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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05113251
Other study ID # D967RC00001
Secondary ID 2021-000603-21
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 25, 2021
Est. completion date April 30, 2027

Study information

Verified date March 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date April 30, 2027
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Trastuzumab Deruxtecan
administered by intravenous infusion
Paclitaxel
administered by intravenous infusion
Trastuzumab
administered by intravenous infusion
Pertuzumab
administered by intravenous infusion
Doxorubicin
administered by intravenous infusion
cyclophosphamide
administered by intravenous infusion

Locations

Country Name City State
Austria Research Site Innsbruck
Austria Research Site Salzburg
Austria Research Site Wien
Austria Research Site Wien
Brazil Research Site Goiânia
Brazil Research Site Ijuí
Brazil Research Site Natal
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site São Paulo
Brazil Research Site São Paulo
Brazil Research Site Vitoria
Bulgaria Research Site Panagyurishte
Bulgaria Research Site Pleven
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Canada Research Site Edmonton Alberta
Canada Research Site Montreal
Canada Research Site Montreal Quebec
Canada Research Site Quebec City Quebec
Canada Research Site Sault Ste. Marie Ontario
Canada Research Site Sherbrooke Quebec
Canada Research Site Toronto Ontario
Canada Research Site Victoria British Columbia
China Research Site Beijing
China Research Site Changsha
China Research Site Changsha
China Research Site Chengdu
China Research Site Chongqing
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Guangzhou
China Research Site Hangzhou
China Research Site Kunming
China Research Site Nanjing
China Research Site Nanning
China Research Site Qingdao
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenyang
China Research Site Tianjin
China Research Site Wuhan
China Research Site Wuhan
China Research Site Xi'an
China Research Site Zhengzhou
Germany Research Site Aschaffenburg
Germany Research Site Augsburg
Germany Research Site Berlin
Germany Research Site Erlangen
Germany Research Site Hamburg
Germany Research Site Heidelberg
Germany Research Site Kiel
Germany Research Site Leipzig
Germany Research Site Mönchengladbach
Germany Research Site Muenster
Germany Research Site München
Germany Research Site Offenbach am Main
Germany Research Site Paderborn
Germany Research Site Tübingen
India Research Site Gurgaon
India Research Site Howrah
India Research Site Ludhiana
India Research Site Manipal
India Research Site Mumbai
India Research Site Mumbai
India Research Site Nagpur
India Research Site Nashik
India Research Site New Delhi
India Research Site New Delhi
India Research Site Raipur
India Research Site Rishikesh
India Research Site Surat
India Research Site Thiruvananthapuram
India Research Site Vadodara
Italy Research Site Bologna
Italy Research Site Candiolo
Italy Research Site Livorno
Italy Research Site Milano
Italy Research Site Naples
Italy Research Site Napoli
Italy Research Site Negrar
Italy Research Site Padova
Italy Research Site Rome
Italy Research Site Rozzano
Japan Research Site Chuo-ku
Japan Research Site Chuo-ku
Japan Research Site Hidaka-shi
Japan Research Site Hiroshima-shi
Japan Research Site Kawasaki-shi
Japan Research Site Koto-ku
Japan Research Site Nagoya-shi
Japan Research Site Nagoya-shi
Japan Research Site Ota-shi
Japan Research Site Shinjuku-ku
Korea, Republic of Research Site Goyang-si
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Peru Research Site Arequipa
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Philippines Research Site Bacolod
Philippines Research Site Cebu City
Philippines Research Site Davao City
Philippines Research Site Iloilo
Philippines Research Site Manila
Philippines Research Site Quezon City
Philippines Research Site San Juan
Poland Research Site Biala Podlaska
Poland Research Site Bialystok
Poland Research Site Bydgoszcz
Poland Research Site Koszalin
Poland Research Site Lódz
Poland Research Site Lódz
Poland Research Site Lublin
Poland Research Site Rzeszów
Poland Research Site Rzeszów
Poland Research Site Warszawa
Poland Research Site Wroclaw
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint-Petersburg
Saudi Arabia Research Site Ar Riya?
Saudi Arabia Research Site Dammam
Saudi Arabia Research Site Jeddah
Saudi Arabia Research Site Jeddah
Saudi Arabia Research Site Riyadh
Saudi Arabia Research Site Riyadh
Saudi Arabia Research Site Riyadh
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Sevilla
Spain Research Site Vigo
Taiwan Research Site Kaohsiung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Taipei 112
Taiwan Research Site Taipei City
Taiwan Research Site Taoyuan
Thailand Research Site Bangkok
Thailand Research Site Bangkok
Thailand Research Site Bangkok
Thailand Research Site Chiang Mai
Thailand Research Site Hat Yai
Thailand Research Site Khon Kaen
United States Research Site Baltimore Maryland
United States Research Site Beverly Hills California
United States Research Site Billings Montana
United States Research Site Burlington Vermont
United States Research Site Coeur d'Alene Idaho
United States Research Site Commack New York
United States Research Site Denver Colorado
United States Research Site Durham North Carolina
United States Research Site East Brunswick New Jersey
United States Research Site Fort Myers Florida
United States Research Site Fort Wayne Indiana
United States Research Site Fort Worth Texas
United States Research Site Germantown Tennessee
United States Research Site Glendale California
United States Research Site Grand Junction Colorado
United States Research Site Grand Rapids Michigan
United States Research Site Greenville South Carolina
United States Research Site Hackensack New Jersey
United States Research Site Las Vegas Nevada
United States Research Site Lexington Kentucky
United States Research Site Little Silver New Jersey
United States Research Site Los Alamitos California
United States Research Site Louisville Kentucky
United States Research Site Miami Florida
United States Research Site Minneapolis Minnesota
United States Research Site Nashville Tennessee
United States Research Site New Haven Connecticut
United States Research Site Ogden Utah
United States Research Site Omaha Nebraska
United States Research Site Orange California
United States Research Site Pittsburgh Pennsylvania
United States Research Site Saint Petersburg Florida
United States Research Site Salt Lake City Utah
United States Research Site Scarborough Maine
United States Research Site Shreveport Louisiana
United States Research Site Springdale Arkansas
United States Research Site Summit New Jersey
United States Research Site Tacoma Washington
United States Research Site Tallahassee Florida
United States Research Site West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Daiichi Sankyo

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Bulgaria,  Canada,  China,  Germany,  India,  Italy,  Japan,  Korea, Republic of,  Peru,  Philippines,  Poland,  Russian Federation,  Saudi Arabia,  Spain,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of pathologic complete response (pCR) Proportion of participants who have no evidence by H&E staining of residual invasive disease Up to 39 months after study start
Secondary Event-Free Survival Up to 72 months after study start
Secondary Invasive Disease-Free Survival (IDFS) Up to 72 months after study start
Secondary Overall Survival Up to 72 months after study start
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