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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05113251
Collaborator
Daiichi Sankyo, Inc. (Industry)
624
Enrollment
190
Locations
3
Arms
56
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
624 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are assigned to one of three arms in parallel for the duration of the study.Participants are assigned to one of three arms in parallel for the duration of the study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 25, 2021
Anticipated Primary Completion Date :
Feb 5, 2024
Anticipated Study Completion Date :
Jun 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Trastuzumab deruxtecan

Drug: Trastuzumab Deruxtecan
administered by intravenous infusion
Other Names:
  • T-DXd
  • Enhertu

    		•
    Experimental: Arm B

    T-DXd, followed by THP

    Drug: Trastuzumab Deruxtecan
    administered by intravenous infusion
    Other Names:
  • T-DXd
  • Enhertu

    • 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:
  • Neosar
  • Cytoxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. rate of pathologic complete response (pCR) [Up to 32 months after study start]

      Proportion of participants who have no evidence by H&E staining of residual invasive disease

    Secondary Outcome Measures

    1. Event-Free Survival [Up to 62 months after study start]

    2. Invasive Disease-Free Survival (IDFS) [Up to 62 months after study start]

    3. Overall Survival [Up to 62 months after study start]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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)

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Springdale Arkansas United States 72762
    2 Research Site Beverly Hills California United States 90211
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    Sponsors and Collaborators

    • AstraZeneca
    • Daiichi Sankyo, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05113251
    Other Study ID Numbers:
    • D967RC00001
    First Posted:
    Nov 9, 2021
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    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
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel
    Cyclophosphamide
    Doxorubicin
    Trastuzumab
    Pertuzumab

    Study Results

    No Results Posted as of Jul 13, 2022