recruiting
Research Site
Ankara, 06010
TurkeyActive - Recruiting
Research Site
Istanbul, 34722
TurkeyActive - Recruiting
Research Site
Kayseri, 38039
TurkeyActive - Recruiting
Research Site
Samsun, 55200
TurkeyActive - Recruiting
Research Site
Birmingham, B15 2TG
United KingdomActive - Recruiting
Research Site
Cardiff, CF14 2TL
United KingdomActive - Recruiting
Research Site
Edinburgh, EH1 3EG
United KingdomActive - Recruiting
Research Site
Guildford,
United KingdomSite Not Available
Research Site
Lancaster, LA1 4RP
United KingdomActive - Recruiting
Research Site
London, EC1A 7BE
United KingdomActive - Recruiting
Research Site
Northampton, NN1 5BD
United KingdomActive - Recruiting
Research Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
Research Site
Taunton, TA1 5DA
United KingdomActive - Recruiting
Research Site
Daphne, Alabama 36526
United StatesActive - Recruiting
Research Site
Goodyear, Arizona 85395
United StatesActive - Recruiting
Research Site
Phoenix, Arizona 85054
United StatesSite Not Available
Research Site
Tucson, Arizona 85711
United StatesActive - Recruiting
Research Site
Jonesboro, Arkansas 72401
United StatesActive - Recruiting
Research Site
Rogers, Arkansas 72758
United StatesActive - Recruiting
Research Site
Bakersfield, California 93309
United StatesActive - Recruiting
Research Site
Fullerton, California 92835
United StatesActive - Recruiting
Research Site
Irvine, California 92612
United StatesSite Not Available
Research Site
Los Angeles, California 90033
United StatesActive - Recruiting
Research Site
Newport Beach, California 92663
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesActive - Recruiting
Research Site
Santa Barbara, California 93105
United StatesActive - Recruiting
Research Site
Santa Rosa, California 92805
United StatesActive - Recruiting
Research Site
Sylmar, California 91342
United StatesSite Not Available
Research Site
Torrance, California 90505
United StatesActive - Recruiting
Research Site
Van Nuys, California 91405
United StatesActive - Recruiting
Research Site
Aurora, Colorado 80045
United StatesActive - Recruiting
Research Site
Fort Collins, Colorado 80528
United StatesActive - Recruiting
Research Site
Longmont, Colorado 80504
United StatesActive - Recruiting
Research Site
Bridgeport, Connecticut 06606
United StatesActive - Recruiting
Research Site
New Haven, Connecticut 06510
United StatesActive - Recruiting
Research Site
Newark, Delaware 19713
United StatesSite Not Available
Research Site
Fort Myers, Florida 33901
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32224
United StatesSite Not Available
Research Site
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Research Site
Saint Petersburg, Florida 33705
United StatesActive - Recruiting
Research Site
Tallahassee, Florida 32308
United StatesSite Not Available
Research Site
West Palm Beach, Florida 33401
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30342
United StatesActive - Recruiting
Research Site
Chicago Ridge, Illinois 60415
United StatesActive - Recruiting
Research Site
Dyer, Indiana 46311
United StatesSite Not Available
Research Site
Des Moines, Iowa 50309
United StatesActive - Recruiting
Research Site
Edgewood, Kentucky 41017
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Research Site
Baton Rouge, Louisiana 70817
United StatesActive - Recruiting
Research Site
Annapolis, Maryland 21401
United StatesActive - Recruiting
Research Site
Bethesda, Maryland 20817
United StatesSite Not Available
Research Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
Research Site
Detroit, Michigan 48202
United StatesActive - Recruiting
Research Site
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Research Site
Traverse City, Michigan 49684
United StatesActive - Recruiting
Research Site
Burnsville, Minnesota 55337
United StatesActive - Recruiting
Research Site
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Research Site
Columbia, Missouri 65212
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
Omaha, Nebraska 68130
United StatesActive - Recruiting
Research Site
Henderson, Nevada 89074
United StatesActive - Recruiting
Research Site
Camden, New Jersey 08103
United StatesActive - Recruiting
Research Site
East Brunswick, New Jersey 08816
United StatesActive - Recruiting
Research Site
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Research Site
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Research Site
Commack, New York 11725
United StatesSite Not Available
Research Site
New York, New York 10065
United StatesActive - Recruiting
Research Site
Port Jefferson Station, New York 11776
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Research Site
Durham, North Carolina 27710
United StatesActive - Recruiting
Research Site
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Research Site
Blue Ash, Ohio 45242
United StatesActive - Recruiting
Research Site
Canton, Ohio 44710
United StatesActive - Recruiting
Research Site
Eugene, Oregon 97401
United StatesActive - Recruiting
Research Site
Portland, Oregon 97223
United StatesActive - Recruiting
Research Site
Horsham, Pennsylvania 19044
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Research Site
Providence, Rhode Island 02903
United StatesSite Not Available
Research Site
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Austin, Texas 78731
United StatesActive - Recruiting
Research Site
Dallas, Texas 75235
United StatesActive - Recruiting
Research Site
El Paso, Texas 79902
United StatesActive - Recruiting
Research Site
Flower Mound, Texas 75028
United StatesActive - Recruiting
Research Site
Fort Worth, Texas 76104
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Irving, Texas 75063
United StatesSite Not Available
Research Site
San Antonio, Texas 78240
United StatesActive - Recruiting
Research Site
Webster, Texas 77598
United StatesActive - Recruiting
Research Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
Research Site
Falls Church, Virginia 22042
United StatesSite Not Available
Research Site
Norfolk, Virginia 23502
United StatesActive - Recruiting
Research Site
Richmond, Virginia 23298
United StatesSite Not Available
Research Site
Roanoke, Virginia 24014
United StatesActive - Recruiting
Research Site
Winchester, Virginia 22601
United StatesActive - Recruiting
Research Site
Tacoma, Washington 98405
United StatesActive - Recruiting
Research Site
Madison, Wisconsin 53715
United StatesSite Not Available
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh city, 700000
VietnamActive - Recruiting
Research Site
Vinh, 460000
VietnamActive - Recruiting
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