We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05113251
Recruitment Status : Recruiting
First Posted : November 9, 2021
Last Update Posted : March 9, 2023
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Breast Neoplasms Breast Cancer HER2-positive Early Breast Cancer Drug: Trastuzumab Deruxtecan Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab Drug: Doxorubicin Drug: cyclophosphamide 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : October 25, 2021
Estimated Primary Completion Date : February 5, 2024
Estimated Study Completion Date : June 26, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Perjeta

Drug: Doxorubicin
administered by intravenous infusion
Other Names:
  • Adriamycin
  • Rubex

Drug: cyclophosphamide
administered by intravenous infusion
Other Names:
  • Neosar
  • Cytoxan


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. rate of pathologic complete response (pCR) [ Time Frame: 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 [ Time Frame: Up to 62 months after study start ]
  2. Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 62 months after study start ]
  3. Overall Survival [ Time Frame: Up to 62 months after study start ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05113251


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 206 study locations
Sponsors and Collaborators
AstraZeneca
Daiichi Sankyo, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05113251    
Other Study ID Numbers: D967RC00001
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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
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

Layout table for additional information
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:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cyclophosphamide
Doxorubicin
Trastuzumab
Pertuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological