Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; HER2-positive Early Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab Deruxtecan; Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Doxorubicin; Drug: cyclophosphamide

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).

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Withdrawn
    • Research Site
  • Salzburg, Austria, 5020
    • Withdrawn
    • Research Site
  • Wien, Austria, 1130
    • Withdrawn
    • Research Site
  • Wien, Austria, 1190
    • Withdrawn
    • Research Site
• Brazil
  • Goiânia, Brazil, 74000-000
    • Active, not recruiting
    • Research Site
  • Ijuí, Brazil, 98700-000
    • Active, not recruiting
    • Research Site
  • Natal, Brazil, 59075-740
    • Active, not recruiting
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Active, not recruiting
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Active, not recruiting
    • Research Site
  • São Paulo, Brazil, 01221-020
    • Active, not recruiting
    • Research Site
  • São Paulo, Brazil, 01229-010
    • Active, not recruiting
    • Research Site
  • Vitoria, Brazil, 29043-260
    • Withdrawn
    • Research Site
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Completed
    • Research Site
  • Pleven, Bulgaria, 5804
    • Withdrawn
    • Research Site
  • Plovdiv, Bulgaria, 4000
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1407
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1303
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1330
    • Completed
    • Research Site
• Canada
  • Montreal, Canada, H3T 1E2
    • Active, not recruiting
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Active, not recruiting
      • Research Site
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • Withdrawn
      • Research Site
  • Ontario
    • Sault Ste. Marie, Ontario, Canada, P6A 0A8
      • Withdrawn
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X5
      • Active, not recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A-3J1
      • Active, not recruiting
      • Research Site
    • Quebec City, Quebec, Canada, G1S 4L8
      • Active, not recruiting
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Active, not recruiting
      • Research Site
• China
  • Beijing, China, 100039
    • Active, not recruiting
    • Research Site
  • Changsha, China, 410013
    • Active, not recruiting
    • Research Site
  • Changsha, China, 410008
    • Active, not recruiting
    • Research Site
  • Chengdu, China, 610041
    • Recruiting
    • Research Site
  • Chongqing, China, 400030
    • Active, not recruiting
    • Research Site
  • Guangzhou, China, 510060
    • Active, not recruiting
    • Research Site
  • Guangzhou, China, 510080
    • Active, not recruiting
    • Research Site
  • Guangzhou, China, 510700
    • Active, not recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Withdrawn
    • Research Site
  • Kunming, China, 650118
    • Active, not recruiting
    • Research Site
  • Nanjing, China, 210029
    • Terminated
    • Research Site
  • Nanning, China, 530021
    • Active, not recruiting
    • Research Site
  • Qingdao, China, 266100
    • Active, not recruiting
    • Research Site
  • Shanghai, China, 200032
    • Active, not recruiting
    • Research Site
  • Shanghai, China, 200433
    • Terminated
    • Research Site
  • Shenyang, China, 110001
    • Active, not recruiting
    • Research Site
  • Tianjin, China, 300060
    • Active, not recruiting
    • Research Site
  • Wuhan, China, 430079
    • Active, not recruiting
    • Research Site
  • Wuhan, China, 430060
    • Active, not recruiting
    • Research Site
  • Xi'an, China, 710032
    • Withdrawn
    • Research Site
  • Zhengzhou, China, 450008
    • Active, not recruiting
    • Research Site
• Germany
  • Aschaffenburg, Germany, 63739
    • Withdrawn
    • Research Site
  • Augsburg, Germany, 86156
    • Active, not recruiting
    • Research Site
  • Berlin, Germany, 10117
    • Active, not recruiting
    • Research Site
  • Erlangen, Germany, 91054
    • Active, not recruiting
    • Research Site
  • Hamburg, Germany, 20357
    • Active, not recruiting
    • Research Site
  • Heidelberg, Germany, 69120
    • Active, not recruiting
    • Research Site
  • Kiel, Germany, 24105
    • Active, not recruiting
    • Research Site
  • Leipzig, Germany, 4103
    • Active, not recruiting
    • Research Site
  • Muenster, Germany, 48149
    • Active, not recruiting
    • Research Site
  • Mönchengladbach, Germany, 41061
    • Active, not recruiting
    • Research Site
  • München, Germany, 81377
    • Active, not recruiting
    • Research Site
  • Offenbach am Main, Germany, 63069
    • Withdrawn
    • Research Site
  • Paderborn, Germany, 33098
    • Active, not recruiting
    • Research Site
  • Tübingen, Germany, 72076
    • Active, not recruiting
    • Research Site
• India
  • Gurgaon, India, 122001
    • Active, not recruiting
    • Research Site
  • Howrah, India, 711103
    • Active, not recruiting
    • Research Site
  • Ludhiana, India, 141002
    • Withdrawn
    • Research Site
  • Manipal, India, 576104
    • Withdrawn
    • Research Site
  • Mumbai, India, 400012
    • Withdrawn
    • Research Site
  • Mumbai, India, 400092
    • Withdrawn
    • Research Site
  • Nagpur, India, 440001
    • Active, not recruiting
    • Research Site
  • Nashik, India, 422002
    • Active, not recruiting
    • Research Site
  • New Delhi, India, 110029
    • Active, not recruiting
    • Research Site
  • New Delhi, India, 110 085
    • Active, not recruiting
    • Research Site
  • Raipur, India, 492001
    • Terminated
    • Research Site
  • Rishikesh, India, 249203
    • Active, not recruiting
    • Research Site
  • Surat, India, 395002
    • Active, not recruiting
    • Research Site
  • Thiruvananthapuram, India, 695011
    • Active, not recruiting
    • Research Site
  • Vadodara, India, 390012
    • Withdrawn
    • Research Site
• Italy
  • Bologna, Italy, 40138
    • Active, not recruiting
    • Research Site
  • Candiolo, Italy, 10060
    • Active, not recruiting
    • Research Site
  • Livorno, Italy, 57100
    • Active, not recruiting
    • Research Site
  • Milano, Italy, 20132
    • Active, not recruiting
    • Research Site
  • Naples, Italy, 80131
    • Active, not recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Active, not recruiting
    • Research Site
  • Negrar, Italy, 37024
    • Active, not recruiting
    • Research Site
  • Padova, Italy, 35128
    • Active, not recruiting
    • Research Site
  • Rome, Italy, 168
    • Active, not recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Active, not recruiting
    • Research Site
• Japan
  • Chuo-ku, Japan, 104-8560
    • Active, not recruiting
    • Research Site
  • Chuo-ku, Japan, 862-8655
    • Active, not recruiting
    • Research Site
  • Hidaka-shi, Japan, 350-1298
    • Active, not recruiting
    • Research Site
  • Hiroshima-shi, Japan, 734-8551
    • Active, not recruiting
    • Research Site
  • Kawasaki-shi, Japan, 216-8511
    • Active, not recruiting
    • Research Site
  • Koto-ku, Japan, 135-8550
    • Active, not recruiting
    • Research Site
  • Nagoya-shi, Japan, 467-0001
    • Active, not recruiting
    • Research Site
  • Nagoya-shi, Japan, 466-8560
    • Active, not recruiting
    • Research Site
  • Ota-shi, Japan, 373-8550
    • Active, not recruiting
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Active, not recruiting
    • Research Site
• Korea, Republic of
  • Goyang-si, Korea, Republic of, 10408
    • Active, not recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Active, not recruiting
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Active, not recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Active, not recruiting
    • Research Site
  • Seoul, Korea, Republic of, 06273
    • Active, not recruiting
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Active, not recruiting
    • Research Site
• Peru
  • Arequipa, Peru, AREQUIPA01
    • Withdrawn
    • Research Site
  • Lima, Peru, Lima 32
    • Active, not recruiting
    • Research Site
  • Lima, Peru, L41
    • Withdrawn
    • Research Site
  • Lima, Peru, 15033
    • Active, not recruiting
    • Research Site
  • Lima, Peru, LIMA 34
    • Active, not recruiting
    • Research Site
  • Lima, Peru, LIMA 27
    • Withdrawn
    • Research Site
  • Lima, Peru, LIMA 29
    • Active, not recruiting
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Active, not recruiting
    • Research Site
  • Cebu City, Philippines, 6000
    • Active, not recruiting
    • Research Site
  • Davao City, Philippines, 8000
    • Active, not recruiting
    • Research Site
  • Iloilo, Philippines, 5000
    • Terminated
    • Research Site
  • Manila, Philippines, 1000
    • Withdrawn
    • Research Site
  • Quezon City, Philippines, 1112
    • Active, not recruiting
    • Research Site
  • San Juan, Philippines
    • Active, not recruiting
    • Research Site
• Poland
  • Biała Podlaska, Poland, 21-500
    • Active, not recruiting
    • Research Site
  • Białystok, Poland, 15-027
    • Active, not recruiting
    • Research Site
  • Bydgoszcz, Poland, 85-796
    • Active, not recruiting
    • Research Site
  • Koszalin, Poland, 75-581
    • Active, not recruiting
    • Research Site
  • Lublin, Poland, 20-090
    • Active, not recruiting
    • Research Site
  • Rzeszów, Poland, 35-021
    • Withdrawn
    • Research Site
  • Rzeszów, Poland, 30-055
    • Terminated
    • Research Site
  • Warszawa, Poland, 02-781
    • Active, not recruiting
    • Research Site
  • Wroclaw, Poland, 53-413
    • Withdrawn
    • Research Site
  • Łódź, Poland, 90-242
    • Withdrawn
    • Research Site
  • Łódź, Poland, 92-213
    • Withdrawn
    • Research Site
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Withdrawn
    • Research Site
  • Moscow, Russian Federation, 121205
    • Withdrawn
    • Research Site
  • Moscow, Russian Federation, 117997
    • Active, not recruiting
    • Research Site
  • Moscow, Russian Federation, 111123
    • Withdrawn
    • Research Site
  • Moscow, Russian Federation, 143423
    • Active, not recruiting
    • Research Site
  • Saint Petersburg, Russian Federation, 197758
    • Active, not recruiting
    • Research Site
  • Saint Petersburg, Russian Federation, 194017
    • Withdrawn
    • Research Site
  • Saint Petersburg, Russian Federation, 198217
    • Withdrawn
    • Research Site
  • Saint Petersburg, Russian Federation, 190020
    • Active, not recruiting
    • Research Site
  • Saint-Petersburg, Russian Federation, 197758
    • Withdrawn
    • Research Site
• Saudi Arabia
  • Ar Riyāḑ, Saudi Arabia, 11426
    • Recruiting
    • Research Site
  • Dammam, Saudi Arabia, 31444
    • Recruiting
    • Research Site
  • Jeddah, Saudi Arabia, 23214
    • Recruiting
    • Research Site
  • Jeddah, Saudi Arabia, 21423
    • Recruiting
    • Research Site
  • Riyadh, Saudi Arabia, 12987
    • Withdrawn
    • Research Site
  • Riyadh, Saudi Arabia, 11525
    • Withdrawn
    • Research Site
  • Riyadh, Saudi Arabia, 3354
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Research Site
  • Barcelona, Spain, 08028
    • Active, not recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Active, not recruiting
    • Research Site
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Research Site
  • Sevilla, Spain, 41013
    • Active, not recruiting
    • Research Site
  • Vigo, Spain, 36312
    • Active, not recruiting
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 82445
    • Active, not recruiting
    • Research Site
  • Taichung, Taiwan, 40443
    • Active, not recruiting
    • Research Site
  • Tainan, Taiwan, 710
    • Active, not recruiting
    • Research Site
  • Tainan, Taiwan, 70403
    • Withdrawn
    • Research Site
  • Taipei, Taiwan, 100
    • Active, not recruiting
    • Research Site
  • Taipei 112, Taiwan
    • Active, not recruiting
    • Research Site
  • Taipei City, Taiwan, 114
    • Active, not recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Active, not recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10210
    • Active, not recruiting
    • Research Site
  • Bangkok, Thailand, 10330
    • Active, not recruiting
    • Research Site
  • Bangkok, Thailand, 10330
    • Withdrawn
    • Research Site
  • Bangkok, Thailand, 10400
    • Active, not recruiting
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Active, not recruiting
    • Research Site
  • Hat Yai, Thailand, 90110
    • Active, not recruiting
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Terminated
    • Research Site
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Active, not recruiting
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Active, not recruiting
      • Research Site
    • Glendale, California, United States, 91204
      • Active, not recruiting
      • Research Site
    • Los Alamitos, California, United States, 90720
      • Active, not recruiting
      • Research Site
    • Orange, California, United States, 92868
      • Active, not recruiting
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Withdrawn
      • Research Site
    • Grand Junction, Colorado, United States, 81501
      • Recruiting
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Active, not recruiting
