Skip to content
Triangle logo TriangleGet started
← Study library

NCT05113251 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Rate of Pathologic Complete Response (pCR).

→

outcome · NOT POSTED

Event-Free Survival (Count)

→

outcome · NOT POSTED

Event-Free Survival (Duration)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Trastuzumab deruxtecan
    intervention Names
    1. Drug: Trastuzumab Deruxtecan
    label
    Arm A
    type
    EXPERIMENTAL
  2. description
    T-DXd, followed by THP
    intervention Names
    1. Drug: Trastuzumab Deruxtecan
    2. Drug: Paclitaxel
    3. Drug: Trastuzumab
    4. Drug: Pertuzumab
    label
    Arm B
    type
    EXPERIMENTAL
  3. description
    doxorubicin and cyclophosphamide, followed by THP
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Trastuzumab
    3. Drug: Pertuzumab
    4. Drug: Doxorubicin
    5. Drug: cyclophosphamide
    label
    Arm C
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm A
    2. Arm B
    description
    administered by intravenous infusion
    name
    Trastuzumab Deruxtecan
    other Names
    1. T-DXd
    2. Enhertu
    type
    DRUG
  2. arm Group Labels
    1. Arm B
    2. Arm C
    description
    administered by intravenous infusion
    name
    Paclitaxel
    other Names
    1. Taxol
    2. Onxol
    type
    DRUG
  3. arm Group Labels
    1. Arm B
    2. Arm C
    description
    administered by intravenous infusion
    name
    Trastuzumab
    other Names
    1. Herceptin
    2. Herzuma
    type
    DRUG
  4. arm Group Labels
    1. Arm B
    2. Arm C
    description
    administered by intravenous infusion
    name
    Pertuzumab
    other Names
    1. Perjeta
    type
    DRUG
  5. arm Group Labels
    1. Arm C
    description
    administered by intravenous infusion
    name
    Doxorubicin
    other Names
    1. Adriamycin
    2. Rubex
    type
    DRUG
  6. arm Group Labels
    1. Arm C
    description
    administered by intravenous infusion
    name
    cyclophosphamide
    other Names
    1. Neosar
    2. Cytoxan
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
intervention Model Description
Participants are assigned to one of three arms in parallel for the duration of the study.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
927
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Rate of Pathologic Complete Response (pCR).
    time Frame
    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
  1. description
    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.
    measure
    Event-Free Survival (Count)
    time Frame
    Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
  2. description
    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.
    measure
    Event-Free Survival (Duration)
    time Frame
    Up to a maximum of approximately 65 months from randomization to EFS final analysis DCO (Apr 2027)
Full 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).
Source references
see Also Links
  1. label
    Redacted SAP
  2. label
    Redacted CSP
  3. label
    Redacted CSR synopsis
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-53f57e13a3930913560a
      requested nct id
      NCT05113251
      primary nct id
      NCT05113251
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      source record id
      a4106ba4-f398-4663-980c-2b7195283edd
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      payload sha256
      3551d9ba4c2d377464166c2512287a0b88d7b7a17a64887f0fa09ed1f9335b33
      payload
      application numbers
      1. BLA761139
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-53f57e13a3930913560a
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT05113251
      occurrences
      1. context exact
        14 CLINICAL STUDIES 14.1 HER2-Positive Early Breast Cancer DESTINY-Breast11 The efficacy of ENHERTU followed by THP was evaluated in DESTINY-Breast11 (NCT05113251), a randomized, three-arm, open-label, multicenter, global study that enrolled 927 adult patients with HER2-positive, high-risk, early-stage breast cancer. The
        end
        162
        exact text
        NCT05113251
        start
        151
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00500.json
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      source json pointer
      /results/82/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      a4106ba4-f398-4663-980c-2b7195283edd
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2a5c82cae51b76ab795b3709725fbbf87538a8fd70e4f14e653fb5a6a43bfd0a
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      spl effective time
      20260515
      spl set id
      7e67e73e-ddf4-4e4d-8b50-09d7514910b6
    2. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-d8b7d103824366689c0e
      requested nct id
      NCT05113251
      primary nct id
      NCT05113251
      source kind
      fda_approval_notice
      source record id
      fda-a25466af65cfcdc1
      source file sha256
      aad49cf422484a3ebbae4763ae0464de8899292d956b2f72389b35cebdbafed8
      payload sha256
      796786d9e886de5f90fe175e0a56b9d4488c2a49aabd7d38295cbda2f5cf2cdb
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-d8b7d103824366689c0e
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT05113251
      occurrences
      1. context exact
        er/daf/index.cfm">Drugs@FDA</a> .&nbsp;</p><h2>Efficacy and Safety</h2><p>Efficacy&nbsp;of T-DXd followed by THP (T-DXd-THP) was evaluated in DESTINY-Breast11 (NCT05113251), a randomized, three-arm, open-label, multicenter trial that enrolled 927 adults with HER2-positive, high-risk, early-stage breast cancer. Patients were rando
        end
        26161
        exact text
        NCT05113251
        start
        26150
      offset unit
      unicode_code_points
      source event date
      2026-05-15
      source file
      /tmp/cancer-full-research/updates/pages/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage.html
      source file sha256
      aad49cf422484a3ebbae4763ae0464de8899292d956b2f72389b35cebdbafed8
      source json pointer
      Source null
      source kind
      fda_approval_notice
      source record id
      fda-a25466af65cfcdc1
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      aad49cf422484a3ebbae4763ae0464de8899292d956b2f72389b35cebdbafed8
      source title
      FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer

    Preserved source evidence · Not medical advice