Breast NeoplasmsPhase 3NCT05113251
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
A Phase 3 study testing Trastuzumab Deruxtecan, Paclitaxel and Trastuzumab in people with Breast Neoplasms and Breast Cancer, run by AstraZeneca at 145 sites in 18 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- What is being tested?
- Trastuzumab Deruxtecan, Paclitaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 927 participants
- Where
- 145 sitesin 18 countries
- Study dates
- 25 Oct 2021to 30 Apr 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
145 sites in 18 countries.
145 sites in 18 countries
United States22 sites
Research Site
Beverly Hills, California, 90211
Research Site
Commack, New York, 11725
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Durham, North Carolina, 27710
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East Brunswick, New Jersey, 08816
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Fort Wayne, Indiana, 46804
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Fort Worth, Texas, 76104
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Germantown, Tennessee, 38138
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Glendale, California, 91204
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Greenville, South Carolina, 29607
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Las Vegas, Nevada, 89102
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Lexington, Kentucky, 40503
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Los Alamitos, California, 90720
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Louisville, Kentucky, 40202
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Minneapolis, Minnesota, 55407
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Nashville, Tennessee, 37203
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New Haven, Connecticut, 06510
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Ogden, Utah, 84405
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Orange, California, 92868
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Shreveport, Louisiana, 71101
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Springdale, Arkansas, 72762
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Summit, New Jersey, 07901
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Tacoma, Washington, 98405
China16 sites
Research Site
Beijing, 100039
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Changsha, 410008
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Changsha, 410013
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Chongqing, 400030
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Guangzhou, 510060
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Guangzhou, 510080
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Guangzhou, 510700
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Kunming, 650118
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Nanning, 530021
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Qingdao, 266100
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Shanghai, 200032
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Shenyang, 110001
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Tianjin, 300060
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Wuhan, 430060
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Wuhan, 430079
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Zhengzhou, 450008
Germany12 sites
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Augsburg, 86156
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Berlin, 10117
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Erlangen, 91054
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Hamburg, 20357
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Heidelberg, 69120
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Kiel, 24105
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Leipzig, 4103
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Mönchengladbach, 41061
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München, 81377
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Münster, 48149
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Paderborn, 33098
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Tübingen, 72076
India10 sites
Research Site
Gūrgaon, 122001
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Howrah, 711103
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Nagpur, 440001
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Nashik, 422002
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New Delhi, 110 085
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New Delhi, 110029
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Raipur, 492001
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Rishikesh, 249203
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Surat, 395002
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Thiruvananthapuram, 695011
Japan10 sites
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Chūōku, 104-8560
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Chūōku, 862-8655
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Hidaka-shi, 350-1298
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Hiroshima, 734-8551
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Kawasaki-shi, 216-8511
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Kōtoku, 135-8550
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Nagoya, 466-8560
Research Site
Nagoya, 467-8602
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Ota-shi, 373-8550
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Shinjuku-ku, 162-8655
Italy9 sites
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Bologna, 40138
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Candiolo, 10060
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Livorno, 57100
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Milan, 20132
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Naples, 80131
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Negrar, 37024
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Padova, 35128
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Roma, 00168
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Rozzano, 20089
Brazil7 sites
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Goiânia, 74000-000
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Ijuí, 98700-000
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Natal, 59075-740
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Porto Alegre, 90610-000
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Porto Alegre, 91350-200
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São Paulo, 01221-020
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São Paulo, 01229-010
Poland7 sites
Research Site
Biała Podlaska, 21-500
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Bialystok, 15-027
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Bydgoszcz, 85-796
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Koszalin, 75-581
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Lublin, 20-090
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Rzeszów, 30-055
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Warsaw, 02-781
Taiwan7 sites
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Kaohsiung City, 82445
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Taichung, 40443
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Tainan, 710
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Taipei, 100
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Taipei, 11217
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Taipei, 114
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Taoyuan, 333
Canada6 sites
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Edmonton, Alberta, T6G 1Z2
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Montreal, Quebec, H4A-3J1
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Montreal, H3T 1E2
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Québec, Quebec, G1S 4L8
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Sherbrooke, Quebec, J1H 5N4
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Toronto, Ontario, M5G 1X5
Philippines6 sites
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Bacolod, 6100
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Cebu City, 6000
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Davao City, 8000
Research Site
Iloilo City, 5000
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Quezon City, 1112
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San Juan City
South Korea6 sites
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Goyang-si, 10408
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06273
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Seoul, 06351
Spain6 sites
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Barcelona, 08028
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Barcelona, 08035
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Madrid, 28007
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Madrid, 28040
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Seville, 41013
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Vigo, 36312
Thailand6 sites
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Bangkok, 10210
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Bangkok, 10330
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Bangkok, 10400
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Chiang Mai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
Saudi Arabia5 sites
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Dammam, 31444
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Jeddah, 21423
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Jeddah, 23214
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Riyadh, 11426
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Riyadh, 3354
Peru4 sites
Research Site
Lima, 15033
Research Site
Lima, LIMA 29
Research Site
Lima, Lima 32
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Lima, LIMA 34
Russia4 sites
Research Site
Moscow, 117997
Research Site
Moscow, 143423
Research Site
Saint Petersburg, 190020
Research Site
Saint Petersburg, 197758
About this study
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)
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.
Read the 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).
- Being tested
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab DeruxtecanDrug
Also called T-DXd, Enhertu
administered by intravenous infusion
PaclitaxelDrug
Also called Taxol, Onxol
administered by intravenous infusion
TrastuzumabDrug
Also called Herceptin, Herzuma
administered by intravenous infusion
PertuzumabDrug
Also called Perjeta
administered by intravenous infusion
DoxorubicinDrug
Also called Adriamycin, Rubex
administered by intravenous infusion
cyclophosphamideDrug
Also called Neosar, Cytoxan
administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Trastuzumab deruxtecan Receives: Drug: Trastuzumab Deruxtecan |
| Arm B | Experimental | T-DXd, followed by THP Receives: Drug: Trastuzumab Deruxtecan; Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab |
| Arm C | Active comparator | doxorubicin and cyclophosphamide, followed by THP Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Doxorubicin; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathologic Complete Response (pCR).
Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
Measured: Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
Secondary outcomes (2)
Event-Free Survival (Count)
Event-free survival (EFS) is defined as the time from date of randomization until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Measured: Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
Event-Free Survival (Duration)
Event-free survival (EFS) is defined as the time from date of randomization until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Measured: Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start25 Oct 2021
- Primary completion12 Mar 2025
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three arms in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113251
- Sponsor's protocol ID
- D967RC00001
- Other IDs
- 2023-505210-18-00, 2021-000603-21, 2023
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2021
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient 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