Trial Title:
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
NCT ID:
NCT06103864
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Durvalumab
Conditions: 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)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dato-DXd
Description:
Provided in 100mg vials. IV infusion. Experimental drug.
Arm group label:
Dato-DXd
Arm group label:
Dato-DXd + durvalumab
Other name:
Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Provided in 500mg vials. IV infusion. Experimental drug.
Arm group label:
Dato-DXd + durvalumab
Other name:
MEDI4736
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV infusion. Active comparator.
Arm group label:
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
IV infusion. Active comparator.
Arm group label:
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
IV infusion. Active comparator.
Arm group label:
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion. Active comparator.
Arm group label:
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
IV infusion. Active comparator.
Arm group label:
Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
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.
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria
- 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.
- All participants must provide a FFPE tumour sample (primary, metastatic (location
excluding bone), or locally recurrent inoperable tumour sample) collected ≤ 3 months
prior to signing of informed consent (ie, start of screening).
- 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 targeted 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.
Key Exclusion Criteria
- As judged by investigator, severe or uncontrolled medical conditions including
systemic diseases, history of allogeneic organ transplant and active bleeding
diseases, ongoing or active infection, significant cardiac or psychological
conditions.
- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease within 3 years before Cycle 1 Day 1 and of low
potential risk for recurrence.
- Neoplastic spinal cord compression or active brain metastases, leptomeningeal
carcinomatosis or history of leptomeningeal carcinomatosis.
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Daphne
Zip:
36526
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Glendale
Zip:
91204
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Palm Bay
Zip:
32909
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Atlanta
Zip:
30318
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Honolulu
Zip:
96819
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Elmhurst
Zip:
60126
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Naperville
Zip:
60540
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Albany
Zip:
47150
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Worcester
Zip:
01655
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Paul
Zip:
55109
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Albany
Zip:
12206
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Stony Brook
Zip:
11794-7263
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cincinnati
Zip:
45245
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
York
Zip:
17403
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chattanooga
Zip:
37404
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
El Paso
Zip:
79902
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Flower Mound
Zip:
75028
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77098
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kingwood
Zip:
77339
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
McKinney
Zip:
75071
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Sugar Land
Zip:
77479
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Midlothian
Zip:
23114
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Buenos Aires
Zip:
C1125ABD
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Caba
Zip:
1414
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Caba
Zip:
1425
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Caba
Zip:
C1425
Country:
Argentina
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Ciudad Autonoma Bs As
Zip:
C1015ABO
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Nicolas de Los Arroyos
Zip:
B2900
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Curitiba
Zip:
80730-150
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Goiânia
Zip:
74000-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Itajai
Zip:
88301-220
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90035-003
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Recife
Zip:
52010-075
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
01317-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Teresina
Zip:
64049-200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barrie
Zip:
L4M 6M2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Greenfield Park
Zip:
J4V 2H1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montréal
Zip:
H2X 0A9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Regina
Zip:
S4T 7T1
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saskatoon
Zip:
S7N 4H4
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Quebec
Zip:
G1S 4L8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bengbu
Zip:
233060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ji Nan
Zip:
250021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanchang
Zip:
330009
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
2100008
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Xintai
Zip:
54031
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xuzhou
Zip:
221009
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Herblain Cedex
Zip:
44805
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toulouse Cedex 9
Zip:
31059
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Düsseldorf
Zip:
40479
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Georgsmarienhütte
Zip:
49124
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
20357
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Heilbronn
Zip:
74078
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Calicut
Zip:
673601
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kochi
Zip:
682027
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kolkata
Zip:
700160
Country:
India
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Marg Jaipur
Zip:
302004
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mohali
Zip:
160055
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mysuru
Zip:
570017
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagpur
Zip:
440001
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashik
Zip:
422009
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New Delhi
Zip:
110075
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New Delhi
Zip:
11029
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pondicherry
Zip:
605006
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Surat
Zip:
395002
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vadodara
Zip:
391760
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vishakapatnam
Zip:
530053
Country:
India
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Empoli
Zip:
50053
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Modena
Zip:
41124
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Akashi-shi
Zip:
673-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bunkyo-ku
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bunkyo-ku
Zip:
113-8677
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fukuoka-shi
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukushima-shi
Zip:
960-1295
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gifu-shi
Zip:
501-1194
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hidaka-shi
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima-shi
Zip:
730-8518
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima-shi
Zip:
734-8551
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Isehara-shi
Zip:
259-1193
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kamogawa-shi
Zip:
296-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kumamoto-shi
Zip:
860-8556
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kurume-shi
Zip:
830-0011
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Matsuyama-shi
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
467-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Niigata-shi
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nishinomiya-shi
Zip:
663-8501
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ota-shi
Zip:
373-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sendai-shi
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinagawa-ku
Zip:
142-8666
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinjuku-ku
Zip:
160-0023
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinjuku-ku
Zip:
162-8655
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tsu-shi
Zip:
514-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tsukuba
Zip:
305-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06273
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
CD Mexico
Zip:
04980
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guadalajara
Zip:
44638
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guadalajara
Zip:
44670
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Mexico City
Zip:
0 3100
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Mexico
Zip:
6760
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
México
Zip:
04700
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tuxtla Gutierrez
Zip:
29090
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bacolod
Zip:
6100
Country:
Philippines
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cebu City
Zip:
6000
Country:
Philippines
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Manila
Zip:
1000
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Muntinlupa City
Zip:
1780
Country:
Philippines
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quezon City
Zip:
1112
Country:
Philippines
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Juan
Zip:
1502
Country:
Philippines
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Białystok
Zip:
15-027
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Konin
Zip:
62-500
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-115
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Legnica
Zip:
59-220
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wroclaw
Zip:
53-413
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Łódź
Zip:
90-302
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
329563
Country:
Singapore
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Cape Town
Zip:
7570
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Johannesburg
Zip:
2013
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Johannesburg
Zip:
2193
Country:
South Africa
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paarl
Zip:
7646
Country:
South Africa
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pretoria
Zip:
0081
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Granada
Zip:
18016
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hospitalet deLlobregat
Zip:
08907
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hsinchu
Zip:
300
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
11259
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10210
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dusit
Zip:
10300
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khon Kaen
Zip:
40002
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Songkhla
Zip:
90110
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06520
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
6200
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Besevler Ankara
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Küçükçekmece
Zip:
34295
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Samsun
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cardiff
Zip:
CF14 2TL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelsea
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leicester
Zip:
Le5 4PW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Liverpool
Zip:
L7 8YA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SW17 0QT
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Surrey
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taunton
Zip:
TA1 5DA
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hanoi
Zip:
100000
Country:
Vietnam
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ho Chi Minh City
Zip:
700000
Country:
Vietnam
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vinh
Zip:
460000
Country:
Vietnam
Status:
Not yet recruiting
Start date:
November 23, 2023
Completion date:
April 23, 2029
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103864
https://www.breastcancerstudylocator.com/trial/listing/431555
