Breast CancerPhase 3NCT06103864
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 (TROPION-Breast05)
A Phase 3 study testing Dato-DXd, Durvalumab and Paclitaxel in people with Breast Cancer, run by AstraZeneca at 318 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dato-DXd, Durvalumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 318 sitesin 24 countries
- Study dates
- 23 Nov 2023to 30 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
Trial locations and contacts
318 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
318 sites in 24 countries
United States67 sites, 36 recruiting
- Withdrawn
Research Site
Albany, New York, 12206
- Recruiting
Research Site
Albuquerque, New Mexico, 87109
- Not yet recruiting
Research Site
Altamonte Springs, Florida, 32701
- Suspended
Research Site
Atlanta, Georgia, 30318
- Recruiting
Research Site
Aurora, Colorado, 80012
- Withdrawn
Research Site
Baltimore, Maryland, 21215
- Withdrawn
Research Site
Baton Rouge, Louisiana, 70808
- Recruiting
Research Site
Baton Rouge, Louisiana, 70809
- Withdrawn
Research Site
Boston, Massachusetts, 02111
- Recruiting
Research Site
Charlottesville, Virginia, 22903
- Recruiting
Research Site
Chattanooga, Tennessee, 37404
- Recruiting
Research Site
Chicago, Illinois, 60637
- Recruiting
Research Site
Cincinnati, Ohio, 45219
- Recruiting
Research Site
Cincinnati, Ohio, 45245
- Recruiting
Research Site
Cleveland, Ohio, 44195
- Recruiting
Research Site
Columbia, Maryland, 21044
- Withdrawn
Research Site
Dallas, Texas, 75230
- Recruiting
Research Site
Dallas, Texas, 75246
- Withdrawn
Research Site
Dallas, Texas, 75246
- Recruiting
Research Site
Daphne, Alabama, 36526
- Withdrawn
Research Site
Decatur, Illinois, 62526
- Not yet recruiting
Research Site
Denver, Colorado, 80210
- Recruiting
Research Site
Des Moines, Iowa, 50309
- Recruiting
Research Site
Detroit, Michigan, 48201
- Withdrawn
Research Site
Duarte, California, 91010
- Recruiting
Research Site
El Paso, Texas, 79902
- Withdrawn
Research Site
Elmhurst, Illinois, 60126
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Withdrawn
Research Site
Flower Mound, Texas, 75028
- Withdrawn
Research Site
Fort Worth, Texas, 76104
- Not yet recruiting
Research Site
Fountain Valley, California, 92708
- Recruiting
Research Site
Glendale, California, 91204
- Withdrawn
Research Site
Grand Rapids, Michigan, 49503
- Withdrawn
Research Site
Hattiesburg, Mississippi, 39401
- Withdrawn
Research Site
Honolulu, Hawaii, 96819
- Withdrawn
Research Site
Houston, Texas, 77054
- Withdrawn
Research Site
Houston, Texas, 77090
- Withdrawn
Research Site
Houston, Texas, 77098
- Withdrawn
Research Site
Jacksonville, Florida, 32256
- Withdrawn
Research Site
Kingwood, Texas, 77339
- Withdrawn
Research Site
Lexington, Kentucky, 40503
- Withdrawn
Research Site
Louisville, Kentucky, 40202
- Withdrawn
Research Site
Louisville, Kentucky, 40207
- Withdrawn
Research Site
Madison, Wisconsin, 53792
- Withdrawn
Research Site
McKinney, Texas, 75071
- Recruiting
Research Site
Miami, Florida, 33176
- Recruiting
Research Site
Midlothian, Virginia, 23114
- Withdrawn
Research Site
Naperville, Illinois, 60540
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Withdrawn
Research Site
New Albany, Indiana, 47150
- Recruiting
Research Site
New Haven, Connecticut, 06510
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Norfolk, Virginia, 23502
- Withdrawn
Research Site
Palm Bay, Florida, 32909
- Recruiting
Research Site
Plantation, Florida, 33324
- Recruiting
Research Site
Providence, Rhode Island, 02903
- Recruiting
Research Site
Roanoke, Virginia, 24014
- Recruiting
Research Site
Sacramento, California, 95817
- Recruiting
Research Site
Saint Paul, Minnesota, 55109
- Withdrawn
Research Site
Santa Rosa, California, 95403
- Recruiting
Research Site
Springdale, Arkansas, 72762
- Recruiting
Research Site
St Louis, Missouri, 63129
