A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
1 other identifier
interventional
625
24 countries
316
Brief Summary
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Nov 2023
Typical duration for phase_3 breast-cancer
316 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
November 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
April 30, 2026
April 1, 2026
3.7 years
October 23, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits. The measure of interest is the HR of PFS.
From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).
Secondary Outcomes (15)
Overall Survival (OS)
From randomisation until the date of death due to any cause (anticipated to be up to 64 months).
Objective Response Rate (ORR)
From randomisation up until progression (anticipated to be up to 33 months).
Duration of Response (DoR)
From the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 33 months).
Progression-Free Survival (PFS) by Investigator assessment
From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 33 months).
Clinical Benefit Rate (CBR) at 24 weeks
From randomisation up until progression, or the last evaluable assessment in the absence of progression (anticipated to be up to 33 months).
- +10 more secondary outcomes
Study Arms (3)
Dato-DXd + durvalumab
EXPERIMENTALArm 1: Dato-DXd + durvalumab
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
ACTIVE COMPARATORArm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)
Dato-DXd
EXPERIMENTALArm 3: Dato-DXd
Interventions
Provided in 500mg vials. IV infusion. Experimental drug.
IV infusion. Active comparator.
IV infusion. Active comparator.
IV infusion. Active comparator.
Provided in 100mg vials. IV infusion. Experimental drug.
IV infusion. Active comparator.
IV infusion. Active comparator.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
- ECOG PS 0 or 1.
- Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start).
- PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.
- No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
- \- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.
- Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
- Measurable disease as per RECIST 1.1.
- Adequate bone marrow reserve and organ function.
- Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.
You may not qualify if:
- As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.
- Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.
- \- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
- Active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled.
- Uncontrolled or significant cardiac disease.
- History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Clinically severe pulmonary function compromise.
- Clinically significant corneal disease.
- Active or prior documented autoimmune or inflammatory disorders.
- Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
- Any concurrent anti-cancer treatment.
- Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (316)
Research Site
Daphne, Alabama, 36526, United States
Research Site
Springdale, Arkansas, 72762, United States
Research Site
Duarte, California, 91010, United States
Research Site
Glendale, California, 91204, United States
Research Site
Sacramento, California, 95817, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
Aurora, Colorado, 80012, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
Jacksonville, Florida, 32256, United States
Research Site
Miami, Florida, 33176, United States
Research Site
Palm Bay, Florida, 32909, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Atlanta, Georgia, 30318, United States
Research Site
Honolulu, Hawaii, 96819, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Decatur, Illinois, 62526, United States
Research Site
Elmhurst, Illinois, 60126, United States
Research Site
Naperville, Illinois, 60540, United States
Research Site
New Albany, Indiana, 47150, United States
Research Site
Des Moines, Iowa, 50309, United States
Research Site
Lexington, Kentucky, 40503, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Louisville, Kentucky, 40207, United States
Research Site
Baton Rouge, Louisiana, 70808, United States
Research Site
Baton Rouge, Louisiana, 70809, United States
Research Site
Baltimore, Maryland, 21215, United States
Research Site
Columbia, Maryland, 21044, United States
Research Site
Boston, Massachusetts, 02111, United States
Research Site
Worcester, Massachusetts, 01655, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Grand Rapids, Michigan, 49503, United States
Research Site
Saint Paul, Minnesota, 55109, United States
Research Site
Hattiesburg, Mississippi, 39401, United States
Research Site
St Louis, Missouri, 63129, United States
Research Site
Albuquerque, New Mexico, 87109, United States
Research Site
Albany, New York, 12206, United States
Research Site
New York, New York, 10065, United States
Research Site
Stony Brook, New York, 11794-7263, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Cincinnati, Ohio, 45245, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
York, Pennsylvania, 17403, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Chattanooga, Tennessee, 37404, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Dallas, Texas, 75230, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
