Breast Cancer Clinical Trial

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

Summary

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.

View Full Description

Full Description

Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patients must be ≥18 years of age

Pathologically documented breast cancer that:

is advanced or metastatic
is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
Has protocol-defined adequate organ and bone marrow function
ECOG performance status 0 or 1

Key Exclusion Criteria:

Ineligible for any of the agents on the study.
Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study.
Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1134

Study ID:

NCT04784715

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 324 Locations for this study

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Phoenix Arizona, 85054, United States
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Tucson Arizona, 85711, United States
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Tucson Arizona, 85715, United States
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Springdale Arkansas, 72762, United States
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Duarte California, 91010, United States
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Glendale California, 91204, United States
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Longmont Colorado, 80501, United States
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Miami Florida, 33176, United States
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New Port Richey Florida, 34655, United States
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Arlington Heights Illinois, 60005, United States
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Louisville Kentucky, 40241, United States
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Silver Spring Maryland, 20904, United States
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Boston Massachusetts, 02215, United States
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Boston Massachusetts, 02215, United States
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Detroit Michigan, 48202, United States
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Minneapolis Minnesota, 55404, United States
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Jackson Mississippi, 39213, United States
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Morristown New Jersey, 07960, United States
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Summit New Jersey, 07901, United States
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Albany New York, 12206, United States
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New York New York, 10065, United States
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Port Jefferson Station New York, 11776, United States
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Portland Oregon, 97223, United States
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Chattanooga Tennessee, 37404, United States
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Germantown Tennessee, 38138, United States
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Austin Texas, 78731, United States
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Dallas Texas, 75203, United States
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Dallas Texas, 75246, United States
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Denton Texas, 76201, United States
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Houston Texas, 77030, United States
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Houston Texas, 77090, United States
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San Antonio Texas, 78240, United States
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Shenandoah Texas, 77380, United States
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Tyler Texas, 75702, United States
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Norfolk Virginia, 23502, United States
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Roanoke Virginia, 24014, United States
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Seattle Washington, 98104, United States
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Caba , 1414, Argentina
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Caba , C1012, Argentina
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Caba , C1118, Argentina
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Capital Federal , C1417, Argentina
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Cipolletti , 8234, Argentina
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Ciudad Autonoma De Buenos Aire , C1125, Argentina
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Ciudad de Buenos Aires , 1280, Argentina
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La Plata , 1900, Argentina
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Mar del Plata , 7600, Argentina
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Rosario , S2000, Argentina
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Rosario , S2002, Argentina
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San Salvador de Jujuy , 4600, Argentina
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Innsbruck , 6020, Austria
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Wien , 1090, Austria
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Brussels , 1160, Belgium
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Bruxelles , 1200, Belgium
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Charleroi , 6000, Belgium
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Edegem , 2650, Belgium
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Liège , 4000, Belgium
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Namur , 5000, Belgium
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Barretos , 14784, Brazil
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Brasília , 70200, Brazil
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Florianópolis , 88034, Brazil
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Goiânia , 74000, Brazil
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Londrina , 86015, Brazil
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Natal , 59075, Brazil
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Porto Alegre , 90035, Brazil
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Ribeirão Preto , 14015, Brazil
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Sorocaba , 18030, Brazil
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São Paulo , 03102, Brazil
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Vitoria , 29043, Brazil
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Calgary Alberta, T2N 4, Canada
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Halifax Nova Scotia, B3H 2, Canada
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Kitchener Ontario, N2G 1, Canada
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Newmarket Ontario, L3Y 2, Canada
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North York Ontario, M2K 1, Canada
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Toronto Ontario, M5G 1, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H2X 3, Canada
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Montreal Quebec, H3T 1, Canada
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Montreal Quebec, H4A 3, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Beijing , 10003, China
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Beijing , 10004, China
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Beijing , 10019, China
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Changchun , 13002, China
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Changsha , 41000, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Chongqing , 40001, China
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Chongqing , 40003, China
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Chongqing , 40003, China
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Dalian , 11601, China
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Guangzhou , 51006, China
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Guangzhou , 51008, China
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Guangzhou , 51012, China
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Guiyang , 55000, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Harbin , 15004, China
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Hefei , 23002, China
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Kunming , 65011, China
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Nanchang , 33000, China
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Nanjing , 21000, China
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Nanjing , 21002, China
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Nanning , 53002, China
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Qingdao , 26610, China
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Shanghai , 20000, China
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Shanghai , 20002, China
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Shanghai , 20003, China
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Shenyang , 11000, China
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Shenzhen , 51803, China
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Tianjin , 30006, China
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Wu Han , 43006, China
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Wuhan , 43002, China
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Wuhan , 43003, China
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Xi'an , 71000, China
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Xi'an , 71006, China
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Yinchuan , 75000, China
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Zhengzhou , 45000, China
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Aalborg , 9000, Denmark
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Copenhagen O , 2100, Denmark
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Odense C , 5000, Denmark
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Sønderborg , 6400, Denmark
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Vejle , 7100, Denmark
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Avignon , 84000, France
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Besancon , 25000, France
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Bordeaux , 33030, France
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Caen Cedex , 14076, France
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Le Mans , 72000, France
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Montpellier , 34070, France
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Montpellier , 34298, France
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Nice Cedex 2 , 06189, France
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Paris , 75005, France
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Pierre Benite Cedex , 69495, France
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Rennes , 35042, France
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Saint Cloud , 92210, France
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Saint Herblain , 44805, France
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Toulouse Cedex 9 , 31059, France
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Vandoeuvre les Nancy , 54519, France
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Berlin , 10117, Germany
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Berlin , 13125, Germany
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Bonn , 53111, Germany
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Dresden , 1307, Germany
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Erlangen , 91054, Germany
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Essen , 45136, Germany
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Essen , 45147, Germany
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Frankfurt am Main , 60431, Germany
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Frankfurt , 60590, Germany
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Freiburg , 79110, Germany
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Hamburg , 20357, Germany
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Heidelberg , 69120, Germany
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Kiel , 24105, Germany
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Koblenz Am Rhein , 56068, Germany
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Leipzig , 04103, Germany
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Mainz Am Rhein , 55131, Germany
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Mannheim , 68167, Germany
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Muenster , 48149, Germany
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Neu-Isenburg , 63263, Germany
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Paderborn , 33161, Germany
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Rostock , 18059, Germany
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Troisdorf , 53840, Germany
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Budapest , 1062, Hungary
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Budapest , 1115, Hungary
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Budapest , 1122, Hungary
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Budapest , 1145, Hungary
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Győr , 9024, Hungary
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Kecskemét , 6000, Hungary
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Miskolc , 3526, Hungary
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Nyíregyháza , 4400, Hungary
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Szolnok , 5004, Hungary
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Ahmedabad , 38006, India
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Bangalore , 56002, India
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Belagavi , 59001, India
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Bengaluru , 56009, India
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Calicut , 67360, India
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Gurgaon , 12200, India
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Mysuru , 57001, India
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Nashik , 42200, India
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Nashik , 42201, India
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New Delhi , 11007, India
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New Delhi , 11008, India
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Petah Tikva , 49414, Israel
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Ramat Gan , , Israel
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Tel-Aviv , 64239, Israel
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Aviano , 33081, Italy
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Bergamo , 24127, Italy
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Candiolo , 10060, Italy
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Genova , 16132, Italy
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Livorno , 57100, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Rozzano , 20089, Italy
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Udine , 33100, Italy
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Akashi-shi , 673-8, Japan
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Bunkyo-ku , 113-8, Japan
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Chiba-shi , 260-8, Japan
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Chuo-ku , 104-0, Japan
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Fukushima-shi , 960-1, Japan
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Hidaka-shi , 350-1, Japan
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Hiroshima-shi , 730-8, Japan
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Hiroshima-shi , 734-8, Japan
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Isehara-shi , 259-1, Japan
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Kagoshima-shi , 892-0, Japan
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Kawasaki-shi , 216-8, Japan
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Kobe-shi , 650-0, Japan
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Koto-ku , 135-8, Japan
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Kurume-shi , 830-0, Japan
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Kyoto-shi , 606-8, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 467-0, Japan
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Niigata-shi , 951-8, Japan