- Recruiting
Research Site
Stony Brook, New York, 11794-7263
- Recruiting
Research Site
Sugar Land, Texas, 77479
- Recruiting
Research Site
Tacoma, Washington, 98405
- Withdrawn
Research Site
Worcester, Massachusetts, 01655
- Withdrawn
Research Site
York, Pennsylvania, 17403
China41 sites, 38 recruiting
- Recruiting
Research Site
Anyang, 455000
- Recruiting
Research Site
Beijing, 100044
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Bengbu, 233004
- Recruiting
Research Site
Changchun, 130021
- Recruiting
Research Site
Changsha, 410008
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chengdu, 610000
- Recruiting
Research Site
Chengdu, 610041
- Withdrawn
Research Site
Chongqing, 400030
- Recruiting
Research Site
Fuzhou, 350014
- Recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Guangzhou, 510120
- Recruiting
Research Site
Guangzhou, 510700
- Recruiting
Research Site
Hangzhou, 310009
- Recruiting
Research Site
Hangzhou, 310016
- Recruiting
Research Site
Hangzhou, 310022
- Recruiting
Research Site
Harbin, 150081
- Recruiting
Research Site
Hefei, 230031
- Active, not recruiting
Research Site
Jinan, 250021
- Recruiting
Research Site
Meizhou, 514031
- Recruiting
Research Site
Nanchang, 330009
- Recruiting
Research Site
Nanjing, 2100008
- Recruiting
Research Site
Nanjing, 210009
- Recruiting
Research Site
Nanning, 530021
- Recruiting
Research Site
Shandong
- Recruiting
Research Site
Shanghai, 200025
- Completed
Research Site
Shanghai, 200080
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Taiyuan, 030000
- Recruiting
Research Site
Tianjin, 300000
- Recruiting
Research Site
Wenzhou, 325000
- Recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhan, 430079
- Recruiting
Research Site
Xi'an, 710061
- Recruiting
Research Site
Xiamen, 361003
- Recruiting
Research Site
Xintai, 54031
- Recruiting
Research Site
Xuzhou, 221009
- Recruiting
Research Site
Zhanjiang, 524003
- Recruiting
Research Site
Zhengzhou, 450008
- Recruiting
Research Site
Zhengzhou, 450052
Japan35 sites, 35 recruiting
- Recruiting
Research Site
Akashi-shi, 673-8558
- Recruiting
Research Site
Bunkyō City, 113-8431
- Recruiting
Research Site
Bunkyō City, 113-8677
- Recruiting
Research Site
Chiba, 260-8717
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Fukuoka, 811-1395
- Recruiting
Research Site
Fukushima, 960-1295
- Recruiting
Research Site
Gifu, 501-1194
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Recruiting
Research Site
Hiroshima, 730-8518
- Recruiting
Research Site
Hiroshima, 734-8551
- Recruiting
Research Site
Isehara-shi, 259-1193
- Recruiting
Research Site
Kamogawa-shi, 296-8602
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Kitaadachi-gun, 362-0806
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Kumamoto, 860-8556
- Recruiting
Research Site
Kurume-shi, 830-0011
- Recruiting
Research Site
Matsuyama, 791-0280
- Recruiting
Research Site
Nagoya, 466-8560
- Recruiting
Research Site
Nagoya, 467-8602
- Recruiting
Research Site
Niigata, 951-8566
- Recruiting
Research Site
Nishinomiya-shi, 663-8501
- Recruiting
Research Site
Okayama, 700-8558
- Recruiting
Research Site
Osaka, 541-8567
- Recruiting
Research Site
Osakasayama-shi, 589-8511
- Recruiting
Research Site
Ota-shi, 373-8550
- Recruiting
Research Site
Sapporo, 003-0804
- Recruiting
Research Site
Sendai, 980-8574
- Recruiting
Research Site
Shinagawa-ku, 142-8666
- Recruiting
Research Site
Shinjuku-ku, 160-0023
- Recruiting
Research Site
Shinjuku-ku, 162-8655
- Recruiting
Research Site
Tsu, 514-8507
- Recruiting
Research Site
Tsukuba, 305-8577
- Recruiting
Research Site
Yokohama, 241-8515
India18 sites, 13 recruiting
- Withdrawn
Research Site
Calicut, 673601
- Recruiting
Research Site
Chennai, 600031
- Withdrawn
Research Site
Jaipur, 302004
- Withdrawn
Research Site
Kochi, 682027
- Withdrawn
Research Site
Kolkata, 700160
- Recruiting
Research Site
Kottayam, 686008
- Recruiting
Research Site
Marg Jaipur, 302004
- Recruiting
Research Site
Mohali, 160055
- Recruiting
Research Site
Mysuru, 570017
- Recruiting
Research Site
Nagpur, 440001
- Recruiting
Research Site
Nashik, 422009
- Recruiting
Research Site
New Delhi, 110075
- Recruiting
Research Site
New Delhi, 11029
- Recruiting
Research Site
Puducherry, 605006
- Recruiting
Research Site
Surat, 395002
- Recruiting
Research Site
Thiruvananthapuram, 695011
- Recruiting
Research Site
Vadodara, 391760
- Withdrawn
Research Site
Visakhapatnam, 530053
Poland13 sites, 4 recruiting
- Withdrawn
Research Site
Bialystok, 15-027
- Withdrawn
Research Site
Bydgoszcz, 85-796
- Recruiting
Research Site
Gdansk, 80-952
- Withdrawn
Research Site
Gdynia, 81-519
- Withdrawn
Research Site
Konin, 62-500
- Withdrawn
Research Site
Krakow, 31-115
- Recruiting
Research Site
Krakow, 31-501
- Withdrawn
Research Site
Legnica, 59-220
- Recruiting
Research Site
Lodz, 90-302
- Withdrawn
Research Site
Lublin, 20-090
- Withdrawn
Research Site
Przemyśl, 37-700
- Recruiting
Research Site
Warsaw, 02-781
- Withdrawn
Research Site
Wroclaw, 53-413
South Korea11 sites, 10 recruiting
- Completed
Research Site
Busan, 49241
- Recruiting
Research Site
Daegu, 41404
- Recruiting
Research Site
Goyang-si, 10408
- Recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 02841
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 06273
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 06591
Brazil10 sites, 10 recruiting
- Recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Curitiba, 80730-150
- Recruiting
Research Site
Florianópolis, 88034-000
- Recruiting
Research Site
Goiânia, 74000-000
- Recruiting
Research Site
Itajaí, 88301-220
- Recruiting
Research Site
Porto Alegre, 90035-003
- Recruiting
Research Site
Recife, 52010-075
- Recruiting
Research Site
São Paulo, 01246-000
- Recruiting
Research Site
São Paulo, 01317-001
- Recruiting
Research Site
Teresina, 64049-200
Italy10 sites, 9 recruiting
- Recruiting
Research Site
Bergamo, 24127
- Recruiting
Research Site
Empoli, 50053
- Recruiting
Research Site
Milan, 20132
- Recruiting
Research Site
Milan, 20141
- Withdrawn
Research Site
Modena, 41124
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Padova, 35128
- Recruiting
Research Site
Reggio Emilia, 42123
- Recruiting
Research Site
Roma, 00168
- Recruiting
Research Site
Rozzano, 20089
United Kingdom10 sites, 6 recruiting
- Recruiting
Research Site
Cardiff, CF14 2TL
- Recruiting
Research Site
Chelsea, SW3 6JJ
- Recruiting
Research Site
Leicester, Le5 4PW
- Terminated
Research Site
Liverpool, L7 8YA
- Recruiting
Research Site
London, EC1A 7BE
- Withdrawn
Research Site
London, SW17 0QT
- Suspended
Research Site
Oxford, OX3 7LE
- Suspended
Research Site
Surrey, GU2 7XX
- Recruiting
Research Site
Sutton, SM2 5PT
- Recruiting
Research Site
Taunton, TA1 5DA
Canada9 sites, 9 recruiting
- Recruiting
Research Site
Barrie, Ontario, L4M 6M2
- Recruiting
Research Site
Greenfield Park, Quebec, J4V 2H1
- Recruiting
Research Site
Hamilton, Ontario, L8V 5C2
- Recruiting
Research Site
Montreal, Quebec, H2X 0A9
- Recruiting
Research Site
Montreal, Quebec, H4A 3J1
- Recruiting
Research Site
Québec, Quebec, G1S 4L8
- Recruiting
Research Site
Regina, Saskatchewan, S4T 7T1
- Recruiting
Research Site
Saskatoon, Saskatchewan, S7N 4H4
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
Taiwan9 sites, 9 recruiting
- Recruiting
Research Site
Hsinchu, 300
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei, 100
- Recruiting
Research Site
Taipei, 10449
- Recruiting
Research Site
Taipei, 11259
- Recruiting
Research Site
Taipei, 112
- Recruiting
Research Site
Taoyuan, 333
Argentina8 sites, 6 recruiting
- Recruiting
Research Site
CABA, 1414
- Recruiting
Research Site
CABA, 1425
- Recruiting
Research Site
CABA, C1113AAE
- Withdrawn
Research Site
CABA, C1425
- Recruiting
Research Site
Ciudad Autónoma Buenos Aires, C1430EFA