      • Research Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Withdrawn
      • Research Site
    • Miami, Florida, United States, 33136
      • Withdrawn
      • Research Site
    • Saint Petersburg, Florida, United States, 33705
      • Withdrawn
      • Research Site
    • Tallahassee, Florida, United States, 32308
      • Withdrawn
      • Research Site
    • West Palm Beach, Florida, United States, 33401
      • Withdrawn
      • Research Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Withdrawn
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Active, not recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Completed
      • Research Site
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Terminated
      • Research Site
  • Maine
    • Scarborough, Maine, United States, 04074
      • Recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Research Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Withdrawn
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Active, not recruiting
      • Research Site
  • Montana
    • Billings, Montana, United States, 59102
      • Withdrawn
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Withdrawn
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Active, not recruiting
      • Research Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Active, not recruiting
      • Research Site
    • Hackensack, New Jersey, United States, 07601
      • Withdrawn
      • Research Site
    • Little Silver, New Jersey, United States, 07739
      • Withdrawn
      • Research Site
    • Summit, New Jersey, United States, 07901
      • Active, not recruiting
      • Research Site
  • New York
    • Commack, New York, United States, 11725
      • Active, not recruiting
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Active, not recruiting
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Withdrawn
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Active, not recruiting
      • Research Site
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Terminated
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • Research Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Active, not recruiting
      • Research Site
  • Utah
    • Ogden, Utah, United States, 84405
      • Active, not recruiting
      • Research Site
    • Salt Lake City, Utah, United States, 84106
      • Withdrawn
      • Research Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Withdrawn
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Active, not recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Trastuzumab deruxtecan	Drug: Trastuzumab Deruxtecan; administered by intravenous infusion; Other Names: Enhertu; T-DXd
Experimental: Arm B; T-DXd, followed by THP	Drug: Trastuzumab Deruxtecan; administered by intravenous infusion; Other Names: Enhertu; T-DXd; Drug: Paclitaxel; administered by intravenous infusion; Other Names: Taxol; Onxol; Drug: Trastuzumab; administered by intravenous infusion; Other Names: Herceptin; Herzuma; Drug: Pertuzumab; administered by intravenous infusion; Other Names: Perjeta
Active Comparator: Arm C; doxorubicin and cyclophosphamide, followed by THP	Drug: Paclitaxel; administered by intravenous infusion; Other Names: Taxol; Onxol; Drug: Trastuzumab; administered by intravenous infusion; Other Names: Herceptin; Herzuma; Drug: Pertuzumab; administered by intravenous infusion; Other Names: Perjeta; Drug: Doxorubicin; administered by intravenous infusion; Other Names: Adriamycin; Rubex; Drug: cyclophosphamide; administered by intravenous infusion; Other Names: Cytoxan; Neosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Event-Free Survival	Up to 72 months after study start
Invasive Disease-Free Survival (IDFS)	Up to 72 months after study start
Overall Survival	Up to 72 months after study start

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; breast neoplasms; Antineoplastic Agents, Phytogenic; Trastuzumab Trastuzumab Deruxtecan (T-DXd; DS-8201a); DESTINY-BREAST11; Receptor, ErbB-2; Antineoplastic Agents;Molecular Mechanisms of Pharmacological Action; DB11; Enhertu; HER2 (human epidermal growth factor receptor 2)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Immunoconjugates; Cyclophosphamide; Paclitaxel; Trastuzumab; Doxorubicin; Pertuzumab; Trastuzumab deruxtecan
• Other Study ID Numbers: D967RC00001; 2021-000603-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No