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Nishinomiya-shi , 663-8, Japan
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Okayama , 700-8, Japan
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Osaka-shi , 541-8, Japan
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Ota-shi , 373-8, Japan
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Sapporo-shi , 003-0, Japan
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Sendai-shi , 980-8, Japan
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Shinagawa-ku , 142-8, Japan
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Shinjuku-ku , 160-0, Japan
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Shinjuku-ku , 162-8, Japan
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Shizuoka , 420-8, Japan
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Yokohama-shi , 241-8, Japan
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Cheonan-si , 31151, Korea, Republic of
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Daegu , 41404, Korea, Republic of
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Goyang-si , 410-7, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 08308, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Acapulco , 39670, Mexico
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Alc. Cuauhtémoc , 06700, Mexico
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Del. Cuauhtemoc , 06700, Mexico
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Estado de México , 50080, Mexico
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Guadalajara Jalisco , 44280, Mexico
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Guadalajara , 44680, Mexico
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Metepec , 52140, Mexico
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Mexico , 6760, Mexico
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MEX , 14080, Mexico
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Nuevo Leon , 66278, Mexico
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Arequipa , AREQU, Peru
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Lima , 15033, Peru
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Lima , 15036, Peru
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Lima , L27, Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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Baguio City , 2600, Philippines
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Cebu City , 6000, Philippines
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Davao City , 8000, Philippines
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Iloilo City , 5000, Philippines
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Manila , 1000, Philippines
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Quezon City , 1112, Philippines
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San Juan , 1500, Philippines
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Bucharest , 01146, Romania
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Bucuresti , 01117, Romania
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Cluj-Napoca , 40001, Romania
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Cluj-Napoca , 40001, Romania
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Constanta , 90059, Romania
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Floresti , 40728, Romania
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Iasi , 70048, Romania
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Timisoara , 30023, Romania
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Krasnodar , 35004, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 12120, Russian Federation
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Moscow , 12909, Russian Federation
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Moscow , 14344, Russian Federation
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Omsk , 64403, Russian Federation
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Saint Petersburg , 19002, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Yaroslavl , 15005, Russian Federation
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Dammam , 31444, Saudi Arabia
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Jeddah , 22384, Saudi Arabia
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Jeddah , 23214, Saudi Arabia
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Makkah , 24246, Saudi Arabia
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Riyadh , 11211, Saudi Arabia
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Riyadh , 11426, Saudi Arabia
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Riyadh , 11525, Saudi Arabia
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Riyadh , 12987, Saudi Arabia
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Cape Town , 7570, South Africa
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Cape Town , 7925, South Africa
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George , 6529, South Africa
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Johannesburg , 2196, South Africa
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Parktown , 2193, South Africa
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Port Elizabeth , 6045, South Africa
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Pretoria , 0081, South Africa
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Rondebosch , 7700, South Africa
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Soweto , 2013, South Africa
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Alicante , 03010, Spain
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Barcelona , 08028, Spain
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Barcelona , 08036, Spain
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Barcelona , 8035, Spain
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Madrid , 28005, Spain
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Madrid , 28041, Spain
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Madrid , 28046, Spain
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Majadahonda , 28222, Spain
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San Sebastian , 20014, Spain
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Sevilla , 41009, Spain
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Göteborg , 413 4, Sweden
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Stockholm , 118 8, Sweden
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Uppsala , 75185, Sweden
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Växjö , 35185, Sweden
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Örebro , 701 8, Sweden
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Taichung , 40443, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 100, Taiwan
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Taipei , 10449, Taiwan
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Taipei , 11217, Taiwan
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Taipei , 235, Taiwan
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Taoyuan , 333, Taiwan
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Adana , 01330, Turkey
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Ankara , 06520, Turkey
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Ankara , , Turkey
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Karsiyaka , 35575, Turkey
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Malatya , 44280, Turkey
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Samsun , , Turkey
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Buckhurst Hill , IG9 5, United Kingdom
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Edinburgh , EH4 2, United Kingdom
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Guildford , GU2 7, United Kingdom
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London , NW1 2, United Kingdom
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London , NW3 2, United Kingdom
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Maidstone , ME16 , United Kingdom
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Manchester , M20 4, United Kingdom
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Swansea , SA2 8, United Kingdom
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Taunton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1134

Study ID:

NCT04784715

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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