- Recruiting
Research Site
Ciudad de Buenos Aires, C1015ABO
- Recruiting
Research Site
Rosario, 2000
- Withdrawn
Research Site
San Nicolás de los Arroyos, B2900
France8 sites, 8 recruiting
- Recruiting
Research Site
Lille, 59000
- Recruiting
Research Site
Lyon, 69373
- Recruiting
Research Site
Montpellier, 34298
- Recruiting
Research Site
Paris, 75020
- Recruiting
Research Site
Saint-Herblain, 44805
- Recruiting
Research Site
Toulouse, 31059
- Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
- Recruiting
Research Site
Villejuif, 94800
Germany8 sites
- Withdrawn
Research Site
Düsseldorf, 40479
- Withdrawn
Research Site
Essen, 45136
- Withdrawn
Research Site
Georgsmarienhütte, 49124
- Withdrawn
Research Site
Hamburg, 20357
- Withdrawn
Research Site
Hanover, 30625
- Withdrawn
Research Site
Heidelberg, 69120
- Withdrawn
Research Site
Heilbronn, 74078
- Withdrawn
Research Site
Leipzig, 04103
Spain8 sites, 6 recruiting
- Withdrawn
Research Site
Barcelona, 08028
- Recruiting
Research Site
Barcelona, 8035
- Recruiting
Research Site
Granada, 18016
- Recruiting
Research Site
Hospitalet deLlobregat, 08907
- Recruiting
Research Site
Madrid, 28007
- Withdrawn
Research Site
Madrid, 28034
- Recruiting
Research Site
Pamplona, 31008
- Recruiting
Research Site
Santander, 39008
Thailand8 sites, 8 recruiting
- Recruiting
Research Site
Bangkok, 10210
- Recruiting
Research Site
Bangkok, 10330
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Chiang Mai, 50200
- Recruiting
Research Site
Dusit, 10300
- Recruiting
Research Site
Khon Kaen, 40002
- Recruiting
Research Site
Songkhla, 90110
Mexico7 sites, 6 recruiting
- Recruiting
Research Site
CD Mexico, 04980
- Recruiting
Research Site
Guadalajara, 44638
- Withdrawn
Research Site
Guadalajara, 44670
- Recruiting
Research Site
México, 04700
- Recruiting
Research Site
Mexico City, 0 3100
- Recruiting
Research Site
Mexico City, 06760
- Recruiting
Research Site
Tuxtla Gutiérrez, 29090
South Africa7 sites, 6 recruiting
- Recruiting
Research Site
Cape Town, 7570
- Recruiting
Research Site
Johannesburg, 2013
- Recruiting
Research Site
Johannesburg, 2193
- Recruiting
Research Site
Johannesburg, 2196
- Recruiting
Research Site
Paarl, 7646
- Completed
Research Site
Pretoria, 0081
- Recruiting
Research Site
Pretoria, 0081
Turkey (Türkiye)7 sites, 6 recruiting
- Recruiting
Research Site
Ankara, 06520
- Recruiting
Research Site
Ankara, 6200
- Recruiting
Research Site
Besevler Ankara
- Recruiting
Research Site
Istanbul, 34010
- Withdrawn
Research Site
Izmir, 35575
- Recruiting
Research Site
Küçükçekmece, 34295
- Recruiting
Research Site
Samsun, 55200
Vietnam7 sites, 7 recruiting
- Recruiting
Research Site
Da Nang, 550000
- Recruiting
Research Site
Hanoi, 100000
- Recruiting
Research Site
Hồ Chí Minh, 700000
- Recruiting
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Huế, 530000
- Recruiting
Research Site
Viet Tri, 35000
- Recruiting
Research Site
Vinh, 460000
Australia6 sites, 3 recruiting
- Recruiting
Research Site
Camperdown, 2050
- Completed
Research Site
Darlinghurst, 2010
- Completed
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Melbourne, 3000
- Recruiting
Research Site
Nedlands, 6009
- Withdrawn
Research Site
Waratah, 2298
Philippines6 sites, 6 recruiting
- Recruiting
Research Site
Bacolod, 6100
- Recruiting
Research Site
Cebu City, 6000
- Recruiting
Research Site
City of Muntinlupa, 1780
- Recruiting
Research Site
Manila, 1000
- Recruiting
Research Site
Quezon City, 1112
- Recruiting
Research Site
San Juan City, 1502
Singapore4 sites, 3 recruiting
- Withdrawn
Research Site
Singapore, 119228
- Recruiting
Research Site
Singapore, 169610
- Recruiting
Research Site
Singapore, 217562
- Recruiting
Research Site
Singapore, 308433
About this study
Official title: 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)
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.
