Back to resultsTrastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Primary Purpose
Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trastuzumab Deruxtecan
Paclitaxel
Trastuzumab
Pertuzumab
Doxorubicin
cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Trastuzumab Trastuzumab Deruxtecan (T-DXd; DS-8201a), DESTINY-BREAST11, Receptor, ErbB-2, breast neoplasms, Antineoplastic Agents, Phytogenic, Antineoplastic Agents;Molecular Mechanisms of Pharmacological Action, DB11, Enhertu, HER2 (human epidermal growth factor receptor 2), breast cancer
Eligibility Criteria
Key Inclusion Criteria:
- Patients must be at least 18 years of age.
- Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
- ECOG performance status of 0 or 1 at randomization
- Adequate organ and bone marrow function
- LVEF ≥ 50% within 28 days before randomization
- FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician
Exclusion Criteria:
- prior history of invasive breast cancer
- stage IV breast cancer (determined by AJCC staging system)
- any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer)
- history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
- History of, or current, ILD/pneumonitis
- Prior systemic therapy for the treatment of breast cancer
- Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm C
Arm Description
Trastuzumab deruxtecan
T-DXd, followed by THP
doxorubicin and cyclophosphamide, followed by THP
Outcomes
Primary Outcome Measures
rate of pathologic complete response (pCR)
Proportion of participants who have no evidence by H&E staining of residual invasive disease
Secondary Outcome Measures
Event-Free Survival
Invasive Disease-Free Survival (IDFS)
Overall Survival
Full Information
NCT ID
NCT05113251
First Posted
October 22, 2021
Last Updated
September 26, 2023
Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05113251
Brief Title
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Official Title
A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Detailed Description
The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy.
Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
Keywords
Trastuzumab Trastuzumab Deruxtecan (T-DXd; DS-8201a), DESTINY-BREAST11, Receptor, ErbB-2, breast neoplasms, Antineoplastic Agents, Phytogenic, Antineoplastic Agents;Molecular Mechanisms of Pharmacological Action, DB11, Enhertu, HER2 (human epidermal growth factor receptor 2), breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of three arms in parallel for the duration of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Trastuzumab deruxtecan
Arm Title
Arm B
Arm Type
Experimental
Arm Description
T-DXd, followed by THP
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
doxorubicin and cyclophosphamide, followed by THP
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Deruxtecan
Other Intervention Name(s)
T-DXd, Enhertu
Intervention Description
administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Onxol
Intervention Description
administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin, Herzuma
Intervention Description
administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin, Rubex
Intervention Description
administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Neosar, Cytoxan
Intervention Description
administered by intravenous infusion
Primary Outcome Measure Information:
Title
rate of pathologic complete response (pCR)
Description
Proportion of participants who have no evidence by H&E staining of residual invasive disease
Time Frame
Up to 39 months after study start
Secondary Outcome Measure Information:
Title
Event-Free Survival
Time Frame
Up to 72 months after study start
Title
Invasive Disease-Free Survival (IDFS)
Time Frame
Up to 72 months after study start
Title
Overall Survival
Time Frame
Up to 72 months after study start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Patients must be at least 18 years of age.
Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
ECOG performance status of 0 or 1 at randomization
Adequate organ and bone marrow function
LVEF ≥ 50% within 28 days before randomization
FFPE tissue block (2 cores) or 20 freshly-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician
Exclusion Criteria:
prior history of invasive breast cancer
stage IV breast cancer (determined by AJCC staging system)
any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease) Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer)
history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
History of, or current, ILD/pneumonitis
Prior systemic therapy for the treatment of breast cancer
Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Little Silver
State/Province
New Jersey
ZIP/Postal Code
07739
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1190
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Goiânia
ZIP/Postal Code
74000-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ijuí
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01229-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vitoria
ZIP/Postal Code
29043-260
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6A 0A8
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A-3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Qingdao
ZIP/Postal Code
266100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710032
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Offenbach am Main
ZIP/Postal Code
63069
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Howrah
ZIP/Postal Code
711103
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141002
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Manipal
ZIP/Postal Code
576104
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400092
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110 085
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Raipur
ZIP/Postal Code
492001
Country
India
Individual Site Status
Terminated
Facility Name
Research Site
City
Rishikesh
ZIP/Postal Code
249203
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Surat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Thiruvananthapuram
ZIP/Postal Code
695011
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vadodara
ZIP/Postal Code
390012
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rome
ZIP/Postal Code
168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
862-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
467-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ota-shi
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Arequipa
ZIP/Postal Code
AREQUIPA01
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L41
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bacolod
ZIP/Postal Code
6100
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Terminated
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Juan
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
30-055
Country
Poland
Individual Site Status
Terminated
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198217
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ar Riyāḑ
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dammam
ZIP/Postal Code
31444
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
23214
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
11525
Country
Saudi Arabia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
12987
Country
Saudi Arabia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
3354
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40443
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei 112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient data from AstraZeneca Group of Companies, sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ Disclosure Commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved, AstraZeneca will provide access to the de-identified patient level data in an approved sponsor tool. Signed Data Sharing Agreements (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Learn more about this trial
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
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