El Paso, Texas, 79902, United States
Research Site
Flower Mound, Texas, 75028, United States
Research Site
Fort Worth, Texas, 76104, United States
Research Site
Houston, Texas, 77054, United States
Research Site
Houston, Texas, 77090, United States
Research Site
Houston, Texas, 77098, United States
Research Site
Kingwood, Texas, 77339, United States
Research Site
McKinney, Texas, 75071, United States
Research Site
Sugar Land, Texas, 77479, United States
Research Site
Charlottesville, Virginia, 22903, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Midlothian, Virginia, 23114, United States
Research Site
Norfolk, Virginia, 23502, United States
Research Site
Roanoke, Virginia, 24014, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
CABA, 1414, Argentina
Research Site
CABA, 1425, Argentina
Research Site
CABA, C1113AAE, Argentina
Research Site
CABA, C1425, Argentina
Research Site
Ciudad Autónoma Buenos Aires, C1430EFA, Argentina
Research Site
Ciudad de Buenos Aires, C1015ABO, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
San Nicolás de los Arroyos, B2900, Argentina
Research Site
Camperdown, 2050, Australia
Research Site
Darlinghurst, 2010, Australia
Research Site
Heidelberg, 3084, Australia
Research Site
Melbourne, 3000, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Waratah, 2298, Australia
Research Site
Barretos, 14784-400, Brazil
Research Site
Curitiba, 80730-150, Brazil
Research Site
Florianópolis, 88034-000, Brazil
Research Site
Goiânia, 74000-000, Brazil
Research Site
Itajaí, 88301-220, Brazil
Research Site
Porto Alegre, 90035-003, Brazil
Research Site
Recife, 52010-075, Brazil
Research Site
São Paulo, 01246-000, Brazil
Research Site
São Paulo, 01317-001, Brazil
Research Site
Teresina, 64049-200, Brazil
Research Site
Barrie, Ontario, L4M 6M2, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Greenfield Park, Quebec, J4V 2H1, Canada
Research Site
Montreal, Quebec, H2X 0A9, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Québec, Quebec, G1S 4L8, Canada
Research Site
Regina, Saskatchewan, S4T 7T1, Canada
Research Site
Saskatoon, Saskatchewan, S7N 4H4, Canada
Research Site
Anyang, 455000, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100142, China
Research Site
Bengbu, 233004, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610000, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400030, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, 510700, China
Research Site
Hangzhou, 310009, China
Research Site
Hangzhou, 310016, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230031, China
Research Site
Jinan, 250021, China
Research Site
Meizhou, 514031, China
Research Site
Nanchang, 330009, China
Research Site
Nanjing, 2100008, China
Research Site
Nanjing, 210009, China
Research Site
Nanning, 530021, China
Research Site
Shandong, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200080, China
Research Site
Shenyang, 110004, China
Research Site
Tianjin, 300000, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430079, China
Research Site
Xi'an, 710061, China
Research Site
Xiamen, 361003, China
Research Site
Xintai, 54031, China
Research Site
Xuzhou, 221009, China
Research Site
Zhanjiang, 524003, China
Research Site
Zhengzhou, 450008, China
Research Site
Zhengzhou, 450052, China
Research Site
Lille, 59000, France
Research Site
Lyon, 69373, France
Research Site
Montpellier, 34298, France
Research Site
Paris, 75020, France
Research Site
Saint-Herblain, 44805, France
Research Site
Toulouse, 31059, France
Research Site
Vandœuvre-lès-Nancy, 54511, France
Research Site
Villejuif, 94800, France
Research Site
Düsseldorf, 40479, Germany
Research Site
Essen, 45136, Germany
Research Site
Georgsmarienhütte, 49124, Germany
Research Site
Hamburg, 20357, Germany
Research Site
Hanover, 30625, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Heilbronn, 74078, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Shatin, 00000, Hong Kong
Research Site
Calicut, 673601, India
Research Site
Chennai, 600031, India
Research Site
Jaipur, 302004, India
Research Site
Kochi, 682027, India
Research Site
Kolkata, 700160, India
Research Site
Marg Jaipur, 302004, India
Research Site
Mohali, 160055, India
Research Site
Mysuru, 570017, India
Research Site
Nagpur, 440001, India
Research Site
Nashik, 422009, India
Research Site
New Delhi, 110075, India
Research Site
New Delhi, 11029, India
Research Site
Puducherry, 605006, India
Research Site
Surat, 395002, India
Research Site
Thiruvananthapuram, 695011, India
Research Site
Vadodara, 391760, India
Research Site
Visakhapatnam, 530053, India
Research Site
Bergamo, 24127, Italy
Research Site
Empoli, 50053, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20141, Italy
Research Site
Modena, 41124, Italy
Research Site
Naples, 80131, Italy
Research Site
Padova, 35128, Italy
Research Site
Reggio Emilia, 42123, Italy
Research Site
Roma, 00168, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Akashi-shi, 673-8558, Japan
Research Site
Bunkyō City, 113-8431, Japan
Research Site
Bunkyō City, 113-8677, Japan
Research Site
Chiba, 260-8717, Japan
Research Site
Chūōku, 104-0045, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Fukushima, 960-1295, Japan
Research Site
Gifu, 501-1194, Japan
Research Site
Hidaka-shi, 350-1298, Japan
Research Site
Hiroshima, 730-8518, Japan
Research Site
Hiroshima, 734-8551, Japan
Research Site
Isehara-shi, 259-1193, Japan
Research Site
Kamogawa-shi, 296-8602, Japan
Research Site
Kashiwa, 277-8577, Japan
Research Site
Kitaadachi-gun, 362-0806, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Kumamoto, 860-8556, Japan
Research Site
Kurume-shi, 830-0011, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Nagoya, 466-8560, Japan
Research Site
Nagoya, 467-8602, Japan
Research Site
Niigata, 951-8566, Japan
Research Site
Nishinomiya-shi, 663-8501, Japan
Research Site
Okayama, 700-8558, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Osakasayama-shi, 589-8511, Japan
Research Site
Ota-shi, 373-8550, Japan
Research Site
Sapporo, 003-0804, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Shinagawa-ku, 142-8666, Japan
Research Site
Shinjuku-ku, 160-0023, Japan
Research Site
Shinjuku-ku, 162-8655, Japan
Research Site
Tsu, 514-8507, Japan
Research Site
Tsukuba, 305-8577, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
CD Mexico, 04980, Mexico
Research Site
Guadalajara, 44638, Mexico
Research Site
Guadalajara, 44670, Mexico
Research Site
Mexico City, 0 3100, Mexico
Research Site
México, 04700, Mexico
Research Site
México, 6760, Mexico
Research Site
Tuxtla Gutiérrez, 29090, Mexico
Research Site
Bacolod, 6100, Philippines
Research Site
Cebu City, 6000, Philippines
Research Site
City of Muntinlupa, 1780, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Quezon City, 1112, Philippines
Research Site
San Juan City, 1502, Philippines
Research Site
Bialystok, 15-027, Poland
Research Site
Bydgoszcz, 85-796, Poland
Research Site
Gdansk, 80-952, Poland
Research Site
Gdynia, 81-519, Poland
Research Site
Konin, 62-500, Poland
Research Site
Krakow, 31-115, Poland
Research Site
Krakow, 31-501, Poland
Research Site
Legnica, 59-220, Poland
Research Site
Lodz, 90-302, Poland
Research Site
Lublin, 20-090, Poland
Research Site
Przemyśl, 37-700, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Wroclaw, 53-413, Poland
Research Site
Singapore, 119228, Singapore
Research Site
Singapore, 169610, Singapore
Research Site
Singapore, 217562, Singapore
Research Site
Singapore, 308433, Singapore
Research Site
Cape Town, 7570, South Africa
Research Site
Johannesburg, 2013, South Africa
Research Site
Johannesburg, 2193, South Africa
Research Site
Johannesburg, 2196, South Africa
Research Site
Paarl, 7646, South Africa
Research Site
Pretoria, 0081, South Africa
Research Site
Pretoria, 0081, South Africa
Research Site
Busan, 49241, South Korea
Research Site
Daegu, 41404, South Korea
Research Site
Goyang-si, 10408, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06273, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Barcelona, 08028, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Granada, 18016, Spain
Research Site
Hospitalet deLlobregat, 08907, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28034, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Santander, 39008, Spain
Research Site
Hsinchu, 300, Taiwan
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 10449, Taiwan
Research Site
Taipei, 11259, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Bangkok, 10210, Thailand
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Chiang Mai, 50200, Thailand
Research Site
Dusit, 10300, Thailand
Research Site
Khon Kaen, 40002, Thailand
Research Site
Songkhla, 90110, Thailand
Research Site
Ankara, 06520, Turkey (Türkiye)
Research Site
Ankara, 6200, Turkey (Türkiye)
Research Site
Besevler Ankara, Turkey (Türkiye)
Research Site
Istanbul, 34010, Turkey (Türkiye)
Research Site
Izmir, 35575, Turkey (Türkiye)
Research Site
Küçükçekmece, 34295, Turkey (Türkiye)
Research Site
Samsun, 55200, Turkey (Türkiye)
Research Site
Cardiff, CF14 2TL, United Kingdom
Research Site
Chelsea, SW3 6JJ, United Kingdom
Research Site
Leicester, Le5 4PW, United Kingdom
Research Site
Liverpool, L7 8YA, United Kingdom
Research Site
London, EC1A 7BE, United Kingdom
Research Site
London, SW17 0QT, United Kingdom
Research Site
Oxford, OX3 7LE, United Kingdom
Research Site
Surrey, GU2 7XX, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Research Site
Taunton, TA1 5DA, United Kingdom
Research Site
Da Nang, 550000, Vietnam
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Hồ Chí Minh, 700000, Vietnam
Research Site
Huế, 530000, Vietnam
Research Site
Viet Tri, 35000, Vietnam
Research Site
Vinh, 460000, Vietnam
Related Publications (1)
Schmid P, Oliveira M, O'Shaughnessy J, Cristofanilli M, Graff SL, Im SA, Loi S, Saji S, Wang S, Cescon DW, Hovey T, Nawrot A, Tse K, Vukovic P, Curigliano G. TROPION-Breast05: a randomized phase III study of Dato-DXd with or without durvalumab versus chemotherapy plus pembrolizumab in patients with PD-L1-high locally recurrent inoperable or metastatic triple-negative breast cancer. Ther Adv Med Oncol. 2025 Apr 17;17:17588359251327992. doi: 10.1177/17588359251327992. eCollection 2025.
PMID: 40297626DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 27, 2023
Study Start
November 23, 2023
Primary Completion (Estimated)
July 28, 2027
Study Completion (Estimated)
September 30, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.