Read the detailed description
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no).
This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
- Conditions
- Breast Cancer
- Being tested
- Dato-DXd, Durvalumab, Paclitaxel, Nab-paclitaxel, Gemcitabine
- Keywords
- Breast Cancer, Triple-negative, Metastatic, Inoperable, Datopotamab deruxtecan, Dato-DXd, DS1062a, DS1062, Durvalumab, Paclitaxel, Nab-paclitaxel, Gemcitabine, Carboplatin, Pembrolizumab, PD-1/PD-L1 Therapy, TROP2, Antibody Drug Conjugate (ADC), Immune Checkpoint Inhibitor (ICI)
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dato-DXdDrug
Also called Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Provided in 100mg vials. IV infusion. Experimental drug.
DurvalumabDrug
Also called MEDI4736
Provided in 500mg vials. IV infusion. Experimental drug.
PaclitaxelDrug
IV infusion. Active comparator.
Nab-paclitaxelDrug
IV infusion. Active comparator.
GemcitabineDrug
IV infusion. Active comparator.
CarboplatinDrug
IV infusion. Active comparator.
PembrolizumabDrug
IV infusion. Active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Dato-DXd + durvalumab | Experimental | Arm 1: Dato-DXd + durvalumab Receives: Drug: Dato-DXd; Drug: Durvalumab |
| Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab | Active comparator | Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Pembrolizumab |
| Dato-DXd | Experimental | Arm 3: Dato-DXd Receives: Drug: Dato-DXd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: From randomisation until the date of death due to any cause (anticipated to be up to 64 months).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a CR or PR, as determined by the BICR/investigator assessment, per RECIST 1.1.
Measured: From randomisation up until progression (anticipated to be up to 33 months).
Duration of Response (DoR)
DoR is defined as the time 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.
Measured: 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
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.
Measured: 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
CBR at 24 weeks is defined as the percentage of participants who have a CR or PR or who have SD, per RECIST 1.1, as assessed by BICR/per investigator assessment and derived from the raw tumour data for at least 23 weeks after randomisation.
Measured: From randomisation up until progression, or the last evaluable assessment in the absence of progression (anticipated to be up to 33 months).
Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
TTD in breast symptoms and arm symptoms as measured by the arm symptoms scale from EORTC IL116 TTD is defined as time from the date of randomisation to the date of deterioration.
Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold.
Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in pain in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
TTD in pain as measured by the EORTC IL199.
Measured: Time from the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in physical functioning in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
TTD in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c.
Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
TTD in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172.
Measured: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to First Subsequent Therapy (TFST)
TFST is defined as the time from randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.
Measured: From randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 64 months).
Time to Second Subsequent Therapy (TSST)
TSST is defined as the time from randomisation until the start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
Measured: From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 64 months).
Progression Free Survival 2 (PFS2)
PFS2 will be defined as the time from the randomisation to the earliest progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice based on radiological or clinical progression.
Measured: From the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 64 months).
Pharmacokinetics of Dato-DXd in combination with durvalumab
Concentration of Dato-DXd, total anti-TROP2 antibody, and DXd (payload) in plasma.
Measured: From first dose to end of treatment (anticipated to be up to 33 months).
Immunogenicity of Dato-DXd in combination with durvalumab
Presence of antidrug antibodies for Dato-DXd (confirmatory results: positive or negative, titres).
