Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2029
  • participants needed
    1134
  • sponsor
    AstraZeneca
Updated on 18 July 2021

Summary

The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.

Description

Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.

The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Details
Condition Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic, Breast Cancer; HER2-positive; Metastatic
Treatment Placebo, Trastuzumab, Pertuzumab, Taxane, Trastuzumab deruxtecan
Clinical Study IdentifierNCT04784715
SponsorAstraZeneca
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be 18 years of age
Pathologically documented breast cancer that
is advanced or metastatic
is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+)
is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis
Has protocol-defined adequate organ and bone marrow function

Exclusion Criteria

Ineligible for any of the agents on the study
Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results
Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study
Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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