Measured: From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Safety and tolerability of Dato-DXd + durvalumab as compared with ICC + pembrolizumab
Safety and tolerability will be evaluated in the safety population in terms of AEs.
Measured: From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start23 Nov 2023
- Primary completion28 Jul 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised either 1:1 to Arm 1 (Dato-DXd + durvalumab) and Arm 2 (ICC + pembrolizumab), or in selected countries, 1:1:1 to Arms 1, 2 and 3 (Dato-DXd monotherapy). Once approximately 75 participants are randomised to Arm 3, this cohort will close, and all countries will continue with a 1:1 randomisation strategy for Arms 1 and 2.
- Masking
- None (open label)
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103864
- Sponsor's protocol ID
- D7630C00001
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40297626
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06103864
- Acronym / sponsor ID
- D7630C00001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Triple-negative, Metastatic, Inoperable, Datopotamab deruxtecan, Dato-DXd, DS1062a, DS1062
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no).
This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomised either 1:1 to Arm 1 (Dato-DXd + durvalumab) and Arm 2 (ICC + pembrolizumab), or in selected countries, 1:1:1 to Arms 1, 2 and 3 (Dato-DXd monotherapy). Once approximately 75 participants are randomised to Arm 3, this cohort will close, and all countries will continue with a 1:1 randomisation strategy for Arms 1 and 2.
| Arm | Type | Receives |
|---|---|---|
| Dato-DXd + durvalumab | Experimental | Drug: Dato-DXd, Drug: DurvalumabArm 1: Dato-DXd + durvalumab |
| Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab | Active comparator | Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Carboplatin, Drug: PembrolizumabArm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) |
| Dato-DXd | Experimental | Drug: Dato-DXdArm 3: Dato-DXd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
- Active or uncontrolled hepatitis B or C virus infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dato-DXdAlso: Datopotamab deruxtecan (Dato-DXd, DS-1062a)Provided in 100mg vials. IV infusion. Experimental drug. | Drug | Dato-DXd, Dato-DXd + durvalumab |
| DurvalumabAlso: MEDI4736Provided in 500mg vials. IV infusion. Experimental drug. | Drug | Dato-DXd + durvalumab |
| PaclitaxelIV infusion. Active comparator. | Drug | Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab |
| Nab-paclitaxelIV infusion. Active comparator. | Drug | Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab |
| GemcitabineIV infusion. Active comparator. | Drug | Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab |
| CarboplatinIV infusion. Active comparator. | Drug | Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab |
| PembrolizumabIV infusion. Active comparator. | Drug | Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab |
Primary outcome
Progression Free Survival (PFS)
Time frame: 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).
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.
15 secondary outcomes
Overall Survival (OS)
Time frame: From randomisation until the date of death due to any cause (anticipated to be up to 64 months).
Objective Response Rate (ORR)
Time frame: From randomisation up until progression (anticipated to be up to 33 months).
Duration of Response (DoR)
Time frame: 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
Time frame: 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
Time frame: From randomisation up until progression, or the last evaluable assessment in the absence of progression (anticipated to be up to 33 months).
Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Time frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in pain in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Time frame: Time from the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in physical functioning in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Time frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd + durvalumab compared with ICC + pembrolizumab
Time frame: From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression).
Time to First Subsequent Therapy (TFST)
Time frame: From randomisation until the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause (anticipated to be up to 64 months).
Time to Second Subsequent Therapy (TSST)
Time frame: From randomisation until the start date of the second subsequent anti cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (anticipated to be up to 64 months).
Progression Free Survival 2 (PFS2)
Time frame: From the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death (anticipated to be up to 64 months).
Pharmacokinetics of Dato-DXd in combination with durvalumab
Time frame: From first dose to end of treatment (anticipated to be up to 33 months).
Immunogenicity of Dato-DXd in combination with durvalumab
Time frame: From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Safety and tolerability of Dato-DXd + durvalumab as compared with ICC + pembrolizumab
Time frame: From first dose to end of treatment safety follow-up (anticipated to be up to 33 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 40297626Schmid 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.
- Breast Cancer Study Locator details (for US)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
318 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dato-DXd, Durvalumab and Paclitaxel in people with Breast Cancer, run by AstraZeneca at 318 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 318 sites in United States, China, Japan, India, Poland and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.